CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,198 enrolled
Drug / intervention
Sugammadex +3 moredrug
Likely dose
Sugammadex 4 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01422304
NCT01422304Phase 3Completed
CompareCT.gov

A Randomized, Controlled, Parallel-group, Double-blind Trial of Sugammadex or Usual Care (Neostigmine or Spontaneous Recovery) for Reversal of Rocuronium- or Vecuronium-induced Neuromuscular Blockade in Patients Receiving Thromboprophylaxis and Undergoing Hip Fracture Surgery or Joint (Hip/Knee) Replacement (Protocol No. P07038)

Merck Sharp & Dohme LLC·interventional·Posted Aug 23, 2011·Updated Feb 12, 2021

In Brief

A Phase 3 clinical trial evaluating Sugammadex, neostigmine and glycopyrrolate or atropine, and 2 other interventions for Neuromuscular Blockade and 4 related conditions. Completed, enrolled 1,198 participants.

Detailed Summary

This study will assess the effect of reversal of neuromuscular blockade with sugammadex compared with reversal according to usual care (neostigmine or spontaneous reversal) on the incidence of post-surgical bleeding events and on coagulation parameters in participants undergoing hip fracture surgery or joint (hip/knee) replacement surgery with neuromuscular blockage induced by rocuronium or vecuronium.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuromuscular Blockade, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Blood Coagulation, Antithrombotic Agents
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 23, 2011
Enrollment StartOct 12, 2011
Primary CompletionSep 26, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.9 years ago

Interventions

Sugammadexdrug

Sugammadex 4 mg/kg intravenously

neostigmine and glycopyrrolate or atropinedrug

Neostigmine and glycopyrrolate or neostigmine and atropine administered intravenously per usual practice and per the product labels

Placebo to neostigminedrug

Normal saline (NaCl 0.9%)

Placebo to sugammadexdrug

Normal saline (NaCl 0.9%)