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Sugammadex vs Neostigmine for Anesthesia Recovery in Obstructive Sleep Apnea

Phase 4
Waitlist Available
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline paco2 arterial blood gas measurements will be measured 10 minutes prior to entry to the operating room; post-operative paco2 arterial blood gas measurements will be measured 30 minutes after pacu admission
Awards & highlights

Study Summary

This trial looks at whether sugammadex or neostigmine is more effective in helping obese patients with obstructive sleep apnea recover from anesthesia and improve their lung function.

Who is the study for?
This trial is for obese individuals (BMI >30) with obstructive sleep apnea who are scheduled for outpatient surgery requiring general anesthesia. Candidates should not have a history of difficult airway management, adverse reactions to specific muscle relaxants or reversal agents, or significant liver, kidney, heart, or brain blood vessel problems.Check my eligibility
What is being tested?
The study compares Sugammadex and Neostigmine in speeding up recovery from muscle relaxation used during surgery and improving lung function post-operation in bariatric patients with sleep apnea undergoing outpatient procedures.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs being tested. Since both medications are used to reverse anesthesia effects after surgery, they may also cause changes in heart rate or blood pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline peak expiratory flow (pef) will be measured 10 minutes prior to entry to the operating room; post-operative pef will be measured 30 minutes after pacu admission
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline peak expiratory flow (pef) will be measured 10 minutes prior to entry to the operating room; post-operative pef will be measured 30 minutes after pacu admission 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 to PACU Discharge
Secondary outcome measures
Compare Proportional Changes Between Baseline Forced Vital Capacity (FVC) and Postoperative FVC Between Subjects Receiving Sugammadex and Those Receiving Neostigmine.
Compare Proportional Changes Between Baseline PaCO2 Measured Via Arterial Blood Gas and Postoperative PaCO2 (Measured Via Arterial Blood Gas) Between Subjects Receiving Sugammadex and Those Receiving Neostigmine.
Compare Proportional Changes Between Baseline PaO2 Measured Via Arterial Blood Gas and Postoperative PaO2 (Measured Via Arterial Blood Gas) Between Subjects Receiving Sugammadex and Those Receiving Neostigmine.
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: SugammadexActive Control1 Intervention
Group II: NeostigminePlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,317 Total Patients Enrolled

Media Library

Sugammadex Clinical Trial Eligibility Overview. Trial Name: NCT04570150 — Phase 4
Anesthesia Research Study Groups: Sugammadex, Neostigmine
Anesthesia Clinical Trial 2023: Sugammadex Highlights & Side Effects. Trial Name: NCT04570150 — Phase 4
Sugammadex 2023 Treatment Timeline for Medical Study. Trial Name: NCT04570150 — Phase 4

Frequently Asked Questions

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

Is geriatric participation accepted in this research endeavor?

"The age range for participations in this experiment is between 18 and 80 years old."

Answered by AI

What is the aim of this medical experiment?

"The primary outcome to be monitored in this trial will concern the amount of time it takes for patients to leave the PACU following surgery, measured against a train-of-four ratio >0.9. Secondary outcomes include analysis of pre/postoperative FVC and PaCO2 levels as well as PEF levels after neuromuscular block reversal with sugammadex or neostigmine."

Answered by AI

What criteria must one meet in order to qualify for this clinical trial?

"Admittance to this trial is contingent upon a patient's age (18-80) and their previous experience with anaesthesia. Currently, the study seeks 120 participants."

Answered by AI

Are there still opportunities for patients to participate in this experiment?

"It is verifiable on clinicaltrials.gov that this study is currently enrolling patients. It was first advertised the 4th of January 2021, with its latest update occurring 3rd May 2022."

Answered by AI

What applications is Sugammadex typically utilized for?

"Sugammadex is widely used to address neuromuscular blockade, but it may also prove beneficial for post-operative intestinal atony, denture retention and myasthenia gravis."

Answered by AI

How many participants has the research team recruited for this investigation?

"Affirmative, the details on clinicaltrials.gov specify that this research is presently recruiting volunteers. This trial began recruitment in April 2021 and was most recently updated May 2022; it requires 120 participants at a single site."

Answered by AI

Has Sugammadex been approved by the Food and Drug Administration?

"Backed by successful Phase 4 trials, sugammadex is rated a 3 for safety."

Answered by AI

Is there prior evidence for the efficacy of Sugammadex?

"Currently, there are 15 ongoing trials with one in Phase 3 for Sugammadex. Primarily located in Rochester, Minnesota, 51 sites across the country are hosting clinical studies using this medication."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Optimizing Post-operative Recovery in Bariatric Patients With Obstructive Sleep Apnea Undergoing Outpatient Surgery: A Comparison of Sugammadex and Neostigmine
Jerry Ingrande 2021. "Optimizing Post-operative Recovery in Bariatric Patients With Obstructive Sleep Apnea Undergoing Outpatient Surgery: A Comparison of Sugammadex and Neostigmine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04570150.
~21 spots leftby Apr 2025
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