NCT01761552

A Prospective, Randomized Controlled Trial Comparing Traditional Methods of Neuromuscular Block Reversal to Sugammadex for Extubation in the Operating Room in ASA 4 and 4E Patients

A Prospective, Randomized Controlled Trial Comparing Traditional Methods of Neuromuscular Block Reversal to Sugammadex for Extubation in the Operating Room in ASA 4 and 4E Patients.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate that the use of Sugammadex enables physicians to perform early extubation in the operating room in ASA 4 \& 4E patients Primary endpoint: • Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred. Secondary endpoints: • Time to extubation - measure the difference in time from application of the surgical dressing until extubation. Atelectasis - comparison of chest x-rays (CXR): prior to surgery, on admission to PACU or ICU and 24 hours after admission to PACU or ICU (This is the routine practice at Hadassa hospital for ASA IV patients.)

Conditions

• Neuromuscular Blockade

Interventions

Type	Name	Description
DRUG	Sugammadex Reversal
DRUG	Atropine/Neostigmine

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-12-01
• First posted: 2013-01-04
• Last updated: 2013-09-10

Locations

1 site across 1 country: Israel