Actively Recruiting

Phase Not Applicable
All Genders
ID06318715

Comparison of Modified Deep Extubation versus Standard Awake Extubation to Reduce Operating Room Time in Laparoscopic Surgery

Led by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Updated on 2025-07-09

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two methods of removing breathing tubes after laparoscopic surgery under general anesthesia in low-risk patients. The study evaluates a modified deep extubation (mDE) technique, performed while patients are still anesthetized but with a lower dose of anesthetic gas and balanced with long-acting opioids, against the standard awake extubation (AE) method. The goal is to see if mDE can shorten the time from the end of surgery to when patients are ready to leave the operating room by at least 5 minutes. Participants will be randomly assigned to either the mDE group, where anesthesia is reduced to a low level and patients are extubated while still anesthetized under specific respiratory criteria, or the AE group, where patients are extubated once awake and able to follow commands. Both groups will receive reversal of muscle relaxation confirmed by nerve stimulation, oral suctioning, and airway support as needed. The study includes detailed monitoring of anesthesia doses, ventilation settings, and opioid use during the extubation process. During surgery and recovery, researchers will observe and record times related to surgery end, extubation, and discharge readiness from the post-anesthesia care unit (PACU). They will also assess airway maneuvers used, vital signs before and after extubation, and patient experiences in recovery. Participants will be interviewed once fully awake, and any complications will be managed per usual care. The study aims to provide detailed timing and safety data comparing these two extubation methods.

CONDITIONS

Brief Title

Modified Deep Extubation vs. Standard Awake Extubation

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ASA physical status I to III
  • Scheduled for laparoscopic surgery under general anesthesia
Not Eligible

You will not qualify if you...

  • Documented difficult airway during intubation or developed intraoperatively
  • Full stomach
  • Pregnant women
  • Emergency surgery
  • Body mass index (BMI) greater than 30
  • Intraoperative bleeding requiring transfusion
  • Use of remifentanil during extubation
  • Requirement for prone position during surgery
  • Absolute indication for awake or deep extubation
  • Use of opioids in chronic pain patients

AI-Screening

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Your Study Journey

Screening

Duration - Up to 1 day before surgery

Participants are screened for eligibility to participate in the trial.

1 visit (Pre-Admission Unit assessment)

Treatment

Duration - Day of surgery

Participants undergo laparoscopic surgery under general anesthesia and receive either modified deep extubation or standard awake extubation during recovery from anesthesia.

1 surgery and extubation procedure visit (in-person)

Post-operative Follow-up

Duration - Until discharge from PACU on the day of surgery

Participants are observed and interviewed in the post-anesthesia care unit (PACU) regarding their recovery experience after extubation.

1 post-operative visit (in-person)

Trial Site Locations

Total: 1 location

1

Department of Anesthesia Mount Sinai Hospital

Toronto, Ontario, Canada, M5G 1X5

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Research Team

N

naveed siddiqui, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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