Comparative Study of Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade in Morbidly Obese Patients - Full Text View

Purpose

Postoperative residual curarization in the post anaesthesia unit has been associated to complications involving respiratory function and impaired laryngeal and pharyngeal muscles' function. Speed of reversal of neuromuscular blockade after administration of sugammadex versus neostigmine has been studied, but up to date no data are available concerning continuous acceleromyography monitoring of adductor pollicis and corrugator supercilii in morbidly obese patients undergoing weight loss surgery. The investigators' aim in this prospective, double-blinded study was to compare train of four ( TOF ) values, the presence or absence of clinical criteria of postoperative residual curarization , the dose requirements and the side effects of sugammadex and neostigmine for the reversal of rocuronium induced neuromuscular blockade in patients undergoing laparoscopic or open surgery for morbid obesity.

Condition	Intervention	Phase
Morbid Obesity Neuromuscular Blockade	Drug: Sugammadex Drug: Neostigmine	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Comparative Study of Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade in Morbidly Obese Patients Undergoing Weight Loss Surgery.Use of Acceleromyography Monitoring in Adductor Pollicis and Corrugator Supercilii.

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control Weight Loss Surgery

Drug Information available for: Neostigmine methylsulfate

U.S. FDA Resources

Further study details as provided by University of Patras:

Primary Outcome Measures:

Speed of reversal of neuromuscular blockade after administration of different sugammadex/neostigmine doses to TOF values = 0.9 in adductor pollicis and corrugator supercilii [ Time Frame: TOF values for 2.5 h postoperatively ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	January 2012
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Group A: Sugammadex CBW-open Group A patients will undergo open surgery and will receive sugammadex 2mg/kg corrected body weight [corrected body weight = ideal body weight + 40%( real body weight - ideal body weight)] when T2 arises in adductor pollicis.	Drug: Sugammadex Single dose of 2 mg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)] Other Name: Bridion(R)
Active Comparator: Group B: Sugammadex IBW-open Group B patients will undergo open surgery and will receive sugammadex 2mg/kg ( ideal body weight ) when T2 arises in adductor pollicis.	Drug: Sugammadex Single dose of sugammadex 2 mg/kg ( ideal body weight ) Other Name: Bridion(R)
Active Comparator: Group C: Neostigmine CBW-open Group C patients will undergo open surgery and will receive neostigmine 50μg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]when T2 arises in adductor pollicis.	Drug: Neostigmine Single dose of neostigmine 50 μg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)] Other Name: Neostigmine
Active Comparator: Group D: Neostigmine-IBW Group D patients will undergo open surgery and will receive neostigmine 50μg/kg ( ideal body weight ) when T2 arises in adductor pollicis.	Drug: Neostigmine Single dose of neostigmine 50 μg/kg ( ideal body weight ) Other Name: Neostigmine
Active Comparator: Group E: Sugammadex CBW-Lap Group E patients will undergo laparoscopic surgery and will receive sugammadex 2mg/kg corrected body weight [corrected body weight = ideal body weight + 40%( real body weight - ideal body weight)] when T2 arises in adductor pollicis.	Drug: Sugammadex Single dose of 2 mg/kg corrected body weight [corrected body weight = ideal body weight + 40%( real body weight - ideal body weight)] Other Name: Bridion(R)
Active Comparator: Group F: Sugammadex IBW-Lap Group F patients will undergo laparoscopic surgery and will receive sugammadex 2mg/kg ( ideal body weight ) when T2 arises in adductor pollicis.	Drug: Sugammadex Single dose of sugammadex 2 mg/kg ( ideal body weight ) Other Name: Bridion(R)
Active Comparator: Group G: Neostigmine CBW-Lap Group C patients will undergo laparoscopic surgery and will receive neostigmine 50μg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]when T2 arises in adductor pollicis.	Drug: Neostigmine Single dose of neostigmine 50 μg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)] Other Name: Neostigmine
Active Comparator: Group H: Neostigmine IBW-Lap Group D patients will undergo open surgery and will receive neostigmine 50μg/kg ( ideal body weight ) when T2 arises in adductor pollicis.	Drug: Neostigmine Single dose of neostigmine 50μg/kg ( ideal body weight ) Other Name: Neostigmine

Detailed Description:

Morbidly obese patients [ body mass index (BMI) > 40 kg/m2 ] planned to undergo open or laparoscopic surgery for weight loss will be managed with standardized general anesthesia (intravenous Propofol combined with remifentanil and muscle relaxation induced by rocuronium).

By the end of the surgery, Group A and group E patients will receive sugammadex 2 mg/kg corrected body weight [corrected body weight(CBW)=ideal body weight(IBW) + 40%(real body weight(RBW)-ideal body weight)] when T2 arises in adductor pollicis. Group C and group G will receive neostigmine 50μg/kg corrected body weight when T2 arises in adductor pollicis. Group B and group F patients will receive sugammadex 2 mg/kg ideal body weight when T2 arises in adductor pollicis. Group D and group H patients will receive 50μg/kg neostigmine ideal body weight.

Investigators will proceed in continuous acceleromyography monitoring of adductor pollicis and corrugator supercilii during induction of anaesthesia, surgery, recovery and in the post anaesthesia care unit, recording TOF values. Total consumption of neuromuscular blocking agent, doses of reversal agents and clinical criteria of post operation residual curarization will also be recorded.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Body mass index (BMI) >40kg
Age < 60
Patients written consent to participate in the study

Exclusion Criteria:

Cardiovascular disease (NYHA>2)
Patients refusal to participate in the study
Contraindication to epidural catheter placement (e.g anticoagulation, anti- platelets medication)
coexisting neuromuscular disease
history of allergic reaction to neuromuscular blocking agents
history of difficult intubation
creatinine levels > 159lmol/l

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629394

Contacts

Contact: Prokopios Georgiou, MD	00306973440348	prgeorg@yahoo.gr
Contact: Kriton S. Filos, MD PhD	00302610999341	kritonfilos@yahoo.gr

Locations

Greece
University of Patras, Department of Anesthesiology and Critical Care Medicine	Recruiting
Patras, Achaia, Greece, 26500
Contact: Kriton S. Filos, MD PhD 00302610999341 kritonfilos@yahoo.gr

Sponsors and Collaborators

University of Patras

Investigators

Principal Investigator:	Prokopios S. Georgiou, M.D.	University Hospital of Patras
Study Chair:	Kriton S. Filos, Professor	University of Patras, Dept. of Anaesthesiology and Critical Care Medicine
Study Director:	Athena Siampalioti, M.D.	University Hospital of Patras

More Information

No publications provided

Responsible Party:	Prokopios Georgiou, Prokopios Georgiou M.D., University of Patras
ClinicalTrials.gov Identifier:	NCT01629394 History of Changes
Other Study ID Numbers:	952/21-3-12
Study First Received:	April 1, 2012
Last Updated:	June 25, 2012
Health Authority:	Greece: Ethics Committee Greece: Ministry of Health and Welfare Greece: National Organization of Medicines

Additional relevant MeSH terms:

Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Neostigmine
Cholinesterase Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013