Comparing recovery times of half dose sugammadex and neostigmine after surgery
Comparison of Recovery Times Between 1 mg/kg Sugammadex and 60 mcg/kg Neostigmine for Moderate Neuromuscular Blockade Induced by Rocuronium in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial
This study is testing whether a half dose of sugammadex works better than neostigmine to help people recover faster from anesthesia after gallbladder surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | Universitas Padjadjaran Academic / other |
| Locations | 1 site (Bandung, West Java) |
| Trial ID | NCT06794450 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of half dose sugammadex and neostigmine in reversing the effects of rocuronium, a neuromuscular blocking agent, used during laparoscopic cholecystectomy under general anesthesia. Participants will receive either sugammadex or neostigmine after surgery to evaluate which agent provides a faster and more predictable recovery time from neuromuscular blockade. The study aims to address the limitations of neostigmine's indirect action and the high cost of sugammadex by investigating a lower dose of the latter. The findings could lead to improved postoperative outcomes and reduced complications associated with residual neuromuscular blockade.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-59 who have undergone laparoscopic cholecystectomy with the use of rocuronium.
Not a fit: Patients with a history of drug allergies to the agents used, renal dysfunction, musculoskeletal disorders, central nervous system disorders, or difficult airways may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and cost-efficient method for reversing neuromuscular blockade, leading to quicker recovery times for patients.
How similar studies have performed: While the use of sugammadex has been studied, this specific comparison with half doses against neostigmine is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bandung, West Java
- Hasan Sadikin General Hospital — Bandung, West Java, Indonesia (Recruiting)
Study contacts
- Study coordinator: Rivan P Rivan Putra Afewa, M.D., M.D.
- Email: rivan.chaniago@gmail.com
- Phone: +6285316832464
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.