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

NCT02280148 | Completed

• 1 other identifier: BJFH-EC/2013-073
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Driving

Keywords

Propofol; gastroscopy and colonoscopy; driving simulator; driving ability; cognitive function; patients

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• cognitive function after of the endoscopy under Intravenous Anesthesia

  within the first 4h after endoscopy

Other Outcomes (1)

• measure blood concentration of propofol

  within the first 4h after endoscopy

Study Arms (1)

Endoscopy of Intravenous Anesthesia

EXPERIMENTAL

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; Device: Driving Simulator; Drug: Propofol

Interventions

Endoscopy of Intravenous Anesthesia 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.

Endoscopy of Intravenous Anesthesia

Driving Simulator DEVICE

Endoscopy of Intravenous Anesthesia

Propofol DRUG

2mg / kg

Endoscopy of Intravenous Anesthesia

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100000, China

Location

Related Publications (2)

• 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.

  PMID: 16810592 BACKGROUND

• 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.

  PMID: 37355565 DERIVED

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• peng Li, doctor

  Beijing Friendship Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Beijing Friendship Hospital Gastroenterology

Study Record Dates

• First Submitted: October 25, 2014
• First Posted: October 31, 2014
• Study Start: November 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: October 31, 2014

Record last verified: 2014-10

Locations

CN (1)