Recruiting

mDE vs. AE

Sponsor:

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Code:

NCT06318715

Conditions

Extubation

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

modified deep extubation (mDE)

standard awake extubation

Study Details

Brief summary:

The proposed study is to compare a modified DE technique, which is regularly used for low-risk patients by staff anesthesiologists at our institution, to a standard awake extubation. This modified deep extubation (mDE) occurs while the patient is still anaesthetized but at a lower dose of anaesthetic gas than previously described, and balanced with long acting opioids to attenuate the airway reaction. As previously stated, the literature shows that the risks of DE are equivalent to those of regular AE practice. Our hypothesis is that mDE will shorten the time from the end of the surgery (completion of last stitch) to the moment the patient is ready to leave the OR by at least 5 minutes when compared to standard AE practice.

Conditions

Extubation

Study ID

NCT06318715

Start date

Apr 8, 2024

Status verified date

Jul, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ASA I-III
  • laparoscopic surgery under general anesthesia

Exclusion Criteria:

  • High-risk patients:

  • Documented difficult airway during intubation or developed intraoperatively.
  • Full stomach
  • Pregnant women
  • Emergency surgery
  • BMI>30
  • Intraoperative bleeding leading to transfusion
  • Use of remifentanil during extubation
  • Requirement for prone position for surgical approach (i.e., spine surgery, anal fistulectomy, tumor resection of the back, etc)
  • Absolute indication for awake or deep extubation
  • Use of opioids in chronic pain patients

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: modified deep extubation

This modified deep extubation (mDE) occurs while the patient is still anaesthetized but at a lower dose of anaesthetic gas than previously described, and balanced with long acting opioids to attenuate the airway reaction.

experimental: standard awake extubation

awake extubation (AE) is still considered the standard practice.

Interventions

modified deep extubation (mDE)

The proposed study is to compare a modified DE technique, which is regularly used for low-risk patients by staff anesthesiologists at our institution, to a standard awake extubation.

standard awake extubation

awake extubation (AE) is still considered the standard practice.

Primary outcome measure

  • Time from the end of the surgery to leaving the OR [ Time Frame: Time from the end of the surgery (completion of the last stitch) to the time the patient is ready to safely leave the OR ]

Central Contacts and Locations

Central contacts

naveed siddiqui, MD

416-586-5270naveed.siddiqui@uhn.ca

Locations

Department of Anesthesia Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Naveed Siddiqui, MD

416-586-4800naveed.siddiqui@uhn.on.ca

Principal Investigator:

Naveed Siddiqui, MD

More Information

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Last update posted

Jul 9, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Samuel Lunenfeld Research Institute, Mount Sinai Hospital on 2025-07-09.