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

NCT ID: NCT02174588

Last Updated: 2017-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-07

Study Completion Date

2015-02-04

Brief Summary

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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

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Conditions

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EGD Procedure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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balanced propofol group

Group Type EXPERIMENTAL

Midazolam + propofol

Intervention Type DRUG

Midazolam and propofol are used for sedation drug. Balanced propofol sedation (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol.

propofol alone group

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

propofol are used for sedation drug

Interventions

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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.

Intervention Type DRUG

propofol

propofol are used for sedation drug

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yonsei university College of Medicine

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2012-0801

Identifier Type: -

Identifier Source: org_study_id

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