Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First

Last updated: September 18, 2019
Sponsor: American University of Beirut Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04096339
BIO-2018-0629
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age above 18

  • Scheduled EGD and colonoscopy on the same day

  • Scheduled to Anaesthesiologist administered sedation during the procedure

Exclusion

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, Tricyclicantidepressants, antipsychotics, selective serotonin receptor inhibitors, serotoninnorepinephrine receptor inhibitors, Monoamine oxidase inhibitor)

Study Design

Total Participants: 120
Study Start date:
July 03, 2019
Estimated Completion Date:
January 30, 2020

Study 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.

Connect with a study center

  • American University of Beirut - Medical Center

    Beirut,
    Lebanon

    Active - Recruiting

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