Phase 3
N=198
Comparison of Sugammadex (Org 25969) With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (P05960)
Anesthesia, General
Bottom Line
View on ClinicalTrials.gov: NCT00451217 ↗Enrolled (actual)
198
Serious AEs
2.7%
Results posted
Feb 2019
Primary outcome: Primary: Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9. — 1.62; 26.78; 4.47; 23.43 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sugammadex (Drug); Neostigmine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Mar 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9. |
1.62; 26.78; 4.47; 23.43 | — |
| SECONDARY Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 |
1.17; 9.60; 1.68; 9.52 | — |
| SECONDARY Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 |
1.32; 15.32; 2.12; 15.33 | — |
| SECONDARY Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation |
30; 35; 29; 26; 16; 13 | — |
| SECONDARY Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room |
46; 48; 48; 43; 1; 0 | — |
Summary
The purpose of this study was to demonstrate in adult participants faster recovery from a neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch, T1) by 2.0 mg/kg sugammadex (Org 25969) compared to 50 ug/kg neostigmine.
Eligibility Criteria
Inclusion Criteria
- Is of American Society of Anesthesiologists (ASA) 1 - 4;
- Is above or equal to the age of 18;
- Scheduled for surgical procedures with a general anesthesia with the use of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block;
- Scheduled for surgical procedure in supine position;
- Given written informed consent.
Exclusion Criteria
- Participants in whom a difficult intubation because of anatomical malformations was expected;
- Is known or suspected to have neuromuscular disorders impairing neuromuscular block (NMB) and/or significant renal dysfunction;
- Is known or suspected to have a (family) history of malignant hyperthermia;
- Is known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
- Is receiving medication in a dose and/or at a time point known to interfere with neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+;
- Participants in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
- Had already participated in a sugammadex trial;
- Had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into P05960.
- Females who are pregnant:
- Females of childbearing potential not using any method of birth control: condom or using only hormonal contraception as birth control;
- Females who were breast-feeding.
Data sourced from ClinicalTrials.gov (NCT00451217). 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.