Comparing two medications for reversing muscle relaxation in elderly patients during surgery
A Blinded Randomized Study of Neostigmine/Glyco-pyrrolate 50 Mikrogram/kg or Sugammadex 2 mg/kg for Reversal of Neuromuscular Blockade in Elderly Patients (≥ 75 Years)
This study is testing which of two medications works better to help older patients recover from muscle relaxation during robotic surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 3 sites (Copenhagen and 2 other locations) |
| Trial ID | NCT06228092 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of neostigmine/glycopyrrolate and sugammadex in reversing neuromuscular blockade in patients aged 75 and older undergoing robotic-assisted laparoscopic surgery. The study will measure the time taken to achieve a train-of-four (TOF) ratio of ≥ 0.9 after administration of either reversal agent. Given the increased risk of postoperative complications in elderly patients, this research seeks to identify the optimal reversal agent to enhance recovery and reduce adverse outcomes. Participants will be randomly assigned to receive one of the two treatments, and their recovery times will be closely monitored.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 75 years and older who are scheduled for robotic-assisted laparoscopic surgery requiring neuromuscular blockade.
Not a fit: Patients with known allergies to the study medications, severe renal impairment, or neuromuscular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery times and reduced postoperative complications for elderly patients undergoing surgery.
How similar studies have performed: Previous studies have indicated the need for optimal reversal agents in elderly patients, but this specific comparison of neostigmine/glycopyrrolate versus sugammadex is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients ≥ 75 years old 2. Informed consent 3. Scheduled for robotic assisted laparoscopic surgery under general anesthesia with intubation and use of rocuronium during the entire operation 4. American Society of Anesthesiologists (ASA) physical status classification I to IV 5. Can read and understand Danish Exclusion Criteria: 1. Known allergy to rocuronium, sugammadex or neostigmine/glycopyrrolate 2. Neuromuscular disease that may interfere with neuromuscular data 3. Severe renal impairment defined as eGFR \< 30 ml/min 4. Indication for rapid sequence induction 5. Known intestinal or ureter obstruction 6. Known peritonitis
Where this trial is running
Copenhagen and 2 other locations
- Department of anaesthesia, Centre of Head and Orthopedics, Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Bispebjerg Hospital — Copenhagen, Denmark (Recruiting)
- Department of Pediatric and Obstetric Anaesthesia, Rigshospitalet — Copenhagen, Denmark (Not_yet_recruiting)
Study contacts
- Study coordinator: Matias Vested, MD, PhD
- Email: matias.vested@regionh.dk
- Phone: +4535457547
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.