Moderate Sedation for Elective Upper Endoscopy With Balanced Propofol Versus Propofol Alone: a Randomized Clinical Trial

January 23, 2017 updated by: Yonsei University
Since introduction in 1989, propofol has gained wide acceptance for sedation during endoscopic procedures. The optimal sedation drug during esophagogastroendoscopy (EGD) is not established. Midazolam and propofol are used for sedation drug. Balanced propofol sedation (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol. In this study, the investigators want to compare the patient satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. over 19 years old, male and female
  2. patients who have plan to get esophagogastroduodenoscopy (EGD)

Exclusion Criteria:

  1. ASA class III or IV
  2. Allergies to propofol, sulfites or eggs
  3. patients who had surgery for esophagus, stomach or duodenum
  4. inpatients
  5. patients who had sleep apnea, gastroparesis or achalasia
  6. patients who are taking sedative drugs more than 6 months
  7. pregnancy
  8. hypotension (systolic pressure less than 90mmHg), bradycardia (pulse rates less than 50 times per minute) or hypoxia (SpO2 less than 90%)
  9. psychiatric or neurologic problems (ex. epilepsy or dementia)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: balanced propofol group
Drug: Midazolam + propofol
Midazolam and propofol are used for sedation drug. Balanced propofol sedation (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol.
Active Comparator: propofol alone group
Drug: propofol
propofol are used for sedation drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analog scale
Time Frame: Within the 24 hours after EGD
The patient satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone
Within the 24 hours after EGD

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications rates
Time Frame: Within the 1 hour after EGD
The recovery time after EGD following balanced propofol sedation versus propofol sedation alone. The safety after EGD following balanced propofol sedation versus propofol sedation alone
Within the 1 hour after EGD

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications rates
Time Frame: Within the 1 hour after EGD
The safety after EGD following balanced propofol sedation versus propofol sedation alone
Within the 1 hour after EGD
total dose of the sedation drugs
Time Frame: Within the 1 hour after EGD
The economy after EGD following balanced propofol sedation versus propofol sedation alone
Within the 1 hour after EGD
visual analog scale
Time Frame: Within the 1 hour after EGD
The endoscopist's satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone
Within the 1 hour after EGD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2013

Primary Completion (Actual)

February 4, 2015

Study Completion (Actual)

February 4, 2015

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

June 24, 2014

First Posted (Estimate)

June 25, 2014

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2012-0801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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