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

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ClinicalTrials.gov Identifier: NCT02280148
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : October 31, 2014
Sponsor:
Information provided by (Responsible Party):
Zhan yuanlin, 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.

Condition or disease Intervention/treatment Phase
Driving Procedure: Endoscopy of Intravenous Anesthesia Device: Driving Simulator Drug: Propofol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : November 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
Drug Information available for: Propofol

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




Primary Outcome Measures :
  1. driving ability after of the endoscopy under Intravenous Anesthesia [ Time Frame: 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 :
  1. cognitive function after of the endoscopy under Intravenous Anesthesia [ Time Frame: 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:
  1. measure blood concentration of propofol [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280148


Locations
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China, Beijing
Beijing Friendship Hospital
Beijing, Beijing, China, 100000
Sponsors and Collaborators
Beijing Friendship Hospital
Investigators
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Study Chair: peng Li, doctor Beijing Friendship Hospital
Publications:
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Responsible Party: Zhan yuanlin, Master of Beijing Friendship Hospital Gastroenterology, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT02280148    
Other Study ID Numbers: BJFH-EC/2013-073
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: October 31, 2014
Last Verified: October 2014
Keywords provided by Zhan yuanlin, Beijing Friendship Hospital:
Propofol
gastroscopy and colonoscopy
driving simulator
driving ability
cognitive function
patients
Additional relevant MeSH terms:
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Propofol
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General