Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First

Not Applicable

• Conditions: Anesthesia, Recovery

• Registration Number: NCT04096339
• Lead Sponsor: American University of Beirut Medical Center

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

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 Timeline

• Study Start: 2019-07-03
• Study First Submitted: 2019-07-11
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-18
• Last Update Submitted: 2019-09-18
• Study First Posted: 2019-09-19
• Last Update Posted: 2019-09-19
• Primary Completion: 2020-01-30
• Study Completion: 2020-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to discharge	1 hour	Time from end of procedures to patient discharge

Secondary Outcome Measures

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

Trial Locations

Locations (1)

American University of Beirut - Medical Center; 🇱🇧 Beirut, Lebanon