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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

This study is not yet open for participant recruitment.
Verified September 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01761552
First received: December 20, 2012
Last updated: January 3, 2013
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Neuromuscular Blockade
 Drug: Sugammadex Reversal
Drug: Atropine/Neostigmine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: X-Rays
U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to extubation - measure the difference in time from application of the surgical dressing until extubation. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • The effect of Sugammadex on cortisol levels [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 130
Study Start Date: January 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761552

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

Locations
Israel
Hadassah Medical Organization Not yet 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

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01761552     History of Changes
Other Study ID Numbers: 0513-12-HMO
Study First Received: December 20, 2012
Last Updated: January 3, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
in ASA 4 AND ASA 4E patients

Additional relevant MeSH terms:
Atropine
Neostigmine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular 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

ClinicalTrials.gov processed this record on June 18, 2013