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Hypnotics and Opioids

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Hypnotics and Opioids



Steven L. Shafer, M.D.

Professor of Anesthesia, Stanford University

Adjunct Professor of Biopharmaceutical Science, UCSF

Editor in Chief, Anesthesia & Analgesia

Disclosure

 I have consulted for AstraZeneca

(propofol), Roche (midazolam), Theravance

(THRX-918661), Guilford (Aquavan),

Glaxo (remifentanil).

 I have done clinical trials for AstraZeneca

(propofol), Roche (midazolam, novel

benzodiazepines, novel targets), and Glaxo

(remifentanil), Janssen (fentanyl,

alfentanil).

-aminobutyric acid

 a.k.a GABA

 Most widespread inhibitory neurotransmitter in the CNS

 Three classes of receptors

 GABAA

 Ligand gated ion channel

 Cl- channel

 Site of action of benzodiazepines, barbiturates, and propofol

 Not the site of action of inhaled anesthetics

 GABAB

 Slow inhibitory post-synaptic potentials, regulates K+ and Ca++

conductance

 Not a binding site of anesthetic drugs

 GABAC

 Also a Cl- channel

 Not a binding site of anesthetic drugs

GABAA Receptor

 Transmembrane pentamer

composed of 2 , 2 , and 1 

or  subunits

– Each has a binding site for

GABA

 Benzodiazepines

– Bind a cleft of  and 

subunits

 Barbiturates

– Bind  subunit

 Propofol/Etomidate

– Bind  subunit

 Antagonist: bicuculine

Midazolam vs. Diazepam







The Introduction of

Versed ®

Midazolam and Diazepam Clinical Pharmacology

(as originally introduced into clinical practice)









Elimination Equipotent

Onset Half-Life Duration Doses

Diazepam "slow" 40 hr "long" 10 mg

Midazolam "fast" 4 hr "short" 5 mg

Result of initial dosing

guidelines

 1600 adverse reactions and 86 deaths

associated with midazolam in the first 5

years after its introduction in the United

States.

 Department of Health and Human Services, Office of

Epidemiology and Biostatistics, Center for Drug

Evaluation and Research, Data Retrieval Unit HFD-

737, June 27, 1989

 Nearly all were associated with midazolam

for sedation during endoscopy

FDA’S REGULATION OF THE NEW DRUG

VERSED



HEARINGS

BEFORE A



SUBCOMMITTEE OF THE



COMMITTEE ON

GOVERNMENT OPERATIONS

HOUSE OF REPRESENTATIVES

ONE HUNDREDTH CONGRESS

SECOND SESSION





MAY 5 AND 10, 1988

Midazolam Sedation for

15

Endoscopy

Sedative Dose (mg)



10





5





0

0 20 40 60 80 100

Age (years)

Adapted from Bell, J Clin Pharmacol 1987 Feb;23(2):241-3

Midazolam-Opioid Interactions

Midazolam ED50 (mg) (young volunteers)



20

15

10

5

0

0 500 1000 1500 Alfentanil (g)

[0] [135] [270] [400] [fentanyl - (g)]



Adapted from Kissen et al, Anesth Analg 72:65-69, 1990

Benzodiazepine EEG Effects

EEG Amplitude within 11.5-30 Hz ( V/sec)

Midazolam Flumazenil











Bretazenil







Ro 19-4603







Blood concentration ( g/ml)

EEG Effects of Midazolam









Adapted from Bührer, CPT 48:555-567, 1990

Revised Midazolam

Comparative Pharmacology



Plasma-Effect Site

Equilibration Half-Life Potency

range (average) range (mean)

1-2.4 min 406-1256 ng/ml

Diazepam (1.6 min) (958 ng/ml)



1.6-6.8 min 94-385 ng/ml

Midazolam

(4.8 min) (190 ng/ml)

Sedation and Amnesia:

