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

Hadassah Medical Center

Status and phase: Unknown; Phase 4

Conditions: Neuromuscular Blockade

Treatments: Drug: Sugammadex Reversal; Drug: Atropine/Neostigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT01761552

0513-12-HMO

Details and patient eligibility

About

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.)

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Sugammadex (tradename Bridion)

Experimental group

Treatment:

Drug: Sugammadex Reversal

Traditional reversal or spontaneous recovery:

Active Comparator group

Description:

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.

Treatment:

Drug: Atropine/Neostigmine