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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Anesthesia
• Intervention / Treatment: Drug: Sugammadex vs. Neostigmine

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Assuta Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Assuta Hospital Systems
• Investigators: Principal Investigator: Asnat Raziel, MD, Medical Director, ICBS-Israeli Center for Bariatric Surgery

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: June 14, 2012
• First Submitted That Met QC Criteria: June 28, 2012
• First Posted (Estimate): June 29, 2012

Study Record Updates

• Last Update Posted (Estimate): June 25, 2014
• Last Update Submitted That Met QC Criteria: June 24, 2014
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Bariatric Surgery; Morbid obesity; Neuromuscular block reversal
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Parasympathomimetics; Neostigmine
• Other Study ID Numbers: AR-002-12