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

NCT01631396 | Completed

• 1 other identifier: AR-002-12
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Surgery

Keywords

Morbid obesity; Bariatric Surgery; Neuromuscular block reversal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

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

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

Interventions

Sugammadex vs. Neostigmine DRUG

* 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; Patients recieving Sugammadex

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Morbidly obese male or female patients in the age 20-65 that are candidates for bariatric surgery.
• Patients that can read and understand the fundamental nature of the clinical protocol.
• Patients must sign the Informed Consent Form.

You may not qualify if:

• Patients treated with drugs that might interact with Rocuronium.
• Patients with history of malignant hyperthermia.
• Patients with significant renal disease.
• Patients with a known allergy to one of the drugs used during anesthesia.
• Patients with known muscular disease.
• Patients with severe cardiovascular disease (NYHA\>2)
• Breast feeding patients
• Patients refusing to follow the clinical protocol.
• Patients participating in a different clinical trial.
• Patients refusing to sign the Informed Consent Form
• Physician's objection.

Sponsors & Collaborators

• Assuta Hospital Systems: lead

Study Sites (1)

Assuta Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Asnat Raziel, MD

  Medical Director, ICBS-Israeli Center for Bariatric Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: June 29, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 25, 2014

Record last verified: 2012-03

Locations

IL (1)