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

NCT ID: NCT02280148

Last Updated: 2014-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Driving

Keywords

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Propofol gastroscopy and colonoscopy driving simulator driving ability cognitive function patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Endoscopy of Intravenous Anesthesia

Intervention Type PROCEDURE

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.

Driving Simulator

Intervention Type DEVICE

Propofol

Intervention Type DRUG

2mg / kg

Interventions

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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.

Intervention Type PROCEDURE

Driving Simulator

Intervention Type DEVICE

Propofol

2mg / kg

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhan yuanlin

Master of Beijing Friendship Hospital Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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peng Li, doctor

Role: STUDY_CHAIR

Beijing Friendship Hospital

Locations

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Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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. doi: 10.1055/s-2006-925244.

Reference Type BACKGROUND
PMID: 16810592 (View on PubMed)

Hao XW, Zhan YL, Li P, Zhang ST, Yan XD, Li XM, Xiang W. Recovery of driving skills after endoscopy under propofol sedation: a prospective pilot study to assess the driving skills after endoscopic sedation using driving simulation. BMC Anesthesiol. 2023 Jun 24;23(1):223. doi: 10.1186/s12871-023-02122-z.

Reference Type DERIVED
PMID: 37355565 (View on PubMed)

Other Identifiers

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BJFH-EC/2013-073

Identifier Type: -

Identifier Source: org_study_id