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

Phase 4

• Conditions: Neuromuscular Blockade
• Interventions: Drug: Sugammadex Reversal; Drug: Atropine/Neostigmine

• Registration Number: NCT01761552
• Lead Sponsor: Hadassah Medical Organization

Brief 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.)

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-09
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-04
• Study Start: 2013-08
• Last Update Submitted: 2013-09-08
• Last Update Posted: 2013-09-10
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• ASA 4 AND ASA 4E patients
• Patients scheduled to undergo any bowel, urogenital or orthopedic surgery under general anesthesia where use of neuromuscular blocking agents is indicated. -

Exclusion Criteria

• Patients ASA 1-3 or 5
• Patients who have a medical condition which precludes extubation at the end of surgery (i.e., mesenteric event, severe hypothermia etc.).
• Presence of an advanced directive to withhold or withdraw life sustaining treatment (i.e. DNR).
• Hypersensitivity to the active substances or to any of the excipients of medications used
• Patients with severe renal impairment (including patients requiring dialysis (CrCl < 30mL/min))
• Patients with severe hepatic impairment
• Age < 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugammadex (tradename Bridion)	Sugammadex Reversal	-
Traditional reversal or spontaneous recovery:	Atropine/Neostigmine	Atropine/Neostigmine: Atropine, 0.02 mg/ kg, and Neostigmine,0.05 mg/kg diluted in 100 ml Normal Saline and given over a 10 min drip. Reversal will be given only recommended if spontaneous recovery has occurred up to the reappearance of T2 (shallow blockade) following rocuronium induced blockade.

Primary Outcome Measures

Name	Time	Method
Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred.	24 hours

Secondary Outcome Measures

Name	Time	Method
Time to extubation - measure the difference in time from application of the surgical dressing until extubation.	24 hours
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.)	24 hours

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel