Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First (RECoVER)

American University of Beirut Medical Center

Status: Unknown

Conditions: Anesthesia, Recovery

Treatments: Other: EGD followed by Colonoscopy; Other: Colonoscopy followed by EGD

Study type: Interventional

Funder types: Other

Identifiers

NCT04096339

BIO-2018-0629

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

EGD followed by Colonoscopy

Active Comparator group

Description:

Randomized to group Esophagogastroduodenoscopy followed by Colonoscopy

Treatment:

Other: EGD followed by Colonoscopy

Colonoscopy followed by EGD

Active Comparator group

Description:

Randomized to group Colonoscopy followed by Esophagogastroduodenoscopy

Treatment:

Other: Colonoscopy followed by EGD