Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- ASA physical status I to III
- Scheduled for laparoscopic surgery under general anesthesia
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 1 day before surgery
Participants are screened for eligibility to participate in the trial.
1 visit (Pre-Admission Unit assessment)
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)
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
Actively Recruiting
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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