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

Morbid Obesity Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01629394
• Other study ID #: 952/21-3-12
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: April 1, 2012
• Last updated: June 25, 2012
• Start date: January 2012
• Est. completion date: November 2012

Study information

• Verified date: June 2012
• Source: University of Patras
• Contact: Prokopios Georgiou, MD
• Phone: 00306973440348
• Email: prgeorg[@]yahoo.gr
• Is FDA regulated: No
• Health authority: Greece: Ethics CommitteeGreece: Ministry of Health and WelfareGreece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Neuromuscular Blockade
• Obesity, Morbid

Intervention

Drug:
• Sugammadex
Single dose of 2 mg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]
• Sugammadex
Single dose of sugammadex 2 mg/kg ( ideal body weight )
• Neostigmine
Single dose of neostigmine 50 µg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]
• Neostigmine
Single dose of neostigmine 50 µg/kg ( ideal body weight )
• Sugammadex
Single dose of 2 mg/kg corrected body weight [corrected body weight = ideal body weight + 40%( real body weight - ideal body weight)]
• Sugammadex
Single dose of sugammadex 2 mg/kg ( ideal body weight )
• Neostigmine
Single dose of neostigmine 50 µg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]
• Neostigmine
Single dose of neostigmine 50µg/kg ( ideal body weight )

Locations

Country	Name	City	State
Greece	University of Patras, Department of Anesthesiology and Critical Care Medicine	Patras	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes