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
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Condition or disease | Intervention/treatment |
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Anesthesia Surgery | Drug: Sugammadex vs. Neostigmine |
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 |
Group/Cohort | Intervention/treatment |
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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.
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Drug: Sugammadex vs. Neostigmine
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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.
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Drug: Sugammadex vs. Neostigmine
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- 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.
- 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.

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Ages Eligible for Study: | 20 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

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
Israel | |
Assuta Medical Center | |
Tel Aviv, Israel |
Principal Investigator: | Asnat Raziel, MD | Medical Director, ICBS-Israeli Center for Bariatric Surgery |
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 |