Modified Deep Extubation vs. Standard Awake Extubation

NCT06318715 | Recruiting

• 1 other identifier: 23-0009-A
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time from the end of the surgery to leaving the OR

  Time from the end of the surgery (completion of the last stitch) to the time the patient is ready to safely leave the OR (defined as the moment when the patient breaths spontaneously with SpO2 \> 97 % while receiving oxygen by a facial mask at 6-8 L/min, with normal chest wall movement, no airway obstruction and the presence of ETCO2 waveform).

  Time from the end of the surgery (completion of the last stitch) to the time the patient is ready to safely leave the OR

Secondary Outcomes (19)

• Time from the end of the surgery to extubation

  Time from the end of the surgery (completion of the last stitch) to the moment of extubation

• Time from the end of the surgery to discharge from PACU

  Time from the end of the surgery to the moment the patient is ready to be discharged from PACU

• oral airway

  from intubation to extubation during the surgery/procedure

• jaw-thrust maneuver

  from intubation to extubation during the surgery/procedure

• hypertension

  During the first 5 minutes after extubation

Study Arms (2)

modified deep extubation

EXPERIMENTAL

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.

Procedure: modified deep extubation (mDE)

standard awake extubation

EXPERIMENTAL

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

Procedure: standard awake extubation

Interventions

modified deep extubation (mDE) PROCEDURE

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.

modified deep extubation

standard awake extubation PROCEDURE

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

standard awake extubation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-III
• laparoscopic surgery under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Department of Anesthesia Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

Central Study Contacts

naveed siddiqui, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: March 19, 2024
• Study Start: April 8, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

CA (1)