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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Tae-Yop Kim, MD PhD, Konkuk University Medical Center
ClinicalTrials.gov Identifier:
NCT01693185
First received: September 17, 2012
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Diagnostic Colonoscopy Screening
Drug: Remifentanil
Drug: Midazolam
Drug: Meperidine
Drug: placebo (for remifentanil)
Drug: placebo (for midazolam)
Drug: placebo (for meperidine)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Remifentanil Only vs. Combination Group Midazolam + Meperidine During Elective Colonoscopy

Resource links provided by NLM:


Further study details as provided by Konkuk University Medical Center:

Primary Outcome Measures:
  • The Recovery Time [ Time Frame: every 5 minutes after completing colonoscopy up to 30 min ] [ Designated as safety issue: No ]

    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:
  • Participants Assumed to Feel Frequent Pain [ Time Frame: during and after colonoscopy ] [ Designated as safety issue: No ]
    patients sound "Ah" at feeling pain during colonosocpy: if a patients sounds "Ah" > 6 times, the patient was assumed to feel frequent pain.

  • Bispectra Lindex Score [ Time Frame: every 5 min during and after colonoscopy ] [ Designated as safety issue: No ]
    Bispectral index (BIS) score 0-100 maximal sedation=0, maximal sedation=100

  • Patient's Distress Score [ Time Frame: 5 min after the end of colonoscopy ] [ Designated as safety issue: No ]
    patients' distress in visual analogue scale 100 mm minimal distress=0, maximal distress=100

  • Endoscopist Satisfaction [ Time Frame: 5 min after the colonoscopy ] [ Designated as safety issue: No ]
    endoscopist's satisfaction after colonoscopy in visual analogue scale 100 mm

  • Indigence of Patient's Recall [ Time Frame: after colonoscopy ] [ Designated as safety issue: No ]
    The numbers of patients who recalled instructions and explanations given during colonoscopy


Enrollment: 60
Study Start Date: December 2012
Study Completion Date: August 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693185

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

No publications provided

Responsible Party: Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT01693185     History of Changes
Other Study ID Numbers: KUH1160048
Study First Received: September 17, 2012
Results First Received: February 2, 2014
Last Updated: May 16, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Konkuk University Medical Center:
colonoscopy
remifentanil
midazolam
meperidine

Additional relevant MeSH terms:
Meperidine
Remifentanil
Midazolam
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Adjuvants, Anesthesia
Narcotics
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014