Propofol vs. Midazolam

 67 volunteers, randomized, open label

50% Memory

Sedation Loss

Midazolam (ng/ml) 64 56

Propofol (g/ml) 70 62

Thiopental (ug/ml) 2.9 4.5

Fentanyl (ng/ml) 0.9 3.2



 No difference between relative sedative and amnestic

profiles for propofol and midazolam

 Big difference with thiopental and fentanyl from propofol

or midazolam

 Vesalis et al, Anesthesiology 1997 87:749-64

Sedation and Amnesia:

Propofol vs Midazolam

 Randomzed, blinded cross-over trial in 10

voluneers

 Titrated to different levels of sedation:

Propofol Midazolam

Lethargic 1350 208

Asleep 1620 249



– Steep change in effect with small change in concentration

 Could not distinguish memory impairment between

propofol and midazolam

 de Roode, et al, Anesth Analg 2000 91:1056-61

Propofol PK and age



5

Propofol ( g/ml)









4 25 years old

50 years old

3 75 years old

2

1

Infusion

0

60 120 180 240 300 360

Time in minutes

Schnider et al, Anesthesiology 88:1170-1182, 1998

The elderly brain is more sensitive to propofol

Probability of unconsciousness after a 1 hour infusion



Unconscious

1.0



Probability 0.8 75 50 25



0.6



0.4



0.2



0.0 Conscious

0 2 4 6 8

Plasma propofol concentration (g/ml)



Schnider et al, Anesthesiology 1999 (in press)

After a propofol bolus, everyone

falls asleep quickly



2.0



1.5

Minutes





1.0



0.5



0.0

20 30 40 50 60 70

Age Schnider et al, Anesthesiology 1999 (in press)

But the elderly sleep longer

12

10

Minutes



8

6

4

2

0

20 30 40 50 60 70

Age

Schnider et al, Anesthesiology 1999 (in press)

Propofol dosing and age

Rate to maintain “adequate anesthesia”

350

Infusion rate (g/kg/min)





300



250 25 years old



50 years old

200

75 years old

150



100



0 10 20 30 40 50 60

Time in minutes

Based on data in

Schnider et al, Anesthesiology 88:1170-1182, 1998

Propofol Recovery

50% effect site decrement

curve

60

Minutes to a 50% decrement







Age

20



30 40

60

80





0

0 120 240 360 480 600

Minutes since beginning of infusion

Propofol in the elderly:

bringing it all together



 PK: the early distribution pharmacokinetics are

slower in the elderly

 PD: the brain is more sensitive

 Ke0: no change with age

 Lower the dose in the elderly, and they should

wake up just as fast as younger patients

Propofol/Alfentanil Interaction

400

 Adapted from Vuyk









Alfentanil Concentration (ng/ml)

et al, Anesthesiology Intubation





83:8-22, 1995 300



 Characterizes the Maintenance



concentrations for 200

Emergence

 intubation

 maintenance

100

 on emergence

 Concentrations are

0

50% response level 0 2 4 6 8 10

Propofol Concentration (g/ml)

Opioid/Hypnotic Interaction

Conscious,

No Pain Attenuation Responsive









Pain in Pain Pain Afferent

in Projected Stimuli









Maximal Pain Attenuation

Opioid Hypnotic

Unconscious,

Unresponsive

Remifentanil Propofol

Probability of Tolerating

Laryngoscopy

Laryngoscopy









Pr

op

ofo

l ( l)

g/m (ng/m

l) entanil

Remif

Remifentanil Propofol

Probability of Hypnosis Hypnosis









Pr

op

ofo

l ( )

g/m

l) il (n g/ml

ntan

Re mife

Remifentanil Propofol

BIS Interaction, Laryngoscopy

5%







95%

BIS









Pr

op

ofo

l TC l)

I( CI (ng/m

g/m il T

l) ifentan

Rem

Modeling of opioid/hypnotic

interaction

400



Alfentanil Concentration (ng/ml) Intubation



300



Maintenance



200

Emergence





100





0

0 2 4 6 8 10

Propofol Concentration (g/ml)

Adapted from Vuyk et al, Anesthesiology 83:8-22, 1995

ro lnl mn n

o l fti1i t u

p/ e :

o a n s

e i

PfAn0 u f oi

0

4





0

3





0

2





0

1

Minutesinceturnigofinusion



0



Aa0/l

le0n )

f1i(g

n2 m

tn00

0

l3 64

20

0 8

0 20

4 11

0

rom)

Pf(c l

pl /

oo gm

Propofol/Alfentanil: 10 minute infusion









0





0

10 0

2

Al









0

20

fe









4 l)

nta









6 cg/m

nil









0 m

30 8 l(

(ng









0 ofo

rop

1

/m









0 P

l)









40 12

Propofol/Alfentanil: 20 minute infusion





Minutes since turning off infusions

40





30





20





10





0

Al 100 0

fen 200 2

4

/ml)

tan 6

300 8

il 10 m cg

(ng 400 12 fol (

/m Propo

l)

Propofol/Alfentanil: 60 minute infusion





Minutes since turning off infusions

40





30





20





10





0

Al 100 0

fen 200 2

4

/ml)

tan 6

300 8

il 10 m cg

(ng 400 12 fol (

/m Propo

l)

Propofol/Alfentanil: 300 minute infusion



Minutes since turning off infusions

40





30





20





10





0

100

Al

fen 2 00 2 0

4

/ml)

tan 0 6

30 8

il (

400 12 10 l (mcg

ng

/m Propofo

l)

Propofol/Alfentanil: 600 minute infusion



Minutes since turning off infusions

40





30





20





10





0

100

Al

fen 2 00 2 0

4

/ml)

tan 0 6

30 8

il (

400 12 10 l (mcg

ng

/m Propofo

l)

10 Minute Infusion

Fentanyl Alfentanil









Minutes since turning off infusions

Minutes since turning off infusions

40 40





30 30





20 20





10 10





0 0

1 0

Fe 2 Al 10 00

nta 3 2 0 fen 2 2 0

ny 4 4 4

6

/ml) l)

tan 6

l( 300

ng 5 6 10

8

mcg il ( 10

8

cg/m

/m 12 ofol

( ng 400 12

ofo l (m

l) Prop /m

l) Prop



Sufentanil Remifentanil









Minutes since turning off infusions

Minutes since turning off infusions









40 40





30 30





20 20





10 10





0 0

Su 0.10.2 Re 2

fen 0.3 2 0 mi 4 2 0

tan 0.4 4 fen 4

/ml)

6 6

il ( 0.5 8 /ml) tan 6 8

ng .6 12 10 (mcg il ( 8 2 10 (mcg

/m

0

ofol ng 1 ofol

l) Prop /m Prop

l)

600 Minute Infusion

Fentanyl Alfentanil









Minutes since turning off infusions

Minutes since turning off infusions

40 40





30 30





20 20





10 10





0 0

Fe 1 2 0

Al 10 00

nta 3 2 0 fen 2 2 0

ny 4 4 4

/ml)

6 tan 6

l( 8 /ml) 300 8

ng 5 6 10 (mcg il ( 00 12 10 (mcg

/m 12 ofol ng 4

ofol

l) Prop /m

l) Prop



Sufentanil Remifentanil









Minutes since turning off infusions

Minutes since turning off infusions









40 40





30 30





20 20





10 10





0 0

Su 0.10.2 Re 2

fen 0.3 2 0 mi 2 0

tan 0.4 4 fen 4 4

6

/ml) tan 6 6 l)

il ( 0.5 10

8

mcg il ( 0

8

cg/m

ng 0.6 12

ofol ( ng

8 2 1

1 ofo l (m

/m

l) Prop /m

l) Prop

Propofol/Opioid

Propofol Levels (g/ml)

Alfentanil Technique Remifentanil Technique

6





4 Maintenance

Maintenance

2

Emergence Emergence



0



0 120 240 360 480 600 120 240 360 480 600

Time (Minutes) Time (Minutes)

Shafer SL, ASA Refresher Course, Chapter 19, 19

Propofol/Opioid

Percent Decrease on Emergence

Alfentanil Technique Remifentanil Technique

100

75

Remifentanil

Propofol

50

Propofol

25 Alfentanil

0



0 120 240 360 480 600 120 240 360 480 600

Time (Minutes) Time (Minutes)

