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Remifentanil Only vs. Midazolam and Meperidine During Elective Colonoscopy (remifentanil)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01693185
Recruitment Status : Completed
First Posted : September 26, 2012
Results First Posted : June 18, 2014
Last Update Posted : June 18, 2014
Information provided by (Responsible Party):
Tae-Yop Kim, MD PhD, Konkuk University Medical Center

Brief Summary:
The aim of the present study is to compare patient's recovery times after elective colonoscopy employing remifentanil only vs conventional combination of midazolam and meperidine

Condition or disease Intervention/treatment Phase
Diagnostic Colonoscopy Screening Drug: Remifentanil Drug: Midazolam Drug: Meperidine Drug: placebo (for remifentanil) Drug: placebo (for midazolam) Drug: placebo (for meperidine) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Remifentanil Only vs. Combination Group Midazolam + Meperidine During Elective Colonoscopy
Study Start Date : December 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : August 2013

Arm Intervention/treatment
Experimental: Remifentanil
remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)
Drug: Remifentanil
continuous infusion 0.4 mcg/kg/min
Other Name: Ultiva

Drug: placebo (for midazolam)
normal saline mimic to midazolam injection
Other Name: normal saline

Drug: placebo (for meperidine)
normal saline mimic meperidine injection
Other Name: normal saline

Active Comparator: midazolam and meperidine
a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)
Drug: Midazolam
bolus injection
Other Name: dormicum

Drug: Meperidine
bolus injection for 30 sec 1.0 mg/kg
Other Name: Pethidine Injection

Drug: placebo (for remifentanil)
normal saline mimic diluted remifentanil
Other Name: normal saline

Primary Outcome Measures :
  1. The Recovery Time [ Time Frame: every 5 minutes after completing colonoscopy up to 30 min ]

    Time from completing the colonoscopy to achieving Aldrete score 10 in the recovery unit

    Aldrete score

    • Respiration: Able to take deep breath and cough = 2, Dyspnea/shallow breathing = 1, Apnea = 0
    • O2 saturation: Maintains > 92% on room air =2, Needs O2 inhalation to maintain O2 saturation > 90% =1 , O2 saturation < 90% even with supplemental oxygen =0
    • Consciousness: Fully awake= 2, Arousable on calling = 1, Not responding = 0
    • Circulation: BP +/- 20 mm Hg preop =2, BP +/- 20-50 mm Hg preop =1, BP +/- 50 mm Hg preop =0
    • Activity: Able to move 4 extremities = 2, Able to move 2 extremities = 1, Able to move 0 extremities = 0

    To estimate the required sample size, we conducted a pilot study to measure the recovery of 10 patients in each of groups-MM and -R before the present study. The means and standard deviations were 22.5 ± 9.5 and 7.5 ± 9.2 min respectively. We wished to be able to distinguish a difference of 7.5 min, thus half of the observed difference.

Secondary Outcome Measures :
  1. Participants Assumed to Feel Frequent Pain [ Time Frame: during and after colonoscopy ]
    patients sound "Ah" at feeling pain during colonosocpy: if a patients sounds "Ah" > 6 times, the patient was assumed to feel frequent pain.

  2. Bispectra Lindex Score [ Time Frame: every 5 min during and after colonoscopy ]
    Bispectral index (BIS) score 0-100 maximal sedation=0, maximal sedation=100

  3. Patient's Distress Score [ Time Frame: 5 min after the end of colonoscopy ]
    patients' distress in visual analogue scale 100 mm minimal distress=0, maximal distress=100

  4. Endoscopist Satisfaction [ Time Frame: 5 min after the colonoscopy ]
    endoscopist's satisfaction after colonoscopy in visual analogue scale 100 mm

  5. Indigence of Patient's Recall [ Time Frame: after colonoscopy ]
    The numbers of patients who recalled instructions and explanations given during colonoscopy

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Aged 19-65 years
  • American Society of Anesthesiologists physical status (ASA PS) 1-2
  • Patients scheduled for elective colonoscopy under Monitored Anesthesia Care in a University Hospital
  • Patients who signed on written informed consent.

Exclusion Criteria:

  • The exclusion criteria are refusal or inability to provide written informed consent
  • Age < 18 years
  • Pregnancy
  • Previous large bowel surgery
  • Psychiatric disorders
  • History of addiction to opiates and / or sedatives, and previous adverse reaction to any drug used in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01693185

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Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of, 143-729
Sponsors and Collaborators
Konkuk University Medical Center
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Principal Investigator: Tae-Yop Kim, MD, PhD Konkuk University

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Responsible Party: Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical Center Identifier: NCT01693185    
Other Study ID Numbers: KUH1160048
First Posted: September 26, 2012    Key Record Dates
Results First Posted: June 18, 2014
Last Update Posted: June 18, 2014
Last Verified: May 2014
Keywords provided by Tae-Yop Kim, MD PhD, Konkuk University Medical Center:
Additional relevant MeSH terms:
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Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents