Anesthesia Clinical Trial
Official title:
The Effect of Remifentanil and Midazolam on Propofol for Loss of Consciousness During Induction of Anesthesia
Propofol in combination with remifentanil or midazolam can result in synergistic or additive
effect.
The patients who are scheduled to undergo general anesthesia are enrolled in this study. 120
patients will be randomly allocated to 3 groups(P, PR, PMR). The patients in group P will
receive general anesthesia only with propofol and group PR and PMR will receive 0.25
mcg/kg/min remifentanil infusion prior to propofol. The patients in group PMR will receive
0.03 mg/kg bolus dose of midazolam 1 min after start of the remifentanil infusion. 'Success'
is defined as loss of both verbal response and eyelash reflex in 2 min after propofol
administration. When 'success', the next patient will receive the same dose(in 18/19
probability) or 0.25 mg/kg lower dose(in 1/19 probability) of propofol. When 'failure', the
next patient will receive 0.25 mg/kg higher dose of propofol at induction period.
Propofol is a well-known induction agent which can provide sound and quick hypnosis with
anti-emetic effects. However, dose dependent hypotension or bradycardia have reported while
using this agent. Propofol in combination with remifentanil or midazolam can result in
synergistic or additive effect. There are not many studies which provide minimum dose of
propofol to induce hypnosis in combination with these agents and advantage of the
combination.
The patients who are scheduled to undergo general anesthesia are enrolled in this study. 120
patients will be randomly allocated to 3 groups(P, PR, PMR). Sample size have been decided
due to the previous studies which have mentioned 40 participants as a adequate sample size
for this biased coin design - up and down study.
After receiving informed consent, patients will be participated in this study. No
premedication will be given to the patients before induction. The patients in group P will
receive general anesthesia only with propofol and group PR and PMR will receive 0.25
mcg/kg/min remifentanil infusion for 5 min prior to propofol administration. The patients in
group PMR will receive 0.03 mg/kg bolus dose of midazolam 1 min after the start of the
remifentanil infusion. Initial propofol dose will be 1 mg/kg in each group and the dose will
be changed by the result of prior study participant.
'Success' of this study will be defined as loss of both verbal response and eyelash reflex
in 2 min after propofol administration. When 'success', the next patient will receive the
same dose(in 18/19 probability) or 0.25 mg/kg lower dose(in 1/19 probability) of propofol.
When 'failure', the next patient will receive 0.25 mg/kg higher dose of propofol at
induction period.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver)
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