Driving Skills Recovery Following Procedural Sedation for Gastrointestinal Endoscopy

May 16, 2023 updated by: John Vargo, The Cleveland Clinic

Driving Skills Recovery Following Procedural Sedation for Gastrointestinal Endoscopy: A Prospective Cohort Study

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.

Study Overview

Status

Terminated

Detailed Description

Procedural sedation for ambulatory endoscopy procedures is delivered millions of times per year in the United States. Current standard of care necessitates the presence of a responsible adult to take the patient from the endoscopic facility back home and to observe the patient. In addition, patients are frequently advised not to drive until the morning after the procedure. This recommendation holds true whether the procedure was performed in the morning or afternoon. Current data regarding psychomotoric recovery following procedural sedation for gastrointestinal endoscopy is quite limited. Moreover there are no data utilizing a driving simulator to gauge psychomotoric recovery in this setting.

The proposed study is a prospective, open label cohort study enrolling patients at the Cleveland Clinic's advanced endoscopy unit.

Inclusion criteria are: English speaking patients 18 years or older who currently hold a valid driver's license, are able to give informed consent and are undergoing either anesthesiologist directed propofol sedation (Group1) or a combination of an opioid and benzodiazepine targeting moderate sedation (Group 2) for elective outpatient procedures including advanced (endoscopic retrograde cholangiopancreatography, endoscopic ultrasonography, endoscopic submucosal dissection, deep enteroscopy) and non-advanced (esophagogastroduodenoscopy, colonoscopy) procedures.

Exclusion criteria include: inpatients, patients with altered mental status, legal blindness, physical limitations that would not make them candidates to be tested in the driving simulator, American Society of Anesthesiologists (ASA) ≥ 4 , urgent procedures, systolic hypotension defined as a systolic blood pressure < 90 mmHg and patients in whom English is not the primary language.

Upon enrollment the following information will be obtained: Age, gender, BMI, intended procedure, Mallampati score, medications and allergies, comorbidities (obesity, history of cardiac disease, renal insufficiency, chronic obstructive pulmonary disease, obstructive sleep apnea, diabetes mellitus, and the use of medications narcotics, antidepressants and sedatives.

Upon enrollment, the patient will undergo a 5-10 minute training session on a commercially available driving simulator. Following this, the subjects will complete a 5 minute standardized driving simulation. The subjects will then undergo their scheduled procedure.

Procedural data that will be obtained will include the type and doses of sedatives/analgesics utilized, procedure type, procedure length, use of any reversal agents or airway devices such as oropharyngeal or nasopharyngeal airways. In addition the occurrence of any intraprocedural cardiopulmonary unintended events such as hypotension, bradycardia and apnea will also be recorded.

Once the patient arrives in the recovery unit, they will be assessed every 5 minutes utilizing the observers scale for sedation and alertness (OAS). Discharge criteria would include; An OAS score of 5 (responding readily to name, with no evidence for ptosis; blood pressure and heart rate within 20% of baseline, oxygen saturation greater than 90% while breathing room air, the ability to walk without instability and the ability to drink liquids). The time from completion of the procedure to reaching the discharge criteria will be noted. At the time of reaching the discharge threshold, a repeat driving simulation will be performed utilizing the same program.

Simulator outcome variables will be analyzed by both parametric and nonparametric statistics. The variables that will be analyzed include: number of off road crashes, number of collisions with vehicles and other roadway objects, number of times over the posted speed limit, percentage of time over the posted limit, total number of times the center line was crossed, total number of times the driver went off the road, percentage of time out of lanes, overall turn signal usage, minimum distance to vehicles in drivers pedal reaction time. In addition, a summation of overall driving errors will be obtained.

An analysis comparing baseline and recovery driving simulator data within each sedation arm (anesthesiologist administered propofol or endoscopist directed opioid/benzodiazepine) will be performed. In a addition for each sedation arm, a univariate and multivariate analysis will be performed to evaluate for factors associated with delayed recovery of driving simulator performance.

Study Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: John J Vargo, MD, MPH
  • Phone Number: (216)445-5012
  • Email: vargoj@ccf.org

Study Contact Backup

  • Name: Pooja Lal, MD
  • Phone Number: (216)445-5012
  • Email: lalp@ccf.org

Study Locations

    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median number of summated deviations
Time Frame: From end of procedure until discharge, typically less than 4 hours
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
Time Frame: From end of procedure until discharge, typically less than 4 hours
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).
Time Frame: From end of procedure until discharge, typically less than 4 hours
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)
Time Frame: From end of procedure until discharge, typically less than 4 hours
Simulator Results - Mean brake pedal reaction time (seconds) during simulated driving scenario
From end of procedure until discharge, typically less than 4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: At baseline
Years, (mean), Group 1 versus Group 2
At baseline
Body mass index
Time Frame: At baseline
kg/m2, (mean) Group 1 versus group 2
At baseline
Mallampati score
Time Frame: At baseline
median, Group 1 versus Group 2
At baseline
Total propofol dose
Time Frame: From beginning to end of endoscopy, typically less than 2 hours
mean,(mg/kg)
From beginning to end of endoscopy, typically less than 2 hours
Total midazolam dose
Time Frame: From beginning to end of endoscopy, typically less than 2 hours
mean, (mg/kg)
From beginning to end of endoscopy, typically less than 2 hours
Total fentanyl dose
Time Frame: From beginning to end of endoscopy, typically less than 2 hours
mean, (micrograms / kg)
From beginning to end of endoscopy, typically less than 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: John J Vargo, MD, MPH, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2019

Primary Completion (Actual)

March 12, 2020

Study Completion (Actual)

March 12, 2020

Study Registration Dates

First Submitted

October 24, 2019

First Submitted That Met QC Criteria

April 16, 2020

First Posted (Actual)

April 17, 2020

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon study completion, it is anticipated that the results will be submitted for publication in a peer reviewed journal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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