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

Not Applicable

Completed

• Conditions: EGD Procedure
• Interventions: Drug: Midazolam + propofol; Drug: propofol

• Registration Number: NCT02174588
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-07
• Study First Submitted: 2014-06-23
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-25
• Primary Completion: 2015-02-04
• Study Completion: 2015-02-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
balanced propofol group	Midazolam + propofol	-
propofol alone group	propofol	-

Primary Outcome Measures

Name	Time	Method
visual analog scale	Within the 24 hours after EGD	The patient satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone

Secondary Outcome Measures

Name	Time	Method
complications rates	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

Trial Locations

Locations (1)

Yonsei university College of Medicine; 🇰🇷 Seoul, Korea, Republic of