CompletedPhase 4

Quality of Recovery After Reversal With Neostigmine or Sugammadex.

United States80 participantsStarted 2016-11

Plain-language summary

This study will compare patient recovery measures after reversal of neuromuscular blockade with neostigmine or sugammadex after surgery. Measures include pulmonary function, muscle strength, time to extubation and quality of recovery in the post anesthesia care unit.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participant must be willing and able to provide written informed consent for the study * Participant must be greater than or equal to 18 years of age * Participant must be ASA (American Society of Anesthesiologists) class I, II or III * Planned use of neuromuscular blocking drugs * Planned use of endotracheal intubation * Planned for extubation to occur in the OR Exclusion Criteria: * ASA (American Society of Anesthesiologists) Class IV * Age \< 18 years old * Inability to give oral or written consent * Known or suspected neuromuscular disorder impairing neuromuscular function * True allergy to muscle relaxants * A (family) history of malignant hyperthermia * A contraindication for neostigmine or sugammadex administration * Serum creatinine level of greater than 2.0 mg/dL * Surgery where the patient's arm is not available for neuromuscular monitoring * A plan to extubate under deep anesthesia * Pregnant

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incentive Spirometry, Change From Baseline and Recovery Profile - 30 Minutes

Timeframe: 30 Minutes

Incentive Spirometry, Change From Baseline and Recovery Profile - 60 Minutes

Timeframe: 60 Minutes after reversal

Incentive Spirometry, Change From Baseline and Recovery Profile - 120 Minutes

Timeframe: 120 minutes after reversal

Trial details

NCT IDNCT02909439

SponsorStony Brook University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-11-09

Results submitted2020-04-27

View on ClinicalTrials.gov More Incomplete Reversal of Neuromuscular Block trials