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

Driving Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280148
• Other study ID #: BJFH-EC/2013-073
• Status: Completed
• Phase: N/A
• First received: October 25, 2014
• Last updated: October 30, 2014
• Start date: November 2013
• Est. completion date: March 2014

Study information

• Verified date: October 2014
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Driving

Intervention

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

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Riphaus A, Gstettenbauer T, Frenz MB, Wehrmann T. Quality of psychomotor recovery after propofol sedation for routine endoscopy: a randomized and controlled study. Endoscopy. 2006 Jul;38(7):677-83. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	measure blood concentration of propofol	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.	within the first 4h after endoscopy	No
Primary	driving ability after of the endoscopy under Intravenous Anesthesia	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.	within the first 4h after endoscopy	Yes
Secondary	cognitive function after of the endoscopy under Intravenous Anesthesia	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.	within the first 4h after endoscopy	Yes