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Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)

NCT01422304 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1198

Last updated 2021-02-12

Study results available
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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.

Conditions

  • Neuromuscular Blockade
  • Arthroplasty, Replacement, Hip
  • Arthroplasty, Replacement, Knee
  • Blood Coagulation
  • Antithrombotic Agents

Interventions

DRUG

Sugammadex

Sugammadex 4 mg/kg intravenously

DRUG

neostigmine and glycopyrrolate or atropine

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

DRUG

Placebo to neostigmine

Normal saline (NaCl 0.9%)

DRUG

Placebo to sugammadex

Normal saline (NaCl 0.9%)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-12
Primary Completion
2012-09-26
Completion
2012-09-26

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01422304 on ClinicalTrials.gov