Comparing 4.0 mg.Kg-1 Sugammadex With Placebo in the Reversal of Profound Neuromuscular Blockade (P05767)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Neuromuscular Blockade; Anesthesia

Treatments: Drug: Sugammadex; Drug: 0.9% sodium chloride (NaCl)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00758485

P05767

19.4.316 (Other Identifier)

2008-002518-23 (EudraCT Number)

MK-8616-004 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups, including a placebo group

sugammadex

Experimental group

Description:

Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium

Treatment:

Drug: Sugammadex

Placebo

Placebo Comparator group

Description:

Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium

Treatment:

Drug: 0.9% sodium chloride (NaCl)