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

Phase 2

• Conditions: Morbid Obesity; Neuromuscular Blockade
• Interventions: Drug: Neostigmine; Drug: Sugammadex

• Registration Number: NCT01629394
• Lead Sponsor: University of Patras

Brief Summary

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.

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-04-01
• Status Verified: 2012-06
• Study First Submitted QC: 2012-06-25
• Last Update Submitted: 2012-06-25
• Study First Posted: 2012-06-27
• Last Update Posted: 2012-06-27
• Primary Completion: 2012-10
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C: Neostigmine CBW-open	Neostigmine	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.
Group D: Neostigmine-IBW	Neostigmine	Group D patients will undergo open surgery and will receive neostigmine 50μg/kg ( ideal body weight ) when T2 arises in adductor pollicis.
Group B: Sugammadex IBW-open	Sugammadex	Group B patients will undergo open surgery and will receive sugammadex 2mg/kg ( ideal body weight ) when T2 arises in adductor pollicis.
Group A: Sugammadex CBW-open	Sugammadex	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.
Group E: Sugammadex CBW-Lap	Sugammadex	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.
Group F: Sugammadex IBW-Lap	Sugammadex	Group F patients will undergo laparoscopic surgery and will receive sugammadex 2mg/kg ( ideal body weight ) when T2 arises in adductor pollicis.
Group G: Neostigmine CBW-Lap	Neostigmine	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.
Group H: Neostigmine IBW-Lap	Neostigmine	Group D patients will undergo open surgery and will receive neostigmine 50μg/kg ( ideal body weight ) when T2 arises in adductor pollicis.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Patras, Department of Anesthesiology and Critical Care Medicine; 🇬🇷 Patras, Achaia, Greece