Shafer SL, ASA Refresher Course, Chapter 19, 19

Propofol/Opioid

Time to Awakening

Alfentanil Technique Remifentanil Technique

20



15



10



5



0



0 120 240 360 480 600 120 240 360 480 600

Time (Minutes) Time (Minutes)

Shafer SL, ASA Refresher Course, Chapter 19, 19

Propofol/Remifentanil TIVA

400

 Remifentanil:







Infusion Rates

300 Remifentanil (ng/kg/min)

200

 0.25 g/kg/min 100

0 Propofol (g/kg/min)

 Propofol: 20









Recovery Time

15



 80 g/kg/min 10

5

0

 Requires 0 120 240 360 480 600



controlled Time (Minutes)



ventilation Shafer SL, ASA Refresher Course, Chapter 19, 1







 Little tolerance for interruption of remifentanil

or propofol infusion

Interaction on Ventilatory Depression









Nieuwenhuijs et al, Anesthesiology 2003,98:312-22

Propofol/opioid vs Isoflurane/opioid

20

Minutes Required for Emergence









15

60-80% Isoflurane Decrement



10



50-67% Propofol Decrement



5







0

0 10 20 30 40 50 60



Duration of Anesthesia

Propofol/opioid vs Isoflurane/opioid



120

Minutes Required for Emergence









90

50-67% Propofol

Decrement

60







30



60-80% Isoflurane Decrement



0

0 120 240 360 480 600



Duration of Anesthesia

Propofol Formulations

 Cyclodextrin

Propofol

– water-soluble cyclic

carbohydrates

– Egan et al:

Equivalent PK/PD to

Diprivan

 Anesthesiology 2001;

95:A490





Baker MT, Naguib M. . Anesthesiology. 2005;103:860-76.

Propofol Formulations

 Propofol micelles

– Formulations are clear

– Associated with substantial

increase in pain on

injection

– “Cleofol” recently been

introduced in India.

 89% incidence of severe pain

on injection

 Venous phlebitis

 Damages infusion sets,

 “should only be used for

patients who demand a pure

vegetarian induction agent”

Baker MT, Naguib M. . Anesthesiology. 2005;103:860-76.

Propofol Prodrug

 “Aquavan”

– Water soluble

– VERY slow onset – 10

minutes or so

– Difficult to titrate

 Recent phase III data

suggest that perhaps it

is titratable

 Causes “a transient unpleasant

– Being developed for sensation of burning or

procedural sedation tingling of moderate severity

in the anal and genital

region.”





Baker MT, Naguib M. . Anesthesiology. 2005;103:860-76.

Novel GABAergic Hypnotic:

THRX-918661

Pig EEG study:

• 20 minute infusion (n=4)

100



80

BIS value









60 THRX-918661 (1.5mg/kg/min)

Diprivan (0.5mg/kg/min)

40



20



Infusion

0

0 5 10 15 20 25 30 35 40 45 50 55 60

Time (mins)

Beattie et al, SIVA UK, May

THRX-918661 vs propofol in Rats

70



60

Duration (mins) of loss

of the righting reflex



50

Diprivan (20mins)

40 Diprivan (3hrs)

30 Diprivan (5hrs)

20

THRX-918661 (20mins)

10

THRX-918661 (3hrs)

THRX-918661 (5hrs)

0



120

Duration (mins) for









90

total recovery









60





30





0



Beattie et al, SIVA UK, May

THRX-918661 vs. propofol in Rats

THRX- 918661 Propofol

3mg/kg i.v.

10mg/kg i.v.









30mg/kg i.v. 10mg/kg i.v.









