NCT01629394

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.

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Patras · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Morbid Obesity
• Neuromuscular Blockade

Interventions

Type	Name	Description
DRUG	Sugammadex	Single dose of 2 mg/kg corrected body weight \[corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)\]
DRUG	Sugammadex	Single dose of sugammadex 2 mg/kg ( ideal body weight )
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	Sugammadex	Single dose of 2 mg/kg corrected body weight \[corrected body weight = ideal body weight + 40%( real body weight - ideal body weight)\]
DRUG	Sugammadex	Single dose of sugammadex 2 mg/kg ( ideal body weight )
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 50μg/kg ( ideal body weight )

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-10-01
• Completion: 2012-11-01
• First posted: 2012-06-27
• Last updated: 2012-06-27

Locations

1 site across 1 country: Greece