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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01693185
First Posted: September 26, 2012
Last Update Posted: June 18, 2014
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.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Tae-Yop Kim, MD PhD, Konkuk University Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Tae-Yop Kim, MD PhD, Konkuk University Medical Center:

Primary Outcome Measures:
  • 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:
  • 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.

  • Bispectra Lindex Score [ Time Frame: every 5 min during and after colonoscopy ]
    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 ]
    patients' distress in visual analogue scale 100 mm minimal distress=0, maximal distress=100

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

  • Indigence of Patient's Recall [ Time Frame: after colonoscopy ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 17, 2012
First Posted: September 26, 2012
Results First Submitted: February 2, 2014
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:
colonoscopy
remifentanil
midazolam
meperidine

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


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