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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631396
• Other study ID #: AR-002-12
• Status: Completed
• Phase: N/A
• First received: June 14, 2012
• Last updated: June 24, 2014
• Start date: July 2012
• Est. completion date: May 2014

Study information

• Verified date: March 2012
• Source: Assuta Hospital Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia
• Surgery

Intervention

Drug:
• 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. 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.

Locations

Country	Name	City	State
Israel	Assuta Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Hospital Systems

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	No