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.

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Key information

Conditions

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

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assuta Medical Center

Tel Aviv, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

Safety of Sugammadex reversal - number of drug-related adverse events with Sugammadex <= that of Neostigmine.

Time frame: 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 outcomes

Use of Sugammadex for neuromuscular anaesthesia reversal higher patient satisfaction compared to Neostigmine.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assuta Hospital Systems

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Jun 29, 2012
Registry last updated: Jun 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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