Comparing modified deep extubation to standard awake extubation
A Comparison of a Modified Deep Extubation to Standard Awake Extubation for Decreasing Operating Room Time: a Randomized Controlled Trial
NA · Samuel Lunenfeld Research Institute, Mount Sinai Hospital · NCT06318715
This study is testing if a new way of waking patients up after laparoscopic surgery can help them leave the operating room faster than the usual method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Sex | All |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06318715 on ClinicalTrials.gov |
What this trial studies
This study compares two extubation techniques for low-risk patients undergoing laparoscopic surgery under general anesthesia: modified deep extubation (mDE) and standard awake extubation (AE). The mDE technique involves extubation while the patient is still anesthetized but with a lower dose of anesthetic gas, balanced with long-acting opioids to minimize airway reactions. The goal is to determine if mDE can reduce the time from the end of surgery to when the patient is ready to leave the operating room by at least 5 minutes compared to standard AE. Patients will be selected based on specific inclusion and exclusion criteria during their pre-admission assessment.
Who should consider this trial
Good fit: Ideal candidates are ASA I-III patients scheduled for elective laparoscopic surgery under general anesthesia.
Not a fit: Patients who are high-risk, such as those with a documented difficult airway or those requiring emergency surgery, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster recovery times for patients after laparoscopic surgery.
How similar studies have performed: Previous studies have indicated that modified deep extubation techniques can be as safe as standard awake extubation, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toronto, Ontario
- Department of Anesthesia Mount Sinai Hospital — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: naveed siddiqui, MD
- Email: naveed.siddiqui@uhn.ca
- Phone: 416-586-5270
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Extubation