Remifentanil Only vs. Midazolam and Meperidine During Elective Colonoscopy

NCT01693185 | Completed Phase 4 Results

• 1 other identifier: KUH1160048
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Diagnostic Colonoscopy Screening

Keywords

colonoscopy; remifentanil; midazolam; meperidine

Outcome Measures

Primary Outcomes (1)

• The Recovery Time

  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.

  every 5 minutes after completing colonoscopy up to 30 min

Secondary Outcomes (5)

• Participants Assumed to Feel Frequent Pain

  during and after colonoscopy

• Bispectra Lindex Score

  every 5 min during and after colonoscopy

• Patient's Distress Score

  5 min after the end of colonoscopy

• Endoscopist Satisfaction

  5 min after the colonoscopy

• Indigence of Patient's Recall

  after colonoscopy

Study Arms (2)

Remifentanil

EXPERIMENTAL

remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)

Drug: Remifentanil; Drug: placebo (for midazolam); Drug: placebo (for meperidine)

midazolam and meperidine

ACTIVE COMPARATOR

a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)

Drug: Midazolam; Drug: Meperidine; Drug: placebo (for remifentanil)

Interventions

Remifentanil DRUG

continuous infusion 0.4 mcg/kg/min

Also known as: Ultiva

Remifentanil

Midazolam DRUG

bolus injection

Also known as: dormicum

midazolam and meperidine

Meperidine DRUG

bolus injection for 30 sec 1.0 mg/kg

Also known as: Pethidine Injection

midazolam and meperidine

placebo (for remifentanil) DRUG

normal saline mimic diluted remifentanil

Also known as: normal saline

midazolam and meperidine

placebo (for midazolam) DRUG

normal saline mimic to midazolam injection

Also known as: normal saline

Remifentanil

placebo (for meperidine) DRUG

normal saline mimic meperidine injection

Also known as: normal saline

Remifentanil

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Konkuk University Medical Center: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Konkuk University Medical Center

Seoul, Seoul, 143-729, South Korea

Location

MeSH Terms

Interventions

Remifentanil; Midazolam; Meperidine; Saline Solution

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Isonipecotic Acids; Acids, Heterocyclic; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Tae-Yop Kim, Professor of Anesthesiology
• Organization: Konkuk University Medical Center

taeyop@gmail.com

82-2-2030-5445

Study Officials

• Tae-Yop Kim, MD, PhD

  Konkuk University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 26, 2012
• Study Start: December 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 18, 2014
• Results First Posted: June 18, 2014

Record last verified: 2014-05

Locations

KR (1)