Modified Deep vs. Standard Awake Extubation
(mDE Trial)
Trial Summary
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you use opioids for chronic pain, you cannot participate in the trial.
What data supports the idea that Modified Deep vs. Standard Awake Extubation is an effective treatment?
What safety data exists for Modified Deep vs. Standard Awake Extubation?
Is Modified Deep Extubation a promising treatment?
Yes, Modified Deep Extubation is promising because it can help patients breathe better after being on a ventilator. It uses techniques like mechanical insufflation-exsufflation and noninvasive ventilation to improve breathing and reduce the need for re-intubation, which means patients can recover faster and spend less time in the ICU.1112131415
Eligibility Criteria
This trial is for patients with physical status classifications ASA I-III who are undergoing laparoscopic surgery under general anesthesia. It's not specified who can't join, but typically those with higher risks or conditions that could interfere with the study might be excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Assessment
Patients undergo assessment in the Pre-Admission Unit (PAU) and are introduced to the study
Randomization and Extubation Procedure
Patients are randomized to either the AE or mDE group and undergo the extubation procedure
Post-Anesthesia Care Unit (PACU) Monitoring
Patients are monitored in the PACU for recovery and interviewed about their experience
Follow-up
Participants are monitored for any complications or adverse events post-extubation
Treatment Details
Interventions
- Modified Deep Extubation
- Standard Awake Extubation
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Who Is Running the Clinical Trial?
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Lead Sponsor