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Procedure

standard awake extubation for Extubation (mDE Trial)

N/A

Recruiting

Research Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing laparoscopic surgery under general anesthesia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up just before extubation, and 1 minute and 5 minutes after extubation.

Awards & highlights

mDE Trial Summary

This trial aims to compare a modified deep extubation technique to the standard awake extubation method. The modified technique involves removing the breathing tube while the patient is still under anesthesia but with lower levels

Who is the study for?

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.Check my eligibility

What is being tested?

The study compares two ways of removing a breathing tube after surgery: standard awake extubation (AE) and modified deep extubation (mDE). mDE involves reducing anesthetic gas and using long-acting opioids to lessen airway reactions. The goal is to see if mDE speeds up recovery time in the operating room by at least 5 minutes.See study design

What are the potential side effects?

While specific side effects aren't listed, both AE and mDE may cause coughing or changes in blood pressure during waking from anesthesia. There's also a risk of airway complications which these methods aim to minimize.

mDE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having surgery with small incisions under general anesthesia.

mDE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from the end of the surgery to the moment the patient is ready to be discharged from pacu

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from the end of the surgery to the moment the patient is ready to be discharged from pacu

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from the end of the surgery to the moment the patient is ready to be discharged from pacu for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time from the end of the surgery to leaving the

Secondary outcome measures

EtCO2

+16 more

mDE Trial Design

2Treatment groups

Experimental Treatment

Group I: standard awake extubationExperimental Treatment1 Intervention

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

Group II: modified deep extubationExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor

127 Previous Clinical Trials

11,183 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants being selected for enrollment in this clinical trial?

"Indeed, information available on clinicaltrials.gov confirms the ongoing recruitment of subjects for this investigation. The study was first listed on April 3rd, 2024, and last modified on April 16th, 2024. Enrollment targets include recruiting a total of 60 participants across one designated site."

Answered by AI

Are there any available positions for participants in this research study?

"As per clinicaltrials.gov, this clinical investigation is actively seeking eligible participants. It was first listed on 4/3/2024 and most recently revised on 4/16/2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Modified Deep Extubation vs. Standard Awake Extubation

2024. "Modified Deep Extubation vs. Standard Awake Extubation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06318715.