Beattie et al, SIVA UK, May

Classical Opioid

Pharmacology

 Analgesia

 modest to profound with no ceiling effect

 Sedation

 modest to profound, but has a ceiling effect

 unconsciousness cannot be assured

 Reduces MAC

 with a ceiling effect

 Synergy with hypnotics

 modest at causing sedation

 profound at suppressing movement response to noxious

stimulation

Classical Opioid

Pharmacology



 High dose opioids are associated with

hemodynamic stability



 High dose opioids attenuate the stress

response

Classical Opioid

Pharmacology

 Ventilatory depression  Urinary retention

 Muscle Rigidity  Ileus

 Nausea, Vomiting  Addiction potential

 Pruritis  Opioid Induced

Hyperalgesia

Pure  agonists (intravenous)

 Intraoperative  Postoperative

– Fentanyl – Morphine

– Alfentanil – Hydromorphone

– Sufentanil – Meperidine

– Remifentanil – Methadone

Distinguishing Characteristics

 Pharmacokinetics

– Rate of Onset

– Rate of Offset

 Pharmacodynamics

– Potency

– Most have one or two peculiarities

Opioid Onset

100 Hydromorphone

Methadone

Percent of peak effect







Meperidine

site concentration





Morphine

80

Sufentanil



60

Fentanyl



40

Alfentanil

20

Remifentanil

0

0 5 10 15 20

Minutes since bolus injection

Opioid Onset

100 Morphine

Percent of peak effect

site concentration





80



Hydromorphone

60



40

Meperidine





20 Methadone

Fentanyl

Sufentanil

Alfentanil

Remifentanil

0

0 30 60 90 120

Minutes since bolus injection

Morphine

 Endogenous ligand

 Slow rise to peak effect

 Absolute peak analgesic effect is at 90 minutes after bolus

injection!

 Active metabolite

 Morphine-6-glucuronide is unlikely to contribute to analgesic

effects at standard OR doses. Will contribute to effects with

chronic dosing

 Especially in renal failure

 Releases histamine

 Not as full efficacy as fentanyl series of opioids

Morphine Onset

100

Percent of peak effect

site concentration





80



60



40



20



0

0 30 60 90 120

Minutes since bolus injection

Simulation of Morphine

Time Course









Dahan et al. Anesthesiology.

2004;101:1201-9.

Morphine Pharmacokinetics

100

Percent of initial concentration









10





1





0.1





0.01

0 240 480 720 960 1200 1440

Minutes since bolus injection

Fentanyl

 Pharmacologically “clean”

 100% efficacious (in contrast to morphine)

 The first of the “fentanyl” series

(obviously…)

 Available in transdermal, submucosal,

sublingual, and (soon) inhaled forms.

 Free!

