Driving Skills Recovery Following Procedural Sedation for Gastrointestinal Endoscopy

NCT04350424 | Terminated

• 1 other identifier: IRB 18-1451
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective cohort study that will analyze psychomotoric recovery using a commercially available driving simulator following sedation for endoscopic procedures in subjects undergoing elective outpatient endoscopic procedures. Patients receiving both propofol based sedation and well as those receiving a combination of fentanyl and midazolam will be studied. Baseline data will be obtained after training on the simulator. Following the procedure and after meeting standard discharge criteria, the subjects will undergo the same driving simulation to ascertain psychomotoric recovery.

Conditions

Anesthesia; Psychomotor Status

Keywords

procedural sedation; gastrointestinal endoscopy; deep sedation; moderate sedation; propofol; midazolam; fentanyl

Outcome Measures

Primary Outcomes (4)

• Median number of summated deviations

  Simulator Results - number of off road crashes, number of collisions with vehicles and other roadway objects, number of times over the posted speed limit, total number of times the center line was crossed, total number of times the driver went off the road, number of times turn signal not used or used inappropriately).

  From end of procedure until discharge, typically less than 4 hours

• Center Lane Errors

  Simulator Results - Percentage of time center lane crossed during simulated driving scenario

  From end of procedure until discharge, typically less than 4 hours

• Median minimum distance to vehicle (feet).

  Simulator Results - Median minimum distance to vehicle (feet) during simulated driving scenario

  From end of procedure until discharge, typically less than 4 hours

• Mean brake pedal reaction time (seconds)

  Simulator Results - Mean brake pedal reaction time (seconds) during simulated driving scenario

  From end of procedure until discharge, typically less than 4 hours

Secondary Outcomes (6)

• Age

  At baseline

• Body mass index

  At baseline

• Mallampati score

  At baseline

• Total propofol dose

  From beginning to end of endoscopy, typically less than 2 hours

• Total midazolam dose

  From beginning to end of endoscopy, typically less than 2 hours

Study Arms (2)

Propofol Arm

Outpatients receiving anesthesiologist-administered propofol for elective outpatient endoscopic procedures

Opioid / Benzodiazepine Arm

Outpatients receiving endoscopist-administered opioid / benzodiazepine for elective outpatient endoscopic procedures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ambulatory subjects undergoing a variety of outpatient endoscopic procedures including advanced (ERCP, EUS, ESD, deep enteroscopy) and non-advanced (EGD, colonoscopy) procedures. Prospective, nonrandomized enrollment. Type of sedation is determined by the referring physician and not by study personnel.

You may qualify if:

• English speaking subjects ≥18 years
• Currently hold a valid driver's license
• Able to give informed consent
• Undergoing either anesthesiologist directed propofol sedation targeting deep sedation (Group1) or a combination of an opioid and benzodiazepine targeting moderate sedation (Group 2) for elective outpatient procedures

You may not qualify if:

• Inpatients
• Subjects patients with altered mental status
• Subjects with legal blindness
• Physical limitations that would not make them candidates to be tested in the driving simulator
• American Society of Anesthesiologists physical classification score ≥ 4
• Urgent procedures
• Systolic hypotension defined as a systolic blood pressure ≤ 90 mmHg
• Subjects in whom English is not a primary language.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (2)

• Bajaj JS, Heuman DM, Wade JB, Gibson DP, Saeian K, Wegelin JA, Hafeezullah M, Bell DE, Sterling RK, Stravitz RT, Fuchs M, Luketic V, Sanyal AJ. Rifaximin improves driving simulator performance in a randomized trial of patients with minimal hepatic encephalopathy. Gastroenterology. 2011 Feb;140(2):478-487.e1. doi: 10.1053/j.gastro.2010.08.061. Epub 2010 Sep 21.

  PMID: 20849805 BACKGROUND

• Baskin-Bey ES, Stewart CA, Mitchell MM, Bida JP, Rosenthal TJ, Nyberg SL. Preliminary report of the Hepatic Encephalopathy Assessment Driving Simulator (HEADS) score. Ethn Dis. 2008 Summer;18(3):357-64.

  PMID: 18785452 BACKGROUND

MeSH Terms

Conditions

Status Epilepticus

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John J Vargo, MD, MPH

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: John J. Vargo, MD, MPH; Director Endoscopy Operations, Cleveland Clinic

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: April 17, 2020
• Study Start: March 5, 2019
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)