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

EGD Procedure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174588
• Other study ID #: 4-2012-0801
• Status: Completed
• Phase: N/A
• First received: June 23, 2014
• Last updated: January 23, 2017
• Start date: January 7, 2013
• Est. completion date: February 4, 2015

Study information

• Verified date: January 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 4, 2015
• Est. primary completion date: February 4, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• EGD Procedure

Intervention

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.
• propofol
propofol are used for sedation drug

Locations

Country	Name	City	State
Korea, Republic of	Yonsei university College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	complications rates	The safety after EGD following balanced propofol sedation versus propofol sedation alone	Within the 1 hour after EGD
Other	total dose of the sedation drugs	The economy after EGD following balanced propofol sedation versus propofol sedation alone	Within the 1 hour after EGD
Other	visual analog scale	The endoscopist's satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone	Within the 1 hour after EGD
Primary	visual analog scale	The patient satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone	Within the 24 hours after EGD
Secondary	complications rates	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