Moderate Sedation for Elective Upper Endoscopy With Balanced Propofol Versus Propofol Alone: a Randomized Clinical Trial
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 7, 2013
CompletedFirst Submitted
Initial submission to the registry
June 23, 2014
CompletedFirst Posted
Study publicly available on registry
June 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2015
CompletedJanuary 25, 2017
January 1, 2017
2.1 years
June 23, 2014
January 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
visual analog scale
The patient satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone
Within the 24 hours after EGD
Secondary Outcomes (1)
complications rates
Within the 1 hour after EGD
Other Outcomes (3)
complications rates
Within the 1 hour after EGD
total dose of the sedation drugs
Within the 1 hour after EGD
visual analog scale
Within the 1 hour after EGD
Study Arms (2)
balanced propofol group
EXPERIMENTALpropofol alone group
ACTIVE COMPARATORInterventions
Midazolam and propofol are used for sedation drug. Balanced propofol sedation (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol.
Eligibility Criteria
You may qualify if:
- over 19 years old, male and female
- patients who have plan to get esophagogastroduodenoscopy (EGD)
You may not qualify if:
- ASA class III or IV
- Allergies to propofol, sulfites or eggs
- patients who had surgery for esophagus, stomach or duodenum
- inpatients
- patients who had sleep apnea, gastroparesis or achalasia
- patients who are taking sedative drugs more than 6 months
- pregnancy
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonsei university College of Medicine
Seoul, Seoul, 120-752, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2014
First Posted
June 25, 2014
Study Start
January 7, 2013
Primary Completion
February 4, 2015
Study Completion
February 4, 2015
Last Updated
January 25, 2017
Record last verified: 2017-01