Remifentanil and Midazolam on Propofol for Loss of Consciousness

NCT02536690 | Completed DMC

• 1 other identifier: 2015-0183-004
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

propofol; midazolam; remifentanil; combination; synergic; pharmacodynamics; Loss of consciousness

Outcome Measures

Primary Outcomes (1)

• Loss of verbal response and eyelash reflex

  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 Outcomes (2)

• Mean blood pressure

  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

  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

Study Arms (3)

Group P

ACTIVE COMPARATOR

Induction with propofol bolus. Dose will be started at 1 mg/kg and will be adjusted as described in summary.

Drug: Propofol

Group PR

ACTIVE COMPARATOR

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.

Drug: Propofol; Drug: Remifentanil

Group PMR

ACTIVE COMPARATOR

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.

Drug: Propofol; Drug: Remifentanil; Drug: Midazolam

Interventions

Propofol DRUG

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

Also known as: Fresofol

Group P; Group PMR; Group PR

Remifentanil DRUG

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

Also known as: Ultiva

Group PMR; Group PR

Midazolam DRUG

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.

Also known as: Vascam

Group PMR

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The patients who are scheduled to undergo general anesthesia for a surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Severance Hospital: lead

Study Sites (1)

Gangnam Severance hospital

Seoul, Gangnam-gu, 135-720, South Korea

Location

Related Publications (3)

• 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.

  PMID: 12200947 BACKGROUND

• 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.

  PMID: 25105828 BACKGROUND

• 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.

  PMID: 29245361 DERIVED

MeSH Terms

Conditions

Unconsciousness

Interventions

Propofol; Remifentanil; Midazolam

Condition Hierarchy (Ancestors)

Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Dong Woo Han, MD, PhD

  Department of Anesthesiology and Pain medicine, Gangnam Severance Hospital, Seoul, Korea

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical fellow in department of anesthesiology and pain medicine

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: September 1, 2015
• Study Start: August 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 2, 2016

Record last verified: 2016-05

Locations

KR (1)