Safety of Driving After Minor Surgery With Monitored Anesthesia Care

NCT00577200 | Active Not Recruiting Phase 4

• 1 other identifier: ABuv110507
• Study Type: interventional
• Target: 625
• Locations: 1 country
• Sites: 1

Brief Summary

Patients are currently advised to refrain from driving motor vehicles or using public transportation unescorted for a 24 hour period if they undergo any minor ambulatory surgical procedure with monitored anesthesia care (MAC).However, recently introduced short-acting anesthetics may facilitate rapid recovery and an early return to normal daily activities. The proposed study will compare newer short-acting anesthetic agents (propofol, benzodiazepine, opioid) utilized in MAC, to determine if a particular pharmacological agent, or a combination of agents, impair driving performance as evaluated by driving simulator assessment, at time of discharge from the ambulatory center after minor surgical procedures.Subjects will be grouped as patients with chronic pain undergoing procedures and those without chronic pain undergoing procedures. Subjects with pain issues will be randomized with either 1)Midazolam + Sufentanil + Propofol or 2)Midazolam + Sufentanil. There will be a third group of subjects who are controls not undergoing any procedures.

Conditions

Minor Surgical Procedures With Monitored Anesthesia Care; Driving Performance After Minor Ambulatory Surgery

Outcome Measures

Primary Outcomes (1)

• Weaving, measured as the standard deviation of lateral position.

  6 h

Secondary Outcomes (1)

• Reaction time (RT)

  6 h

Study Arms (3)

Control

NO INTERVENTION

Control group subjects are not undergoing any surgical procedures and will not be randomized to any anesthetic drug group.

Midazolam + Sufentanil + Propofol

EXPERIMENTAL

Midazolam 0.03 mg/kg + Sufentanil 0.1 µg/kg + Propofol bolus of 300 µg/kg + infusion at 75 µg/kg/min. "For subjects who are chronic pain patients undergoing minor surgical procedures."

Drug: Midazolam; Drug: Sufentanil; Drug: Propofol

Midazolam and Sufenatnil

EXPERIMENTAL

Midazolam 1-5 mg in holding area + Sufentanil 5-10 mcg. "For subjects who are chronic pain patients undergoing minor surgical procedures."

Drug: Midazolam; Drug: Sufentanil

Interventions

Midazolam DRUG

Midazolam

Also known as: Dormicum, Hypnovel, Midacum, Versed

Midazolam + Sufentanil + Propofol; Midazolam and Sufenatnil

Sufentanil DRUG

Sufentanil

Also known as: Sufenta

Midazolam + Sufentanil + Propofol; Midazolam and Sufenatnil

Propofol DRUG

Propofol bolus of 300 µg/kg + infusion at 75 µg/kg/min.

Also known as: Diprivan

Midazolam + Sufentanil + Propofol

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulatory surgical patient possessing a valid driving license and presenting for a minor procedure that does not physically impact ability to drive (such as hand, arm, and lower extremity surgery).
• Another group of subjects who are not scheduled for a procedure will be given a driving simulator exercise and they will be control group.

You may not qualify if:

• Any surgical case that lasted more than one hour and required general anesthesia will be excluded.
• Patients with a history of chronic benzodiazepine or alcohol abuse, alcohol or other substance dependence or recent use of medications with sleep altering qualities, and driving simulator sickness.
• Patients who cannot follow a simple driving task and cannot sit on a chair for the driving test due to medical conditions will also be excluded.
• History of seizures

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

Midazolam; Sufentanil; Propofol

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Asokumar Buvanendran, M.D.

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 20, 2007
• Study Start: January 1, 2008
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (1)