Phase 3
N=140
Comparing 4.0 mg.Kg-1 Sugammadex With Placebo in the Reversal of Profound Neuromuscular Blockade (P05767)
Anesthesia · Neuromuscular Blockade
Bottom Line
View on ClinicalTrials.gov: NCT00758485 ↗Enrolled (actual)
140
Serious AEs
5.8%
Results posted
Apr 2013
Primary outcome: Primary: Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Placebo) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 — 2.2; 89.8 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sugammadex (Drug); 0.9% sodium chloride (NaCl) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Placebo) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 |
2.2; 89.8 | — |
| SECONDARY Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7 |
1.6; 70.1 | — |
| SECONDARY Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8 |
1.8; 78.8 | — |
Summary
The current trial was designed to demonstrate faster recovery in participants undergoing elective surgeries requiring profound neuromuscular blockade induced by rocuronium to a fourth twitch/first twitch (T4/T1) ratio of 0.9, after reversal of a target depth of neuromuscular blockade (NMB) of 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1 Sugammadex compared to Placebo, to evaluate the safety of 4.0 mg.kg-1 Sugammadex and to evaluate the Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay for these participants.
Eligibility Criteria
Inclusion Criteria
- Male or female participants
- American Society of Anesthesiologists (ASA) class 1, 2 or 3
- Age >=18 years
- Scheduled to undergo a surgery requiring profound NMB such as cardiovascular, gynaecologic, neurologic and thoracic surgical procedures under general anesthesia requiring neuromuscular relaxation with rocuronium for endotracheal intubation and if applicable maintenance of NMB in a position allowing neuromuscular monitoring
- Given written informed consent
Exclusion Criteria
- Participants known or suspected to have neuromuscular disorders affecting NMB
Data sourced from ClinicalTrials.gov (NCT00758485). 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.