Morphine vs. Fentanyl PK

100

Percent of initial concentration









Morphine

10

Fentanyl









1

0 5 10 15 20 25 30

Minutes since bolus injection

Morphine vs. Fentanyl PK

100

Percent of initial concentration









10





1

Fentanyl





Morphine

0.1





0.01

0 240 480 720 960 1200 1440

Minutes since bolus injection

Morphine vs. Fentanyl Onset

100

Percent of peak effect

site concentration





Morphine

80



60

Fentanyl



40



20



0

0 5 10 15 20

Minutes since bolus injection

Morphine vs. Fentanyl Onset

100 Morphine

Percent of peak effect

site concentration





80



60



40



20

Fentanyl





0

0 30 60 90 120

Minutes since bolus injection

Morphine vs. Fentanyl PK

100

Percent of initial concentration









10





1

Fentanyl





Morphine

0.1





0.01

0 240 480 720 960 1200 1440

Minutes since bolus injection

Hydromorphone

 A rapid onset morphine

 No histamine release

 About 8 fold more potent than morphine

 No active metabolite

 Good choice for PCA, post-op analgesia

Comparative Hydromorphone PK

100

Percent of initial concentration









Morphine

10

Fentanyl







Hydromorphone









1

0 5 10 15 20 25 30

Minutes since bolus injection

Comparative Hydromorphone PK

100

Percent of initial concentration









10





1

Fentanyl

Morphine



Hydromorphone

0.1





0.01

0 240 480 720 960 1200 1440

Minutes since bolus injection

Hydromorphone Onset

100 Hydromorphone

Percent of peak effect

site concentration





Morphine

80



60

Fentanyl



40



20



0

0 5 10 15 20

Minutes since bolus injection

Hydromorphone Onset

100 Morphine

Percent of peak effect

site concentration





80



Hydromorphone

60



40



20

Fentanyl





0

0 30 60 90 120

Minutes since bolus injection

Comparative Hydromorphone PK

100

Percent of initial concentration









10





1

Fentanyl

Morphine



Hydromorphone

0.1





0.01

0 240 480 720 960 1200 1440

Minutes since bolus injection

Sufentanil

 10 fold more potent than fentanyl

 Slightly slower onset than fentanyl

 More rapid recovery (“context sensitive half

time”) than fentanyl

 Very clean pharmacologically

Comparative Sufentanil PK

100

Percent of initial concentration









10

Sufentanil



Morphine

Fentanyl









1

0 5 10 15 20 25 30

Minutes since bolus injection

Comparative Sufentanil PK

100

Percent of initial concentration







10





1





0.1





0.01

0 240 480 720 960 1200 1440

Minutes since bolus injection

Sufentanil Onset

100 Hydromorphone

Percent of peak effect

site concentration





Morphine

80

Sufentanil



60

Fentanyl



40



20



0

0 5 10 15 20

Minutes since bolus injection

Sufentanil Onset

100 Morphine

Percent of peak effect

site concentration





80



Hydromorphone

60



40



20

Fentanyl

Sufentanil



0

0 30 60 90 120

Minutes since bolus injection

50% effect site

decrement curves

120

Minutes required





fentanyl

90

alfentanil

60



30 sufentanil



0



0 120 240 360 480 600

Minutes since beginning of infusion

Minto et al, Anesthesiology 86:10-23,

Meperidine

 Bad Drug! No role in the management of pain

 Toxic metabolite

 Normeperidine  seizures

 Renally excreted

 Negative inotrope

 Causes tachycardia (anticholinergic)

 Complex interactions

 MAO syndrome when combined with MAO inhibitors

 Useful for shivering

 Possibly useful as a local anesthetic

Meperidine Onset

100 Hydromorphone

Percent of peak effect







Meperidine

site concentration





Morphine

80

Sufentanil



60

Fentanyl



40



20



0

0 5 10 15 20

Minutes since bolus injection

Meperidine Onset

100 Morphine

Percent of peak effect

site concentration





80



Hydromorphone

60



40

Meperidine





20

Fentanyl

Sufentanil



0

0 30 60 90 120

Minutes since bolus injection

Alfentanil

 Less potent than fentanyl

 Much more rapid onset (including more

rapid onset of rigidity and respiratory

depression)

 Much more evanescent effect with a single

bolus

 With brief infusions will be almost

indistinguishable from fentanyl, except for

potency

Remifentanil

 Similar potency to fentanyl

 Pharmacokinetics are in a class by

themselves (ester metabolism)

 Reduce the dose by about 2/3s in the elderly

 No pharmacokinetic interactions

 Onset is similar to alfentanil

Onset of fentanyl series opioids

sufentanil

100

Percent of peak effect site

opioid concentration



80

fentanyl



60



alfentanil

40



20

remifentanil

0

0 2 4 6 8 10

Minutes since bolus injection

Minto et al, Anesthesiology 86:10-23,

Comparative Onset of

Alfentanil and Remifentanil

Hydromorphone

100

Percent of peak effect









80

site concentration









Morphine



60 Fentanyl







40

Alfentanil

20

Remifentanil





0

0 5 10 15 20

Minutes since bolus injection

Remifentanil Metabolism

• Extremely rapid

• Not influenced by:

• Hepatic disease

• Renal disease

• Pseudocholinesterase deficiency

• Administration of neostigmine

• Very young age

• Modest decrease in elderly patients

The remifentanil

“Unit Disposition Function” 0.1

0.1

• Expected plasma

concentration 0.01 0.01









Unit dispostion function

• following bolus of 1 unit

0.001 0.001

0 10 20

• Age range: 20-85 yrs

0.0001







• Very rapid decrease 0.00001







0.000001

• Less variability than with 0 60 120 180 240

other anesthetic drugs Time (minutes)







