Anesthesia, Surgery
Conditions
Keywords
Morbid obesity, Bariatric Surgery, Neuromuscular block reversal
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.
Interventions
DRUGSugammadex 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.
Sponsors
Assuta Hospital Systems
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Sugammadex reversal - number of drug-related adverse events with Sugammadex <= that of Neostigmine. | 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
| Measure | Time frame | Description |
|---|---|---|
| Use of Sugammadex for neuromuscular anaesthesia reversal higher patient satisfaction compared to Neostigmine. | 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. |
Countries
Israel
Outcome results
None listed