60 Participants Needed

Modified Deep vs. Standard Awake Extubation

(mDE Trial)

ns
Overseen Bynaveed siddiqui, MD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The available research does not provide any data on Modified Deep vs. Standard Awake Extubation. The studies focus on treatments for multiple myeloma, rheumatoid arthritis, and COPD, but none of them mention or evaluate the effectiveness of Modified Deep vs. Standard Awake Extubation.12345

What safety data exists for Modified Deep vs. Standard Awake Extubation?

The provided research does not contain specific safety data for Modified Deep vs. Standard Awake Extubation or any of its variations. The studies focus on adverse drug events and generic product substitutions, not on extubation techniques.678910

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

ASA I-III
I am having surgery with small incisions under general anesthesia.

Exclusion Criteria

Pregnant women
Patients with full stomach
Patients using opioids in chronic pain management
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Preoperative Assessment

Patients undergo assessment in the Pre-Admission Unit (PAU) and are introduced to the study

1 day
1 visit (in-person or phone)

Randomization and Extubation Procedure

Patients are randomized to either the AE or mDE group and undergo the extubation procedure

Day of surgery
1 visit (in-person)

Post-Anesthesia Care Unit (PACU) Monitoring

Patients are monitored in the PACU for recovery and interviewed about their experience

Until discharge from PACU
1 visit (in-person)

Follow-up

Participants are monitored for any complications or adverse events post-extubation

1 day

Treatment Details

Interventions

  • Modified Deep Extubation
  • Standard Awake Extubation
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Lead Sponsor

Trials
132
Recruited
11,400+

Findings from Research

The phase 3 FIRST trial demonstrated that continuous treatment with lenalidomide plus low-dose dexamethasone (Rd continuous) significantly prolonged progression-free survival and overall survival in transplant-ineligible patients with newly diagnosed multiple myeloma compared to standard treatment with melphalan, prednisone, and thalidomide (MPT).
In patients achieving complete response (CR) or very good partial response (VGPR), Rd continuous reduced the risk of progression or death by up to 67% compared to MPT, and showed similar survival rates to Rd for 18 cycles, indicating its effectiveness across various levels of treatment response.
Benefit of continuous treatment for responders with newly diagnosed multiple myeloma in the randomized FIRST trial.Bahlis, NJ., Corso, A., Mugge, LO., et al.[2018]
In a study of 1107 rheumatoid arthritis patients, DMARD (disease-modifying antirheumatic drug) intensification was primarily influenced by patient-reported outcomes (PROs), accounting for 61% of the decisions, compared to 42% from doctor-reported outcomes (DROs).
Despite having high disease activity (DAS28 >3.2), only 15% of patients received DMARD intensification, highlighting a gap in treatment adjustments based on inflammation levels versus patient symptoms.
Relative importance of doctor-reported outcomes vs patient-reported outcomes in DMARD intensification for rheumatoid arthritis: the DUO study.Dougados, M., Nataf, H., Steinberg, G., et al.[2015]
In a study of 140 patients with relapsed or refractory multiple myeloma, those treated with low-dose dexamethasone (Rd) alongside lenalidomide showed a median overall survival of 41 months, compared to 20 months for those on intermediate doses (RD).
While both treatment regimens resulted in similar partial response rates (62% for RD and 73% for Rd), the low-dose regimen (Rd) was associated with fewer severe side effects, such as grade 3 and 4 neutropenia and fatigue, indicating it may be a safer option without compromising efficacy.
Lenalidomide with low- or intermediate-dose dexamethasone in patients with relapsed or refractory myeloma.Zagouri, F., Roussou, M., Kastritis, E., et al.[2019]

References

Benefit of continuous treatment for responders with newly diagnosed multiple myeloma in the randomized FIRST trial. [2018]
Relative importance of doctor-reported outcomes vs patient-reported outcomes in DMARD intensification for rheumatoid arthritis: the DUO study. [2015]
Lenalidomide with low- or intermediate-dose dexamethasone in patients with relapsed or refractory myeloma. [2019]
Bortezomib, Lenalidomide and Dexamethasone (VRd) vs Carfilzomib, Lenalidomide and Dexamethasone (KRd) as Induction Therapy in Newly Diagnosed Multiple Myeloma. [2023]
When to Use Initial Triple Therapy in COPD: Adding a LAMA to ICS/LABA by Clinically Important Deterioration Assessment. [2021]
[Adverse events related to substitution of generic products in Norway 2005]. [2013]
[Adverse drug events in patients hospitalized in internal medicine]. [2013]
Patient-relevant outcomes associated with generic tamsulosin, levothyroxine and amphetamine in the FDA Adverse Event Reporting System: a pilot study. [2022]
Life-Threatening and Fatal Adverse Drug Events in a Danish University Hospital. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Serious Adverse Drug Events Reported to the FDA: Analysis of the FDA Adverse Event Reporting System 2006-2014 Database. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Efficacy of mechanical insufflation-exsufflation in extubating unweanable subjects with restrictive pulmonary disorders. [2022]
Continuous noninvasive ventilatory support outcomes for patients with neuromuscular disease: a multicenter data collaboration. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
Evaluation of two different extubation criteria: attributes contributing to success. [2019]
14.United Statespubmed.ncbi.nlm.nih.gov
Cardiopulmonary effects of intermittent mandatory ventilation. [2019]
Effects of mechanical insufflation-exsufflation in preventing respiratory failure after extubation: a randomized controlled trial. [2022]
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