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Remifentanil and Midazolam on Propofol for Loss of Consciousness

NCT02536690 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-06-02

No results posted yet for this study

Summary

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.

Conditions

  • Anesthesia

Interventions

DRUG

Propofol

Propofol bolus dose administration according to the predetermined dose by biased coined design up-and-down study.

DRUG

Remifentanil

Remifentanil 0.25 mcg/kg/min infusion for 5 min before propofol administration.

DRUG

Midazolam

Remifentanil 0.25 mcg/kg/min infusion for 5 min before propofol administration followed by midazolam 0.03 mg/kg administration 1 min after remifentanil infusion start.

Sponsors & Collaborators

  • Severance Hospital

    lead OTHER

Principal Investigators

  • Dong Woo Han, MD, PhD · Department of Anesthesiology and Pain medicine, Gangnam Severance Hospital, Seoul, Korea

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02536690 on ClinicalTrials.gov