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Completed

NCT Number: NCT02536690

Remifentanil and Midazolam on Propofol for Loss of Consciousness

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.

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Key information

Conditions

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

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gangnam Severance hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol

Drug

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

Other names: Fresofol

Remifentanil

Drug

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

Other names: Ultiva

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.

Other names: Vascam

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Severance Hospital

Other

Registry information

Official study title

The Effect of Remifentanil and Midazolam on Propofol for Loss of Consciousness During Induction of Anesthesia

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 1, 2015
Registry last updated
Jun 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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