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

NCT ID: NCT01422304

Last Updated: 2021-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-12
• Study Completion Date: 2012-09-26

Brief 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.

Detailed Description

Participants will be randomized to sugammadex or usual care in a 1:1 ratio.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sugammadex

Prior to randomization, participants will be assigned to planned active reversal or planned spontaneous recovery by the anesthesiologist according to the recovery method the anesthesiologist would have chosen if the participant were not in the study. In this treatment arm, participants assigned to planned active reversal will receive sugammadex and placebo to neostigmine, and participants assigned to planned spontaneous recovery will receive sugammadex. Study drug will be administered after the last dose of rocuronium or vecuronium and after wound closure.

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Sugammadex 4 mg/kg intravenously

Placebo to neostigmine

Intervention Type: DRUG

Normal saline (NaCl 0.9%)

Usual Care

Prior to randomization, participants will be assigned to planned active reversal or planned spontaneous recovery by the anesthesiologist according to the recovery method the anesthesiologist would have chosen if the participant were not in the study. In this treatment arm, participants assigned to planned active reversal will receive neostigmine and placebo to sugammadex, and participants assigned to planned spontaneous recovery will receive placebo to sugammadex. Study drug will be administered after the last dose of rocuronium or vecuronium and after wound closure.

Group Type: EXPERIMENTAL

neostigmine and glycopyrrolate or atropine

Intervention Type: DRUG

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

Placebo to sugammadex

Intervention Type: DRUG

Normal saline (NaCl 0.9%)

Interventions

Sugammadex

Sugammadex 4 mg/kg intravenously

Intervention Type: DRUG

neostigmine and glycopyrrolate or atropine

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

Intervention Type: DRUG

Placebo to neostigmine

Normal saline (NaCl 0.9%)

Intervention Type: DRUG

Placebo to sugammadex

Normal saline (NaCl 0.9%)

Intervention Type: DRUG

Other Intervention Names

SCH 900616, MK-8616

Eligibility Criteria

Inclusion Criteria

• Must be American Society of Anesthesiologists (ASA) Class 1, 2, or 3
• Must be scheduled for a hip fracture surgery or joint (hip or knee) replacement surgery under general anesthesia including the use of rocuronium or vecuronium for neuromuscular blockade
• Must be:

• Currently receiving thromboprophylactic (anti-clotting) therapy with low molecular weight heparin (LMWH) or unfractionated heparin (UFH), or
• Planned to initiate thromboprophylactic therapy with LMWH or UFH prior to or during surgery, or
• Currently receiving ongoing thromboprophylactic therapy with a vitamin K antagonist that has been temporarily substituted with peri-operative LMWH or UFH, and/or
• Currently receiving ongoing thromboprophylactic therapy with low-dose aspirin or other antiplatelet therapy
• Platelet count above the lower limit of normal range
• Appropriate candidate for rapid reversal of neuromuscular blockade
• Sexually active females must agree to use a medically accepted method of contraception through seven days after receiving protocol-specified medication

Exclusion Criteria

• Anatomical malformations that may lead to difficult intubation
• Neuromuscular disorder that may affect neuromuscular blockade
• History of a coagulation disorder, bleeding diathesis, systemic lupus erythematosus or antiphospholipid syndrome
• History or evidence of active abnormal bleeding or blood clotting within 30 days prior to screening
• Significant hepatic dysfunction
• Severe renal insufficiency
• History or family history of malignant hyperthermia
• Hypersensitivity or hypersensitivity-like reaction to sugammadex, muscle relaxants, or other medications used during general anesthesia
• Planned intravenous administration of toremifene and/or fusidic acid within 24 hours before or within 24 hours after study medication
• Recent, severe trauma
• Body Mass Index (BMI) > 35
• Any contraindication to administration of sugammadex or neostigmine/glycopyrrolate (or neostigmine/atropine)
• Pregnant or intends to become pregnant between randomization and the Day 30 follow-up visit
• Breast-feeding
• Previously treated with sugammadex or participated in a sugammadex clinical trial
• Has an active hip/knee infection and is scheduled for revision surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Rahe-Meyer N, Fennema H, Schulman S, Klimscha W, Przemeck M, Blobner M, Wulf H, Speek M, McCrary Sisk C, Williams-Herman D, Woo T, Szegedi A. Effect of reversal of neuromuscular blockade with sugammadex versus usual care on bleeding risk in a randomized study of surgical patients. Anesthesiology. 2014 Nov;121(5):969-77. doi: 10.1097/ALN.0000000000000424.

Reference Type: RESULT

PMID: 25208233 (View on PubMed)

Other Identifiers

2011-001201-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-8616-059

Identifier Type: OTHER

Identifier Source: secondary_id

P07038

Identifier Type: -

Identifier Source: org_study_id