Comparison of Sugammadex With Neostigmine as Reversal Agents for Rocuronium at Reappearance of T2 (Study P06101) (DANCHEONG)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Neuromuscular Blockade

Treatments: Drug: neostigmine; Drug: sugammadex

Study type: Interventional

Funder types: Industry

Identifiers

NCT01050543

P06101

Details and patient eligibility

About

This is a randomized, active-controlled, parallel-group, single-dose, multi-site, safety-assessor blinded study comparing sugammadex to neostigmine for reversal of neuromuscular blockade in Korean subjects undergoing elective surgical procedures under general anesthesia that require rocuronium for neuromuscular blockade. Study medication will be administered at reappearance of T2. Time to recovery will be measured from start of study medication administration to recovery of the T4/T1 ratio of 0.9. The primary hypothesis is that the time to recovery of the T4/T1 ratio of 0.9 is shorter with sugammadex than with neostigmine.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists Class 1 or 2 or 3
• >=18 years of age and of either sex
• scheduled for elective surgical procedure under general anesthesia requiring the use of rocuronium for endotracheal intubation and/or maintenance of neuromuscular blockade in a supine position allowing neuromuscular transmission monitoring and requiring reversal of neuromuscular blockade
• Korean descent born in Korea, never emigrated out of Korea, and have a Korean home address

Exclusion criteria

• expected difficult intubation due to anatomic malformations
• expected transfer to intensive care unit after surgery
• neuromuscular disorders affecting neuromuscular blockade
• significant hepatic or renal dysfunction
• require use of pneumatic tourniquet during surgery
• (family) history of malignant hyperthermia
• allergy to cyclodextrins (including sugammadex) or other medication(s) used during general anesthesia; use of toremifene or fusidic acid within 24 hours of study drug administration; contraindication to use of neostigmine or glycopyrrolate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

Sugammadex

Experimental group

Treatment:

Drug: sugammadex

Neostigmine

Active Comparator group

Treatment:

Drug: neostigmine