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Comparison of Two Neuromuscular Anesthetics Reversal in Obese Patient Undergoing Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT01631396
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : June 25, 2014
Sponsor:
Information provided by (Responsible Party):
Assuta Hospital Systems

Study Description
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Brief Summary:
The study is a prospective, single center, double arm study aiming at the comparison of 2 commercial neuromuscular block reversal drugs: Neostigmine (Cooper S.A.) and Sugammadex (MSD). A faster recovery from neuromuscular block is expected for patients receiving Sugammadex and this protocol is of high importance for anesthesia of morbid obese patients during bariatric surgery.

Condition or disease Intervention/treatment
Anesthesia Surgery Drug: Sugammadex vs. Neostigmine

Study Design
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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Two Neuromuscular Anesthetics Reversal in Obese Patient Undergoing Bariatric Surgery
Study Start Date : July 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients recieving Sugammadex
Sugammadex Group (n=20) - anesthesia induced by Rocuronium 0.4mg/kg body, additional Rocuronium 0.1-0.2 mg/kg body as needed during surgery (not more than x2), muscular blockage reversal using Sugammadex 2.0 mg/kg body.
 Drug: Sugammadex vs. Neostigmine
  • Sugammadex Group (n=20) - anesthesia induced by Rocuronium 0.4mg/kg body, additional Rocuronium 0.1-0.2 mg/kg body as needed during surgery (not more than x2), muscular blockage reversal using Sugammadex 2.0 mg/kg body.
  • Neostigmine Group (n=20) - anesthesia induced by Rocuronium 0.4mg/kg body, additional Rocuronium 0.1-0.2 mg/kg body as needed during surgery (not more than x2), muscular blockage reversal using Neostigmine 0.05 mg/kg body and atropine 0.1 mg/kg body.
Patients recieving Neostigmine
Neostigmine Group (n=20) - anesthesia induced by Rocuronium 0.4mg/kg body, additional Rocuronium 0.1-0.2 mg/kg body as needed during surgery (not more than x2), muscular blockage reversal using Neostigmine 0.05 mg/kg body and atropine 0.1 mg/kg body.
 Drug: Sugammadex vs. Neostigmine
  • Sugammadex Group (n=20) - anesthesia induced by Rocuronium 0.4mg/kg body, additional Rocuronium 0.1-0.2 mg/kg body as needed during surgery (not more than x2), muscular blockage reversal using Sugammadex 2.0 mg/kg body.
  • Neostigmine Group (n=20) - anesthesia induced by Rocuronium 0.4mg/kg body, additional Rocuronium 0.1-0.2 mg/kg body as needed during surgery (not more than x2), muscular blockage reversal using Neostigmine 0.05 mg/kg body and atropine 0.1 mg/kg body.


Outcome Measures
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Primary Outcome Measures :
  1. Safety of Sugammadex reversal - number of drug-related adverse events with Sugammadex <= that of Neostigmine. [ Time Frame: Monitoring nueromuscular reaction from end of anesthesia recovery (in the OR) intil patient is released from hospital (48-72 h post surgery) ]
    The number of drug-related adverse events using Sugammadex is smaller or equal to those using Neostigmine.


Secondary Outcome Measures :
  1. Use of Sugammadex for neuromuscular anaesthesia reversal higher patient satisfaction compared to Neostigmine. [ Time Frame: Monitoring nueromuscular reaction from end of anesthesia recovery (in the OR) intil patient is released from hospital (48-72 h post surgery) ]
    Neuromuscular anesthesia reversal with Sugammdex is fast, comfortable and well accepted by the patients. Time of recovery from anesthesia and patient satisfaction will be compared for the two groups.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects for the study will be recruited from patients within the community who have sought treatment for morbid obesity by bariatric surgery, are qualified for the surgery and meet all of the eligibility criteria listed below.
Criteria

Inclusion Criteria:

  1. Morbidly obese male or female patients in the age 20-65 that are candidates for bariatric surgery.
  2. Patients that can read and understand the fundamental nature of the clinical protocol.
  3. Patients must sign the Informed Consent Form.

Exclusion Criteria:

  1. Patients treated with drugs that might interact with Rocuronium.
  2. Patients with history of malignant hyperthermia.
  3. Patients with significant renal disease.
  4. Patients with a known allergy to one of the drugs used during anesthesia.
  5. Patients with known muscular disease.
  6. Patients with severe cardiovascular disease (NYHA>2)
  7. Breast feeding patients
  8. Patients refusing to follow the clinical protocol.
  9. Patients participating in a different clinical trial.
  10. Patients refusing to sign the Informed Consent Form
  11. Physician's objection.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631396


Locations
Israel
Assuta Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Assuta Hospital Systems
Investigators
Principal Investigator: Asnat Raziel, MD Medical Director, ICBS-Israeli Center for Bariatric Surgery
More Information
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Responsible Party: Assuta Hospital Systems
ClinicalTrials.gov Identifier: NCT01631396     History of Changes
Other Study ID Numbers: AR-002-12
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: March 2012

Keywords provided by Assuta Hospital Systems:
Morbid obesity
Bariatric Surgery
Neuromuscular block reversal

Additional relevant MeSH terms:
Anesthetics
Rocuronium
Neostigmine
Central Nervous System Depressants
Physiological Effects of Drugs
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
 Peripheral Nervous System Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Parasympathomimetics
Autonomic Agents