Comparative Study of Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade in Morbidly Obese Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Patras.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Prokopios Georgiou, University of Patras
ClinicalTrials.gov Identifier:
NCT01629394
First received: April 1, 2012
Last updated: June 25, 2012
Last verified: June 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Morbid
Obesity
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 October 16, 2014