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

NCT ID: NCT01050543

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-01
• Study Completion Date: 2010-08-20

Brief Summary

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.

Conditions

Neuromuscular Blockade

Study Design

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

Study Groups

Sugammadex

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

sugammadex 2.0 mg/kg, single intravenous bolus dose administered within 10 seconds into a fast flowing venous infusion

Neostigmine

Group Type: ACTIVE_COMPARATOR

neostigmine

Intervention Type: DRUG

neostigmine 50 mcg/kg (total dose not to exceed 5.0 mg) combined with glycopyrrolate 10 mcg/kg, single intravenous bolus dose administered within 10 seconds into a fast flowing venous infusion

Interventions

sugammadex

sugammadex 2.0 mg/kg, single intravenous bolus dose administered within 10 seconds into a fast flowing venous infusion

Intervention Type: DRUG

neostigmine

neostigmine 50 mcg/kg (total dose not to exceed 5.0 mg) combined with glycopyrrolate 10 mcg/kg, single intravenous bolus dose administered within 10 seconds into a fast flowing venous infusion

Intervention Type: DRUG

Other Intervention Names

SCH 900616; Bridion; neostigmine methylsulfate

Eligibility Criteria

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

• 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

Woo T, Kim KS, Shim YH, Kim MK, Yoon SM, Lim YJ, Yang HS, Phiri P, Chon JY. Sugammadex versus neostigmine reversal of moderate rocuronium-induced neuromuscular blockade in Korean patients. Korean J Anesthesiol. 2013 Dec;65(6):501-7. doi: 10.4097/kjae.2013.65.6.501. Epub 2013 Dec 26.

Reference Type: RESULT

PMID: 24427455 (View on PubMed)

Other Identifiers

P06101

Identifier Type: -

Identifier Source: org_study_id