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Safety of Driving After Minor Surgery With Monitored Anesthesia Care

Study acronym: MACDrive
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Nov 2025 to Nov 2026
    • Study completion date: Dec 2025 to Dec 2026
    v24
  2. Primary completion date: Nov 2024 to Nov 2025
    • Study completion date: Dec 2024 to Dec 2025
    v23
  3. Primary completion date: Nov 2023 to Nov 2024
    • Study completion date: Dec 2023 to Dec 2024
    v22
  4. Primary completion date: Nov 2022 to Nov 2023
    • Study completion date: Dec 2022 to Dec 2023
    v21
  5. Primary completion date: Jul 2021 to Nov 2022
    • Study completion date: Dec 2021 to Dec 2022
    v20
Show 18 earlier versionsHide 18 earlier versions
  1. Primary completion date: Jul 2020 to Jul 2021
    • Study completion date: Jul 2020 to Dec 2021
    v19
  2. Re-verified, no change to tracked fieldsv18
  3. Primary and study completion dates: Jul 2018 to Jul 2020v17
  4. Primary and study completion dates: Dec 2017 to Jul 2018v16
  5. Primary and study completion dates: Dec 2015 to Dec 2017v15
  6. Primary completion date: Dec 2014 to Dec 2015
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Mar 2015 to Dec 2015
    • Site details revised
    v14
  7. Primary completion date: Oct 2014 to Dec 2014
    • Study completion date: Nov 2014 to Mar 2015
    v13
  8. Primary completion date: Oct 2013 to Oct 2014
    • Study completion date: Nov 2013 to Nov 2014
    v12
  9. Primary completion date: Jan 2013 to Oct 2013
    • Study completion date: Feb 2013 to Nov 2013
    • Study description shortened, about 15 words
    • Study arms: 5 to 3
    v11
  10. Primary completion date: Nov 2012 to Jan 2013
    • Study completion date: Dec 2012 to Feb 2013
    • Interventions: Control (Other), Midazolam (Drug), Propofol (Drug), Sufentanil (Drug) to Midazolam (Drug), Propofol (Drug), Sufentanil (Drug)
    v10
  11. Primary completion date: Nov 2011 to Nov 2012
    • Study completion date: Dec 2011 to Dec 2012
    • Eligibility criteria expanded, about 3 words
    v9
  12. Interventions: Midazolam (Drug), Propofol (Drug), Sufentanil (Drug) to Control (Other), Midazolam (Drug), Propofol (Drug), Sufentanil (Drug)
    • Eligibility criteria expanded, about 24 words
    • Study description expanded, about 65 words
    v8
  13. Re-verified, no change to tracked fieldsv7
  14. Primary completion date: Nov 2010 to Nov 2011
    • Study completion date: Dec 2010 to Dec 2011
    v6
  15. Primary completion date: Nov 2009 to Nov 2010v5 Show 4 more changesShow less
    • Enrollment target: 500 to 625
    • Study completion date: Dec 2009 to Dec 2010
    • Interventions: Midazolam + Propofol (Drug), Midazolam + Sufentanil + Propofol (Drug), Propofol (Drug), Sufentanil + Propofol (Drug) to Midazolam (Drug), Propofol (Drug), Sufentanil (Drug)
    • Study arms: 4 to 5
  16. Primary completion date: Jul 2009 to Nov 2009v4
  17. Re-verified, no change to tracked fieldsv3
  18. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jul 2009
    • Study completion date: Jul 2009 to Dec 2009
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00577200
Lead Sponsor Rush University Medical Center
Conditions
(from sponsor)		 Minor Surgical Procedures With Monitored Anesthesia Care, Driving Performance After Minor Ambulatory Surgery
Enrollment 625 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov