Phase 3
Completed N=140
Comparison of Sugammadex With Neostigmine During Laparoscopic Cholecystectomy or Appendectomy (P05699)
Anesthesia, General
Source: ClinicalTrials.gov NCT00724932 ↗
Enrolled (actual)
140
Serious AEs
8.3%
Results posted
Apr 2013
Primary outcomePrimary: Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Neostigmine) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 — 2.4; 8.4 minutes — p=<0.0001
Summary
The current trial was designed to demonstrate faster recovery from a neuromuscular blockade (NMB) induced by rocuronium after reversal at 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1 sugammadex compared to 50 µg.kg-1 neostigmine at reappearance of second twitch (T2) in participants undergoing laparoscopic cholecystectomy or appendectomy under propofol anesthesia, to compare safety and to evaluate operating room and Post Anesthetic Care Unit (PACU) length of stay.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Neostigmine) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 |
2.4; 8.4 | <0.0001 sig |
| SECONDARY Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7 |
1.6; 4.1 | <0.0001 sig |
| SECONDARY Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8 |
1.9; 5.6 | <0.0001 sig |
| SECONDARY Number of Participants Who Experienced Pre-treatment Serious Adverse Events (SAEs) and Post-treatment SAEs |
1; 0; 4; 6 | — |
| SECONDARY Number of Participants Who Experienced Pre-treatment Non-serious Adverse Events (AEs) and Post-treatment Non-serious AEs |
38; 34; 65; 65 | — |
Eligibility Criteria
Inclusion Criteria
- Participants of American Society of Anesthesiologists class 1-3
- Participants of age above or equal to the age of 18 years
- Participants who are scheduled to undergo a laparoscopic cholecystectomy or appendectomy under general anesthesia requiring neuromuscular relaxation with rocuronium, and if applicable, maintenance of neuromuscular blockade
- Participants who have given written informed consent
Exclusion Criteria
- Participants in whom a difficult intubation because of anatomical malformations is expected
- Participants known or suspected to have neuromuscular disorders affecting NMB
- Participants known or suspected to have a significant renal dysfunction
- Participants known or suspected to have a severe hepatic dysfunction
- Participants known or suspected to have (family) history of malignant hyperthermia
- Participants known or suspected to have an allergy to opioids, muscle relaxants or other medication used during general anesthesia
- Participants in whom the use of neostigmine and/or atropine is contraindicated
- Female participants who are pregnant (pregnancy will be excluded for women both from medical history and by a human chorionic gonadotropin (hCG) test within 24h before surgery, except for women who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or a hysterectomy)
- Female participants who are breast-feeding
- Participants who participated in another clinical trial not pre-approved by the sponsor, within 30 days of entering into trial 19.4.318 (P05699)
- Participants who have already participated in a sugammadex trial
Data sourced from ClinicalTrials.gov (NCT00724932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.