mDEA Comparison of a Modified Deep Extubation to Standard Awake Extubation for Decreasing Operating Room Time: a Randomized Controlled Trial
modified deep extubation (mDE)
+ standard awake extubation
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy 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
Department of Anesthesia Mount Sinai Hospital
Toronto, CanadaOpen Department of Anesthesia Mount Sinai Hospital in Google Maps