Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First
RECoVER
RECoVER: Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First
1 other identifier
interventional
120
1 country
1
Brief Summary
The purpose of this research is to compare the effect of different procedural sequences on the time to recovery and the propofol sedation requirements in patients undergoing bidirectional endoscopy with sedation. The two sequences are:
- Colonoscopy followed by Esophagogastroduodenoscopy (EGD)
- EGD followed by Colonoscopy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Shorter than P25 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
July 3, 2019
CompletedFirst Submitted
Initial submission to the registry
July 11, 2019
CompletedFirst Posted
Study publicly available on registry
September 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2020
CompletedSeptember 19, 2019
September 1, 2019
7 months
July 11, 2019
September 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to discharge
Time from end of procedures to patient discharge
1 hour
Secondary Outcomes (4)
Propofol dose
1 hour
Depth of anesthesia
1 hour
Cognitive impairment
24 hours
Adverse events during sedation
1 hour
Study Arms (2)
EGD followed by Colonoscopy
ACTIVE COMPARATORRandomized to group Esophagogastroduodenoscopy followed by Colonoscopy
Colonoscopy followed by EGD
ACTIVE COMPARATORRandomized to group Colonoscopy followed by Esophagogastroduodenoscopy
Interventions
Colonoscopy is done first followed by EGD
Esophagoduodenoscopy (EGD) is done first followed by Colonoscopy
Eligibility Criteria
You may qualify if:
- Age above 18
- Scheduled EGD and colonoscopy on the same day
- Scheduled to Anaesthesiologist administered sedation during the procedure
You may not qualify if:
- Age below 18
- Known allergy or adverse reaction to Propofol, Midazolam or opioid medication (ex: fentanyl)
- Medical contraindication to Anaesthesia
- Sleep apnea
- American Society of Anesthesiologists classification (ASA) \>3
- Inpatient status
- Pregnant or lactating women
- Known cirrhosis
- Chronic Kidney Disease (stage 4 or 5)
- Known psychological disorder
- Known cognitive dysfunction
- Significant gastroparesis
- Gastric outlet obstruction
- Ileus
- Known or suspected bowel obstruction or perforation
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
American University of Beirut - Medical Center
Beirut, Lebanon
Study Officials
- PRINCIPAL INVESTIGATOR
Ala I Sharara, MD
American University of Beirut Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
July 11, 2019
First Posted
September 19, 2019
Study Start
July 3, 2019
Primary Completion
January 30, 2020
Study Completion
January 30, 2020
Last Updated
September 19, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share