Clinical trial NCT04096339: Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First
Official title: RECoVER: Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, Recovery
Keywords: Colonoscopy
EGD
Sedation
procedural sequence
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Time to discharge
timeFrame: 1 hour
Secondary outcomes:
measure: Propofol dose
timeFrame: 1 hour
measure: Depth of anesthesia
timeFrame: 1 hour
measure: Cognitive impairment
timeFrame: 24 hours
measure: Adverse events during sedation
timeFrame: 1 hour
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut - Medical Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Ala I Sharara, MD
role: PRINCIPAL_INVESTIGATOR
References: