Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First

Study Overview
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Brief Summary
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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: Colonoscopy followed by Esophagogastroduodenoscopy (EGD) EGD followed by Colonoscopy

Detailed Description
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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.

Official Title
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RECoVER: Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First

Conditions
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Anesthesia, Recovery

Intervention / Treatment
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* Other: Colonoscopy followed by EGD
* Other: EGD followed by Colonoscopy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EGD followed by Colonoscopy<br>Randomized to group Esophagogastroduodenoscopy followed by Colonoscopy | Other: EGD followed by Colonoscopy<br>* Esophagoduodenoscopy (EGD) is done first followed by Colonoscopy<br>|
| Active Comparator: Colonoscopy followed by EGD<br>Randomized to group Colonoscopy followed by Esophagogastroduodenoscopy | Other: Colonoscopy followed by EGD<br>* Colonoscopy is done first followed by EGD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to discharge | Time from end of procedures to patient discharge | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, EGD, Sedation, procedural sequence