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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assuta Hospital Systems
ClinicalTrials.gov Identifier:
NCT01631396
First received: June 14, 2012
Last updated: June 24, 2014
Last verified: March 2012
  Purpose

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 Intervention
Anesthesia
Surgery
Drug: Sugammadex vs. Neostigmine

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Two Neuromuscular Anesthetics Reversal in Obese Patient Undergoing Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by Assuta Hospital Systems:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    The number of drug-related adverse events using Sugammadex is smaller or equal to those using Neostigmine.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: July 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Assuta Hospital Systems
ClinicalTrials.gov Identifier: NCT01631396     History of Changes
Other Study ID Numbers: AR-002-12
Study First Received: June 14, 2012
Last Updated: June 24, 2014
Health Authority: Israel: Ethics Commission

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

Additional relevant MeSH terms:
Anesthetics
Neostigmine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014