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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anesthesia, Surgery

Intervention / Treatment
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* Drug: Sugammadex vs. Neostigmine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Morbidly obese male or female patients in the age 20-65 that are candidates for bariatric surgery. Patients that can read and understand the fundamental nature of the clinical protocol. Patients must sign the Informed Consent Form. Exclusion Criteria: Patients treated with drugs that might interact with Rocuronium. Patients with history of malignant hyperthermia. Patients with significant renal disease. Patients with a known allergy to one of the drugs used during anesthesia. Patients with known muscular disease. Patients with severe cardiovascular disease (NYHA>2) Breast feeding patients Patients refusing to follow the clinical protocol. Patients participating in a different clinical trial. Patients refusing to sign the Informed Consent Form Physician's objection.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients recieving Sugammadex<br>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<br>* 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.<br>|
| Patients recieving Neostigmine<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of Sugammadex for neuromuscular anaesthesia reversal higher patient satisfaction compared to Neostigmine. | 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. | Monitoring nueromuscular reaction from end of anesthesia recovery (in the OR) intil patient is released from hospital (48-72 h post surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbid obesity, Bariatric Surgery, Neuromuscular block reversal