Recovery Times of Half Dose Sugammadex and Neostigmine for Rocuronium-induced Neuromuscular Blockade (NCT06794450) | Clinical Trial Compass
RecruitingPhase 1/2
Recovery Times of Half Dose Sugammadex and Neostigmine for Rocuronium-induced Neuromuscular Blockade
Indonesia60 participantsStarted 2024-11-05
Plain-language summary
In operating procedure with general anesthesia muscle relaxant is usually used to increase success rate of the operation and to give better outcome. The use of reversal drugs aims to reduce the risk of post-operative complications due to muscle relaxants. Neostigmine is commonly used as a reversal drug, but its indirect mechanism of action results in a long and unpredictable recovery time. Sugammadex directly bind and inactivate rocuronium, in which resulting in a faster and predictable recovery time. However, the high price limits the use of sugammadex.
This study aims to compare the effect of half dose sugammadex and neostigmine against the moderate neuromuscular blockade of rocuronium.
The main questions it aims to answer are:
Does half dose sugammadex gives faster recovery time? Researchers will compare sugammadex to neostigmine to see if sugammadex gives faster recovery time.
Participants will:
Be given sugammadex or neostigmine as a reversal drug after the operation done
Who can participate
Age range
18 Years – 59 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:
* Patients who underwent laparoscopic cholecystectomy under general anesthesia
* Using muscle relaxant rocuronium
* Aged 18-59 years
* American Society of Anesthesiologists (ASA) physical status classification of 1 or 2.
Exclusion Criteria:
* History of drug allergies to the agents used
* Renal dysfunction
* Musculoskeletal disorders
* Central nervous system disorders
* Difficult airways requiring intubation without the use of muscle relaxants.
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.