Anesthesia, Recovery
Conditions
Keywords
Colonoscopy, EGD, Sedation, procedural sequence
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.
Interventions
OTHERColonoscopy followed by EGD
Colonoscopy is done first followed by EGD
OTHEREGD followed by Colonoscopy
Esophagoduodenoscopy (EGD) is done first followed by Colonoscopy
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to discharge | 1 hour | Time from end of procedures to patient discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Propofol dose | 1 hour | Propofol sedation requirements |
| 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. |
| Cognitive impairment | 24 hours | An assessment of cognitive impairment after the subject emerges from sedation, using the Modified Post Anesthesia Discharge System (M-PADS) |
| Adverse events during sedation | 1 hour | apnea, desaturations, hypotension, bradycardia and other hemodynamical disturbances during sedation |
Countries
Lebanon
Contacts
Primary ContactAla I Sharara, MD
Outcome results
None listed