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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Morbid Obesity; Neuromuscular Blockade
• Intervention / Treatment: Drug: Sugammadex; Drug: Sugammadex; Drug: Sugammadex; Drug: Neostigmine; Drug: Neostigmine; Drug: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Bridion(R); Drug: Sugammadex; Single dose of sugammadex 2 mg/kg ( ideal body weight ); Other Names: Bridion(R); 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 Names: 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 2 mg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]; Other Names: Bridion(R); Drug: Sugammadex; Single dose of sugammadex 2 mg/kg ( ideal body weight ); Other Names: Bridion(R); 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 Names: 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)]; Drug: Neostigmine; Single dose of neostigmine 50 μg/kg ( ideal body weight ); Drug: Neostigmine; Single dose of neostigmine 50μg/kg ( ideal body weight )
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 corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]; Drug: Neostigmine; Single dose of neostigmine 50 μg/kg ( ideal body weight ); Drug: Neostigmine; Single dose of neostigmine 50μg/kg ( ideal body weight )
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 Names: Bridion(R); Drug: Sugammadex; Single dose of sugammadex 2 mg/kg ( ideal body weight ); Other Names: Bridion(R); 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 Names: 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 2 mg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]; Other Names: Bridion(R); Drug: Sugammadex; Single dose of sugammadex 2 mg/kg ( ideal body weight ); Other Names: Bridion(R); 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 Names: 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)]; Drug: Neostigmine; Single dose of neostigmine 50 μg/kg ( ideal body weight ); Drug: Neostigmine; Single dose of neostigmine 50μg/kg ( ideal body weight )
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 50 μg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]; Drug: Neostigmine; Single dose of neostigmine 50 μg/kg ( ideal body weight ); Drug: Neostigmine; Single dose of neostigmine 50μg/kg ( ideal body weight )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Speed of reversal of neuromuscular blockade after administration of different sugammadex/neostigmine doses to TOF values = 0.9 in adductor pollicis and corrugator supercilii	TOF values for 2.5 h postoperatively

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ANTICIPATED): October 1, 2012
• Study Completion (ANTICIPATED): November 1, 2012

Study Registration Dates

• First Submitted: April 1, 2012
• First Submitted That Met QC Criteria: June 25, 2012
• First Posted (ESTIMATE): June 27, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 27, 2012
• Last Update Submitted That Met QC Criteria: June 25, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid; 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: 952/21-3-12