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

Yonsei University1 site in 1 country22 target enrollmentJanuary 7, 2013

ConditionsEGD Procedure

InterventionsMidazolam + propofol propofol

DrugsMidazolam + propofol propofol

Overview

Phase: Not Applicable
Intervention: Midazolam + propofol
Conditions: EGD Procedure
Sponsor: Yonsei University
Enrollment: 22
Locations: 1
Primary Endpoint: visual analog scale
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 7, 2013

End Date

February 4, 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yonsei University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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