Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First (RECoVER)

RECoVER: Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First

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

Study Overview

• Status: Unknown
• Conditions: Anesthesia, Recovery
• Intervention / Treatment: Other: EGD followed by Colonoscopy; Other: Colonoscopy followed by EGD

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Recruiting
    • American University of Beirut - Medical Center
    • Contact: Ala' I. Sharara, MD; Phone Number: 5345 009611350000; Email: as08@aub.edu.lb
    • Principal Investigator: Ala' I Sharara, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age above 18
• Scheduled EGD and colonoscopy on the same day
• Scheduled to Anaesthesiologist administered sedation during the procedure

Exclusion Criteria:

• 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
• Having a stoma
• Compromised swallowing reflex or mental status
• Prior colon resection or gastric surgery
• Age above 75 years
• Chronic use of more than 1 psychoactive drug (Benzodiazepines, Tricyclic antidepressants, antipsychotics, selective serotonin receptor inhibitors, serotonin norepinephrine receptor inhibitors, Monoamine oxidase inhibitor)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EGD followed by Colonoscopy; Randomized to group Esophagogastroduodenoscopy followed by Colonoscopy	Other: EGD followed by Colonoscopy; Esophagoduodenoscopy (EGD) is done first followed by Colonoscopy
Active Comparator: Colonoscopy followed by EGD; Randomized to group Colonoscopy followed by Esophagogastroduodenoscopy	Other: Colonoscopy followed by EGD; Colonoscopy is done first followed by EGD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to discharge	Time from end of procedures to patient discharge	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Propofol dose	Propofol sedation requirements	1 hour
Depth of anesthesia	Bispectral Index (BIS) tracking of depth of anesthesia throughout the two procedures. BIS is a single dimensionless number generated by EEG analysis.	1 hour
Cognitive impairment	An assessment of cognitive impairment after the subject emerges from sedation, using the Modified Post Anesthesia Discharge System (M-PADS)	24 hours
Adverse events during sedation	apnea, desaturations, hypotension, bradycardia and other hemodynamical disturbances during sedation	1 hour

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Ala I Sharara, MD, American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2019
• Primary Completion (Anticipated): January 30, 2020
• Study Completion (Anticipated): January 30, 2020

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: EGD; Colonoscopy; Sedation; procedural sequence
• Other Study ID Numbers: BIO-2018-0629

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No