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

Sponsor

Beijing Friendship Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02280148

Collaborator

(none)

Enrollment

Location

Arm

3.9

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Driving	Procedure: Endoscopy of Intravenous Anesthesia Device: Driving Simulator Drug: Propofol	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Procedure: Endoscopy of Intravenous Anesthesia The dose of intravenous anesthesia drug and time was controlled by the anesthesiologist,endoscopists were responsible for gastroscopy or colonoscopy , nurses assisted endoscopists with biopsy.Each subject's initial dose of propofol were set at 2mg / kg, and were added properly by anesthesiologists additional according to the subjects' intraoperative sedation or surgical time. Device: Driving Simulator Drug: Propofol 2mg / kg

Arm

Intervention/Treatment

Experimental: 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

Procedure: Endoscopy of Intravenous Anesthesia

The dose of intravenous anesthesia drug and time was controlled by the anesthesiologist,endoscopists were responsible for gastroscopy or colonoscopy , nurses assisted endoscopists with biopsy.Each subject's initial dose of propofol were set at 2mg / kg, and were added properly by anesthesiologists additional according to the subjects' intraoperative sedation or surgical time.

Device: Driving Simulator

Drug: Propofol

2mg / kg

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

measure blood concentration of propofol [within the first 4h after endoscopy]
collecting blood samples and separating blood plasma, using HPLC (High Performance Liquid Chromatography) to measure blood concentration of propofol after 2h,4h of endoscopy. Propofol blood concentration was measured by high performance liquid chromatography, which included high-performance liquid chromatography, C18 column, vortex mixer, high-speed centrifuges, reference reagents including propofol, thymol (internal standard) , methanol, acetonitrile, purified water, blank plasma. Measurement procedure can be summarized as the internal standard and plasma processing, the configuration of standard chromatographic conditions, HPLC analysis, the provision of the standard curve. The method detection limit was 0.5μg / ml, the scope of application of the linear concentration detection 0.5-4.0μg / ml. Determination of propofol blood concentration was done by researcher of Beijing Friendship Hospital drug testing experiment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.