Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First
- Conditions
- Anesthesia, Recovery
- Interventions
- Other: EGD followed by ColonoscopyOther: Colonoscopy followed by EGD
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- Age above 18
- Scheduled EGD and colonoscopy on the same day
- Scheduled to Anaesthesiologist administered sedation during the procedure
- 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
- Arm && Interventions
Group Intervention Description EGD followed by Colonoscopy EGD followed by Colonoscopy Randomized to group Esophagogastroduodenoscopy followed by Colonoscopy Colonoscopy followed by EGD Colonoscopy followed by EGD Randomized to group Colonoscopy followed by Esophagogastroduodenoscopy
- 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