Efficacy and Safety of Org 25969 Administered After Zemuron® (MK-8616-042)

• Status: Completed
• Trial end date: 2005-05-26
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to explore the dose-response relation of MK-8616 (Org 25969) given as a reversal agent of Zemuron® at 1 to 2 post tetanic counts (PTCs); both Zemuron® and MK-8616 are administered by intravenous (iv) infusion. Another goal of the study is to evaluate the safety of single doses of MK-8616 administered to participants of American Society of Anesthesiologists (ASA) Physical Status Class 1 (otherwise normal, healthy participant); Class 2 (participant with a mild systemic disease); or Class 3 (participant with a severe systemic disease that limits activity, but is not incapacitating).

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

Details

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

Criteria

Inclusion Criteria:

• Has an ASA Class of 1 to 3

• Is scheduled for surgical procedures (excluding dental and neck surgeries) with an anticipated duration of anesthesia of ≥45 minutes with the use of Zemuron®

Exclusion Criteria:

• Is undergoing dental or neck surgery

• Has anatomical malformation that would impede intubation

• Has or is suspected to have neuromuscular disorders impairing neuromuscular block and/or significant renal dysfunction

• Is known or suspected to have a family history of malignant hyperthermia

• Is known or suspected to have an allergy to narcotics, muscle relaxants, or other medications used during general anesthesia

• Is pregnant

• Is a female of childbearing potential not using 1 of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner (<6 months), intrauterine device (IUD), or abstinence

• Is breast-feeding

• Has already participated in the study

• Has participated in another clinical trial, not pre-approved by Organon Pharmaceuticals USA within 30 days of entering this study