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

• ClinicalTrials.gov Identifier: NCT01761552
• Recruitment Status: Unknown
• First Posted: January 4, 2013
• Last Update Posted: September 10, 2013
• Sponsor: Hadassah Medical Organization
• Information provided by (Responsible Party): Hadassah Medical Organization

Study Description

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.)

Condition or disease	Intervention/treatment	Phase
Neuromuscular Blockade	Drug: Sugammadex Reversal; Drug: Atropine/Neostigmine	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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.
• Study Start Date: August 2013
• Estimated Primary Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sugammadex (tradename Bridion)	Drug: Sugammadex Reversal
Active Comparator: Traditional reversal or spontaneous recovery: 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.	Drug: Atropine/Neostigmine

Outcome Measures

Primary Outcome Measures :

1. Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred. [ Time Frame: 24 hours ]

Secondary Outcome Measures :

1. Time to extubation - measure the difference in time from application of the surgical dressing until extubation. [ Time Frame: 24 hours ]
2. 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.) [ Time Frame: 24 hours ]

Other Outcome Measures:

1. The effect of Sugammadex on cortisol levels [ Time Frame: 72 hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Hadas Lemberg, PhD; 00 972 2 6777572; lhadas@hadassah.org.il

Locations

Israel

Hadassah Medical Organization; Recruiting

Jerusalem, Israel, 91120

Principal Investigator: Yoram Weiss, MD

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

• Principal Investigator: Yoram G Weiss, MD; Hadassah Medical Organization

More Information

• Responsible Party: Hadassah Medical Organization
• ClinicalTrials.gov Identifier: NCT01761552
• Other Study ID Numbers: 0513-12-HMO
• First Posted: January 4, 2013
• Last Update Posted: September 10, 2013
• Last Verified: September 2012

Keywords provided by Hadassah Medical Organization:

in ASA 4 AND ASA 4E patients

Additional relevant MeSH terms:

Atropine; Neostigmine; Adjuvants, Anesthesia; Anti-Arrhythmia Agents; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Parasympatholytics; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinesterase Inhibitors; Enzyme Inhibitors; Parasympathomimetics