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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGD followed by Colonoscopy | Active Comparator | Randomized to group Esophagogastroduodenoscopy followed by Colonoscopy |
|
| Colonoscopy followed by EGD | Active Comparator | Randomized to group Colonoscopy followed by Esophagogastroduodenoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy followed by EGD | Other | Colonoscopy is done first followed by EGD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to discharge | Time from end of procedures to patient discharge | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Propofol dose | Propofol sedation requirements | 1 hour |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ala I Sharara, MD | Contact | +961-1-350000 | 5345 | as08@aub.edu.lb |
| Name | Affiliation | Role |
|---|---|---|
| Ala I Sharara, MD | American University of Beirut Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American University of Beirut - Medical Center | Recruiting | Beirut | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41646987 | Derived | El Mokahal A, Daher HB, Yamout R, Hoshaimi N, Ayoub C, Shaib Y, Sharara AI. Randomized controlled trial of procedural sequence for same-day bidirectional endoscopy under monitored anesthesia care (RECoVER Trial). IGIE. 2023 Jul 25;2(3):282-291. doi: 10.1016/j.igie.2023.07.014. eCollection 2023 Sep. |
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| EGD followed by Colonoscopy | Other | Esophagoduodenoscopy (EGD) is done first followed by Colonoscopy |
|
| 1 hour |
| Cognitive impairment | An assessment of cognitive impairment after the subject emerges from sedation, using the Modified Post Anesthesia Discharge System (M-PADS) | 24 hours |
| Adverse events during sedation | apnea, desaturations, hypotension, bradycardia and other hemodynamical disturbances during sedation | 1 hour |