Accessing the Driving Skills After the Endoscopy of Intravenous Anesthesia by Driving Simulator

Not Applicable

Completed

• Conditions: Driving
• Interventions: Procedure: Endoscopy of Intravenous Anesthesia; Device: Driving Simulator; Drug: Propofol

• Registration Number: NCT02280148
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

The purpose of this study is to assess the driving and cognitive ability of gastrointestinal endoscopy patients at different time points after intravenous anesthesia (propofol for example), and to explore whether the driving and cognitive ability have a relationship with the blood concentration of propofol or not.

Detailed Description

20-70 year-old volunteers who hold legitimate licenses were recruited to have gastroscopy or colonoscopy under intravenous anesthesia with propofol, and before endoscopy using driving simulator and NCT to measure patients' driving ability and cognitive function as a baseline, in the same way, assessing patients' driving ability and cognitive function after 2h, 4h of the endoscopy , meantime collecting blood samples and separating blood plasma, using HPLC (High Performance Liquid Chromatography) to measure blood concentration of propofol.

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-10
• Study First Submitted: 2014-10-25
• Study First Submitted QC: 2014-10-30
• Last Update Submitted: 2014-10-30
• Study First Posted: 2014-10-31
• Last Update Posted: 2014-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Outpatients who held a valid driver's license,were Aged 20 to 70 years old,had more than 2 years of driving experience, were with endoscopy or colonoscopy indications.

Exclusion Criteria

with gastroscopy or colonoscopy contraindications, long-term use of benzodiazepines or opioids,an American Society of Anesthesiologists physical status score (ASA) of Class IV or V,pregnant women,Emergency and hospitalized patients, allergy to narcotic drugs, with acute and chronic liver injury, have any clinical evidence of hepatic encephalopathy,severe based diseases and mental illness,serious adverse reactions such as dizziness, nausea, and vomiting in simulated driving.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopy of Intravenous Anesthesia	Endoscopy of Intravenous Anesthesia	20-70 year-old volunteers who hold legitimate licenses were recruited to have gastroscopy or colonoscopy under intravenous anesthesia with propofol
Endoscopy of Intravenous Anesthesia	Driving Simulator	20-70 year-old volunteers who hold legitimate licenses were recruited to have gastroscopy or colonoscopy under intravenous anesthesia with propofol
Endoscopy of Intravenous Anesthesia	Propofol	20-70 year-old volunteers who hold legitimate licenses were recruited to have gastroscopy or colonoscopy under intravenous anesthesia with propofol

Primary Outcome Measures

Name	Time	Method
driving ability after of the endoscopy under Intravenous Anesthesia	within the first 4h after endoscopy	before endoscopy using driving simulator to measure patients' driving ability as a baseline, in the same way, assessing patients' driving ability after 2h, 4h of the endoscopy.Driving simulation design scenes concluded low risk driving scene, medium risk driving scene and high risk driving scene.For low risk driving scene ,the observed indicators were average speed(m/s),average acceleration (m/s2), the average lane deviation (m), the maximum lane shift (m), the times of deviating from pathway .For medium risk driving scene ,the observed indicators were the minimum distance from overtaken vehicle, the times of overtaking intentions were observed in 80km/h and 40km/h speed limit.For high risk driving scene ,the observed indicators were maximum acceleration or deceleration, braking reaction time or accelerating reaction time.

Secondary Outcome Measures

Name	Time	Method
cognitive function after of the endoscopy under Intravenous Anesthesia	within the first 4h after endoscopy	before endoscopy using NCT to measure patients'cognitive function as a baseline, in the same way, assessing patients'cognitive function after 2h, 4h of the endoscopy.common methods for assessing patients' cognitive function include MoCA Rating Scale (Montreal assessment)、MMSE (Mini-Mental State score), due to the poor reproducibility,neither of them were selected. NCT is usually used to diagnose and assess the progress of subclinical hepatic encephalopathy, this test is simple, reproducible, widely used to assess psychomotor functions recovery after anesthesia . NCT includes part A and B, in order to simplify ,only part A was used for the study.NCT-A requires participants line 1-25 numbers which were randomly distributed on paper in ascending order in time as short as possible, and their finish time will be recorded.

Trial Locations

Locations (1)

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China