Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First

Anesthesia, Recovery Clinical Trial

— RECoVER  

Official title:

RECoVER: Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04096339
• Other study ID #: BIO-2018-0629
• Status: Recruiting
• Phase: N/A
• Start date: July 3, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: September 2019
• Source: American University of Beirut Medical Center
• Contact: Ala I Sharara, MD
• Phone: +961-1-350000
• Email: as08[@]aub.edu.lb
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia, Recovery

Intervention

Other:
• Colonoscopy followed by EGD
Colonoscopy is done first followed by EGD
• EGD followed by Colonoscopy
Esophagoduodenoscopy (EGD) is done first followed by Colonoscopy

Locations

Country	Name	City	State
Lebanon	American University of Beirut - Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to discharge	Time from end of procedures to patient discharge	1 hour
Secondary	Propofol dose	Propofol sedation requirements	1 hour
Secondary	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
Secondary	Cognitive impairment	An assessment of cognitive impairment after the subject emerges from sedation, using the Modified Post Anesthesia Discharge System (M-PADS)	24 hours
Secondary	Adverse events during sedation	apnea, desaturations, hypotension, bradycardia and other hemodynamical disturbances during sedation	1 hour