Minto et al, Anesthesiology 86:10-23,

PK of fentanyl series opioids

100

Percent of peak plasma

opioid concentration





10





fentanyl

1 sufentanil



alfentanil

remifentanil

0.1



0 120 240 360 480 600

Minutes since bolus injection

Minto et al, Anesthesiology 86:10-23,

50% effect site

decrement curves

120

Minutes required





fentanyl

90

alfentanil

60



30 sufentanil

remifentanil

0



0 120 240 360 480 600

Minutes since beginning of infusion

Minto et al, Anesthesiology 86:10-23,

Methadone

 Longest terminal half-life (about 1 day)

 May accumulate during titration to steady

state

 VERY BAD IDEA TO SEND PATIENTS

HOME ON METHADONE

 Supplied as a racemic mixture

 L methadone is an opioid agonist

 D methadone is an NMDA antagonist

 Underutilized in anesthesia practice

Methadone Onset

100 Hydromorphone

Methadone

Percent of peak effect







Meperidine

site concentration





Morphine

80

Sufentanil



60

Fentanyl



40

Alfentanil

20

Remifentanil

0

0 5 10 15 20

Minutes since bolus injection

Methadone Onset

100 Morphine

Percent of peak effect

site concentration





80



Hydromorphone

60



40

Meperidine





20 Methadone

Fentanyl

Sufentanil

Alfentanil

Remifentanil

0

0 30 60 90 120

Minutes since bolus injection

Methadone PK

100

Percent of initial concentration









10 Meperidine

Sufentanil

Alfentanil

Morphine

Fentanyl









Remifentanil

1

0 5 10 15 20 25 30

Minutes since bolus injection

Methadone PK

100

Percent of initial concentration







10





1





0.1

Remifentanil





0.01

0 240 480 720 960 1200 1440

Minutes since bolus injection

Context Sensitive Half Time



300









yl

Minutes to 50% decrement









an

nt

in plasma concentration









Fe

240



in e

180 Meperid









120

one

thad

Me

Alfentanil

60

Sufentanil Morphine

Hydromorphone

Remifentanil

0

0 120 240 360 480 600

Rise to Steady State

Remifentanil

100

Fraction of Steady State









80

il e

an ridin

nt epe

Alfe M

phone

60 Hydromor

tanil

Sufen

ine nyl

r ph F enta

Mo

e

40 Methadon









20





0

0 120 240 360 480 600

Infusion Duration

Intraoperative potency:

100 g/hour fentanyl at 2 hours





Sufentanil 10 g/hr

Remifentanil 0.04 g/kg/min

Morphine 3.5 mg/hr

Methadone 2 mg/hr

Hydromorphone 0.4 mg/hr

Post Op Analgesia: 1

 Just use fentanyl for post-op analgesia

– 25 g q 5 min

 Max of 250 in young patients, 150 in elderly

– 3-5 minute peak onset provides rapid relief, but no so

rapid that the patient stops breathing

– Rapid peak makes it easy to titrate

– Nurses are familiar with it

– Logical choice for PCA

– Free

– If you can’t get the patient comfortable with fentanyl,

you won’t succeed with another opioid

 possible exception of methadone

Post Op Analgesia: 2

 Hydromorphone 0.2 mg q 10 min

– Max of 6 mg in young patients, 3 mg in elderly

– 5-10 minute peak onset provides rapid relief,

but no so rapid that the patient stops breathing

– Still easy to titrate

– Nurses are familiar with it

– Also a logical choice for PCA

– Inexpensive

Opioid Induced Hyperalgesia

 Increase in pain sensitivity following exposure to

opioids

 Well documented in animal models of pain

 Evidence in humans is accumulating

 Mechanical nociceptive pathways appear more

sensitive then thermal (heat) nociceptive pathways

 NMDA antagonists (i.e., ketamine) blocks

hyperalgesia

 Suggests a spinal mechanism





Clark and Angst, Anesthesiology 2006;104:570

OIH: High Dose Opioids

 Pain and hypersensitivity are observed in opioid addicts

during withdrawal.

– Addicts on methadone maintenance have increased sensitivity in

various pain models compared with addicts not on methadone

maintenance

 High dose fentanyl (22 g/kg) and remifentanil (0.3

g/kg/min) have been associated with increased pain and

opioid requirements in the post operative period.

