NCT00758485

Comparing 4.0 mg.Kg-1 Sugammadex With Placebo in the Reversal of Profound Neuromuscular Blockade (P05767)

A Randomized, Safety-assessor Blinded Trial Comparing 4.0 mg.Kg-1 Sugammadex With Placebo in Adult Subjects Scheduled for Surgery Requiring Profound Neuromuscular Blockade

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The current trial was designed to demonstrate faster recovery in participants undergoing elective surgeries requiring profound neuromuscular blockade induced by rocuronium to a fourth twitch/first twitch (T4/T1) ratio of 0.9, after reversal of a target depth of neuromuscular blockade (NMB) of 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1 Sugammadex compared to Placebo, to evaluate the safety of 4.0 mg.kg-1 Sugammadex and to evaluate the Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay for these participants.

Conditions

• Anesthesia
• Neuromuscular Blockade

Interventions

Type	Name	Description
DRUG	Sugammadex	At a target depth of NMB of 1-2 PTC after the last dose of rocuronium, a bolus dose of 4.0 mg.kg-1 sugammadex (volume based on the actual body weight of the participant) will be administered, within 10 seconds into a fast running venous infusion.
DRUG	0.9% sodium chloride (NaCl)	At a target depth of NMB of 1-2 PTC after the last dose of rocuronium, a bolus dose of placebo (0.9% NaCl, volume based on the actual body weight of the participant) will be administered, within 10 seconds into a fast running venous infusion.

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-05-01
• Completion: 2009-06-01
• First posted: 2008-09-25
• Last updated: 2015-08-21
• Results posted: 2013-04-22