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

Completed

• Conditions: Anesthesia; Surgery
• Interventions: Drug: Sugammadex vs. Neostigmine

• Registration Number: NCT01631396
• Lead Sponsor: Assuta Hospital Systems

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-03
• Study First Submitted: 2012-06-14
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-06-29
• Study Start: 2012-07
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-06-24
• Last Update Posted: 2014-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients recieving Sugammadex	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.
Patients recieving Neostigmine	Sugammadex vs. 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Assuta Medical Center; 🇮🇱 Tel Aviv, Israel