Sedation Regimens in GI Endoscopy

Status Completed

Clinical Trial Summary

This is a noninferiority study designed to examine whether conscious sedation with midazolam alone results in efficacy and safety that is not inferior to the combination of midazolam and fentanyl. English-speaking patients ≥18 years old and ≤75 years old presenting for GI endoscopy planned with conscious sedation using midazolam and fentanyl, will be randomized 1:1 to single agent sedation with midazolam or combination sedation with midazolam and fentanyl. Participants will be blinded to the choice of sedation. Sedation quality and adverse events will be measured with a validated patient-centered measure of procedural sedation quality, the PROcedural Sedation Assessment Survey (PROSAS) [Leffler, et al. Gastrointest Endosc. 2015;81(1):194-203]. Endoscopic quality measures in the 2 study groups will be collected by retrospective chart review, as an additional metric to ensure the quality of the procedure is not compromised by the choice of sedation.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04807101
Study type	Interventional
Source	Greg S Cohen MD LLC
Contact
Status	Completed
Phase	Early Phase 1
Start date	April 5, 2021
Completion date	July 10, 2023

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04580030` - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Active, not recruiting	`NCT04279054` - Decreased Neuraxial Morphine After Cesarean Delivery	Early Phase 1
Completed	`NCT03640442` - Modified Ramped Position for Intubation of Obese Females.	N/A
Recruiting	`NCT04099693` - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated	`NCT02481999` - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed	`NCT04235894` - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting	`NCT05525104` - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen).	N/A
Recruiting	`NCT05024084` - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth	Phase 4
Completed	`NCT04204785` - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions	N/A
Completed	`NCT03277872` - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope	N/A
Terminated	`NCT03940651` - Cardiac and Renal Biomarkers in Arthroplasty Surgery	Phase 4
Terminated	`NCT02529696` - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed	`NCT05346588` - THRIVE Feasibility Trial	Phase 3
Terminated	`NCT03704285` - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting	`NCT05259787` - EP Intravenous Anesthesia in Hysteroscopy	Phase 4
Completed	`NCT02894996` - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient?	N/A
Completed	`NCT05386082` - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated	`NCT03567928` - Laryngeal Mask in Upper Gastrointestinal Procedures	N/A
Recruiting	`NCT06074471` - Motor Sparing Supraclavicular Block	N/A
Completed	`NCT04163848` - CARbon Impact of aNesthesic Gas