Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023)

NCT ID: NCT00298831

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-27
• Study Completion Date: 2006-05-22

Brief Summary

The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio of 0.9 within 4 minutes after 4.0 mg.kg^-1 Sugammadex is administered at least 15 minutes after the last administration of rocuronium in a wide range of surgical procedures and anesthetic regimens (routine use). Safety evaluation is part of the study.

Conditions

Anesthesia, General

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sugammadex

Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg Org 25969 was administered.

Rocuronium

Intervention Type: DRUG

Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was/were administered.

Interventions

Sugammadex

At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg Org 25969 was administered.

Intervention Type: DRUG

Rocuronium

Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was/were administered.

Intervention Type: DRUG

Other Intervention Names

Org 25969; MK-8616

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists (ASA) Class 1-3 participants who are scheduled to undergo an elective surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium.

Exclusion Criteria

• Participants with neuromuscular disorders, significant renal dysfunction, malignant hyperthermia, allergy to medications used in general anesthesia and in whom difficult intubation is expected.
• Participants taking medications known to interfere with neuromuscular blocking agents.
• Participants who are of child-bearing potential, pregnant, and breast feeding

• 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

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Hudson ME, Rietbergen H, Chelly JE. Sugammadex is effective in reversing rocuronium in the presence of antibiotics. BMC Anesthesiol. 2014 Aug 15;14:69. doi: 10.1186/1471-2253-14-69. eCollection 2014.

Reference Type: DERIVED

PMID: 25157214 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Related Links

http://www.merck.com/clinical-trials/policies-perspectives.html

Click here to access a synopsis of the study results.

Other Identifiers

19.4.311

Identifier Type: OTHER

Identifier Source: secondary_id

P05943

Identifier Type: OTHER

Identifier Source: secondary_id

MK-8616-023

Identifier Type: OTHER

Identifier Source: secondary_id

P05943

Identifier Type: -

Identifier Source: org_study_id