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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	20 Years to 65 Years (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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Assuta Hospital Systems
ClinicalTrials.gov Identifier:	NCT01631396 History of Changes
Other Study ID Numbers:	AR-002-12
First Posted:	June 29, 2012
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