Efficacy, Safety and Pharmacokinetics of Sugammadex (Org 25969; MK-8616) at 3 Different Time Points After 0.6 mg/kg Esmeron® in Male Participants (P05940; MK-8616-020).

• Status: Completed
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study investigates the efficacy, safety, and pharmacokinetics of sugammadex (Org 25969; MK-8616) when administered for the reversal of neuromuscular blockade in male participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant) to class 2 (participant with mild systemic disease). The primary objective of this study is to explore the dose-response relation of sugammadex given as a reversal agent at 3, 5, or 15 minutes following administration of 0.6 mg/kg Esmeron®.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Bromides; Rocuronium

Criteria

Inclusion Criteria:

• Participants of ASA class 1 to 2.

• Participants scheduled for surgical procedures with an anticipated duration of anesthesia of at least 75 minutes, without further need for muscle relaxation other than for intubation.

Exclusion Criteria:

• Participants in whom a difficult intubation because of anatomical malformations is expected.

• Participants known or suspected to have neuromuscular disorders and/or significant hepatic or renal dysfunction.

• Participants known or suspected to have a (family) history of malignant hyperthermia.

• Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia.

• Participants receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, aminoglycosides, and Mg^2+.

• Participants who have already participated in this trial.

• Participants who have participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into this trial.