Anesthesia, Recovery Clinical Trial
— RECoVEROfficial title:
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
Status | Recruiting |
Enrollment | 120 |
Est. completion date | January 30, 2020 |
Est. primary completion date | January 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Lebanon | American University of Beirut - Medical Center | Beirut |
Lead Sponsor | Collaborator |
---|---|
American University of Beirut Medical Center |
Lebanon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to discharge | Time from end of procedures to patient discharge | 1 hour | |
Secondary | Propofol dose | Propofol sedation requirements | 1 hour | |
Secondary | 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 | |
Secondary | Cognitive impairment | An assessment of cognitive impairment after the subject emerges from sedation, using the Modified Post Anesthesia Discharge System (M-PADS) | 24 hours | |
Secondary | Adverse events during sedation | apnea, desaturations, hypotension, bradycardia and other hemodynamical disturbances during sedation | 1 hour |