Recruiting

mDEA Comparison of a Modified Deep Extubation to Standard Awake Extubation for Decreasing Operating Room Time: a Randomized Controlled Trial

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

modified deep extubation (mDE)

+ standard awake extubation

Procedure
Who is being recruted

See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2024
See protocol details

Summary

Principal SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital
Study Contactnaveed siddiqui, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 8, 2024

Actual date on which the first participant was enrolled.

This clinical trial aims to compare two different methods of removing a breathing tube from patients after surgery, known as extubation. The study focuses on patients who are considered low-risk for airway complications and are scheduled for laparoscopic surgery under general anesthesia. The trial seeks to determine which method, the standard awake extubation or a modified deep extubation, is more efficient in terms of reducing time spent in the operating room while ensuring patient safety and comfort. The findings could help improve surgical recovery processes and optimize anesthesia practices for this specific group of patients. Participants in the study are randomly assigned to one of the two extubation methods. In the standard awake extubation group, patients are gradually brought out of anesthesia and extubated once they can follow simple verbal commands. In the modified deep extubation group, patients are extubated while still under light anesthesia, allowing for spontaneous breathing. Throughout the process, researchers closely monitor the patients and record various outcomes, such as the time taken for extubation and any complications. Participants provide feedback on their recovery experience once fully awake, contributing valuable insights into the effectiveness and safety of both techniques. The study ensures patient safety by excluding those with certain risk factors and by having anesthesiologists available to manage any unforeseen issues during extubation.

Official TitleA Comparison of a Modified Deep Extubation to Standard Awake Extubation for Decreasing Operating Room Time: a Randomized Controlled Trial
NCT06318715
Principal SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital
Study Contactnaveed siddiqui, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Department of Anesthesia Mount Sinai Hospital

Toronto, CanadaOpen Department of Anesthesia Mount Sinai Hospital in Google Maps
Recruiting
One Study Center
mDE | A Comparison of a Modified Deep Extubation to Standard Awake Extubation for Decreasing Operating Room Time: a Randomized Controlled Trial | PatLynk