- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02536690
Remifentanil and Midazolam on Propofol for Loss of Consciousness
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gangnam-gu
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Seoul, Gangnam-gu, Korea, Republic of, 135-720
- Gangnam Severance Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The patients who are scheduled to undergo general anesthesia for a surgery.
Exclusion Criteria:
- ASA class (American Society of Anesthesiologist physical status classification) II or higher
- Patients with history of allergy or side effects on propofol, remifentanil, midazolam
- BMI (body mass index) less than 20 or higher than 30
- Pregnancy
- Patients taking sedatives or hypnotic agents.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group P
Induction with propofol bolus.
Dose will be started at 1 mg/kg and will be adjusted as described in summary.
|
Propofol bolus dose administration according to the predetermined dose by biased coined design up-and-down study.
Other Names:
|
Active Comparator: Group PR
Induction with propofol and remifentanil.
Remifentanil infusion 0.25 mcg/kg/min for 5 min followed by propofol bolus Propofol dose will be started at 1 mg/kg and will be adjusted as described in summary.
|
Propofol bolus dose administration according to the predetermined dose by biased coined design up-and-down study.
Other Names:
Remifentanil 0.25 mcg/kg/min infusion for 5 min before propofol administration.
Other Names:
|
Active Comparator: Group PMR
Induction with propofol, midazolam and remifentanil. Remifentanil infusion 0.25 mcg/kg/min for 5 min followed by midazolam 0.03 mg/kg bolus 1 min after remifentanil infusion start and propofol bolus administration. Propofol dose will be started at 1 mg/kg and will be adjusted as described in summary. |
Propofol bolus dose administration according to the predetermined dose by biased coined design up-and-down study.
Other Names:
Remifentanil 0.25 mcg/kg/min infusion for 5 min before propofol administration.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Loss of verbal response and eyelash reflex
Time Frame: 2 minutes after propofol administration
|
Checking verbal response by verbal stimulation (yes or no) and reflex by palpation of the levator palpebrae (yes or no).
|
2 minutes after propofol administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean blood pressure
Time Frame: baseline, propofol administration time (Just after finishing monitoring on the patient in P group, 5 minutes after remifentanil infusion start in PR and PMR group), 1 minute and 2 minutes after propofol administration
|
To compare differences among groups in mean blood pressure change (mmHg).
|
baseline, propofol administration time (Just after finishing monitoring on the patient in P group, 5 minutes after remifentanil infusion start in PR and PMR group), 1 minute and 2 minutes after propofol administration
|
Heart rate
Time Frame: baseline, propofol administration time (Just after finishing monitoring on the patient in P group, 5 minutes after remifentanil infusion start in PR and PMR group), 1 minute and 2 minutes after propofol administration
|
To compare differences among groups in heart rate change (mmHg).
|
baseline, propofol administration time (Just after finishing monitoring on the patient in P group, 5 minutes after remifentanil infusion start in PR and PMR group), 1 minute and 2 minutes after propofol administration
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Dong Woo Han, MD, PhD, Department of Anesthesiology and Pain medicine, Gangnam Severance Hospital, Seoul, Korea
Publications and helpful links
General Publications
- Conway DH, Hasan SK, Simpson ME. Target-controlled propofol requirements at induction of anaesthesia: effect of remifentanil and midazolam. Eur J Anaesthesiol. 2002 Aug;19(8):580-4. doi: 10.1017/s0265021502000935.
- Choi SH, Min KT, Lee JR, Choi KW, Han KH, Kim EH, Oh HJ, Lee JH. Determination of EC95 of remifentanil for smooth emergence from propofol anesthesia in patients undergoing transsphenoidal surgery. J Neurosurg Anesthesiol. 2015 Apr;27(2):160-6. doi: 10.1097/ANA.0000000000000094.
- Koh JC, Park J, Kim NY, You AH, Ko SH, Han DW. Effects of remifentanil with or without midazolam pretreatment on the 95% effective dose of propofol for loss of consciousness during induction: A randomized, clinical trial. Medicine (Baltimore). 2017 Dec;96(49):e9164. doi: 10.1097/MD.0000000000009164.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Consciousness Disorders
- Unconsciousness
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Remifentanil
- Midazolam
- Propofol
Other Study ID Numbers
- 2015-0183-004
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