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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex vs. Neostigmine | Drug |
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| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Asnat Raziel, MD | Medical Director, ICBS-Israeli Center for Bariatric Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assuta Medical Center | Tel Aviv | Israel |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |