Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First

American University of Beirut Medical Center120 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

120

Conditions

Anesthesia, Recovery

Interventions

Colonoscopy followed by EGDOTHER

Colonoscopy is done first followed by EGD

EGD followed by ColonoscopyOTHER

Esophagoduodenoscopy (EGD) is done first followed by Colonoscopy

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

American University of Beirut - Medical Center

Beirut, Lebanon

RECRUITING

Outcomes

Primary Outcomes

Time to discharge

Time from end of procedures to patient discharge

Time frame: 1 hour

Secondary Outcomes

Propofol dose

Propofol sedation requirements

Time frame: 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.

Time frame: 1 hour

Cognitive impairment

An assessment of cognitive impairment after the subject emerges from sedation, using the Modified Post Anesthesia Discharge System (M-PADS)

Time frame: 24 hours

Adverse events during sedation

apnea, desaturations, hypotension, bradycardia and other hemodynamical disturbances during sedation

Time frame: 1 hour

Central Contacts

Ala I Sharara, MD

CONTACT

+961-1-350000 as08@aub.edu.lb

Data from ClinicalTrials.gov

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