NCT04096339

Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First

RECoVER: Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: American University of Beirut Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed description

120 patients will be asked to participate in the trial. The subject will undergo both procedures in the order assigned by the randomization sheet. During the procedure, the endoscopist and anesthesiologists will collect data including but not limited to vital signs (heart rate, blood oxygen level, blood pressure) and level of sedation through the Bispectral Index Monitor (BIS). After completing the procedures, the patient will be approached in the recovery room by the study coordinator who will administer the Modified Post Anesthesia Discharge Scoring System (M-PADSS) scale every 5 minutes until a score of 9 or higher is obtained on two consecutive attempts. 24 hours following the procedure, the study coordinator will call the patient in order to assess the patient's cognitive function and drowsiness after they were discharged from the endoscopy unit.

Conditions

• Anesthesia, Recovery

Interventions

Type	Name	Description
OTHER	Colonoscopy followed by EGD	Colonoscopy is done first followed by EGD
OTHER	EGD followed by Colonoscopy	Esophagoduodenoscopy (EGD) is done first followed by Colonoscopy

Timeline

• Start date: 2019-07-03
• Primary completion: 2020-01-30
• Completion: 2020-01-30
• First posted: 2019-09-19
• Last updated: 2019-09-19

Locations

1 site across 1 country: Lebanon