– Associated with very high opioid doses.

– Not always replicated (0.23 g/kg/min remifentanil did not cause

hyperalgesia).

– Seen with IT opioids (25 g fentanyl)

– Nearly impossible to distinguish “hyperalgesia” from “tolerance”

in patients in such trials.

 Efficacy of ketamine at blocking effect suggests it is hyperalgesia, not

tolerance.





Clark and Angst, Anesthesiology 2006;104:570

OIH: Naloxone Infusions

 Two studies suggested very low naloxone infusions

improved post-operative analgesia in women undergoing

hysterectomy:

 Gan et al, Anesthesiology 1997;87:1075

 Joshi et al, Anesthesiology 1999;90:1007





 Subsequent studies failed to reproduce these results:

 Cepeda et al, Pain 2002;96:73

 Cepeda et al, Pain 2004;107:41







Clark and Angst, Anesthesiology 2006;104:570

Morphine-6-glucuronide

 Very slow transit across blood brain barrier.

 Not a substrate for p-glycoprotein, but appears to be a

substrate for probenecid inhibited transporters

(Anesthesiology 2004:101 1394)

 Recently a peptide based carrier demonstrated 4 fold

increase in uptake and potency (JPET 2005:12 epub).

 Some data show higher affinity for 1, and lower

affinity for 2, compared to morphine.

 Some suggestion that M6G is associated with less

ventilatory depression for the amount of analgesia

– (e.g., Romberg et al, Anesthesiology 2004 100:120)

Evidence of  opioid subtypes

 Only about 50% cross tolerance between

morphine, methadone, fentanyl

 Explains why rotating opioids in chronic pain is

probably a good idea

 CXBK mouse is insensitive to morphine,

but has normal response to M6G and

fentanyl

 Selective response to opioid antagonists

Gavril Pasternak, Life Sciences 2001:68, 2213

Naloxonazine

 Selectively antagonizes morphine analgesia

in animals

 1 is considered naloxonazine sensitive

 Does not antagonize morphine-induced

ventilatory depression or GI effects

 2 is considered naloxonazine insensitive







Gavril Pasternak, Life Sciences 2001:68, 2213

1 selective agonists?

 Despite evidence now 25 years old of

differential response to angatonists, nobody

has found a 1 selective agonist

 Biggest argument against it: Paul Janssen

spent years looking for one, screening over

70,000 possible ligands

 Reason for hope: perhaps our improved

knowledge of MOR-1 splice variants will help

identify the required pharmacofore

 Don’t hold your breath…

Next best thing:

give opioids, manage side effects

 Treat constipation, ileus with peripheral

antagonists

 Treat ventilatory depression with 5HT4

agonists

Peripheral  antagonist:

ADL 8-2698, alvimopan

 Restricted to the gut

– very little systemic absorption

– unable to cross blood-brain barrier

Peripheral  antagonist:

ADL 8-2698, alvimopan









Liu et al, CPT 2001,

69:66

Methylnaltrexone

 Invented by Leon Goldberg, University

of Chicago

 Effective for a variety of opioid side

effects including

– Opioid induced constipation

– Pruritis

– Post-operative ileus

 Being developed for IV/SQ/Oral

 Progenics

– Phase III trials

5HT4(a)

 Abundantly expressed in Pre-Boetzinger Complex

 Controls ventilation

 Stimulate adenylyl cyclase

 BIMU8 is a specific agonist of 5HT4(a)

 Novartis: endo-N-(8-methyl-8-azabicyclo [3.2.1]oct-3-yl)-2,3-dihydro-(1-methyl) ethyl-2-oxo-

1H-benzimidazole-1-carboxamide





 Co-locate in PBC with opioid receptors









Manze et al, Science 2003

5HT4(a)









Manze et al, Science 2003 301:226

BIMU8 reverse fentanyl ventilatory depression









Manzke et al, Science 2003 301:226

Unfortunately

 Based on the Manzke work, the 5HT4

nonspecific agonists have been tried for

efficacy in reversing opioid induced

ventilatory depression.

 They don’t work.

 Need to await development of 5HT4(a)

specific agonists.


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