Clinical trial NCT01629394: Comparative Study of Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade in Morbidly Obese Patients
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Morbid Obesity
Neuromuscular Blockade
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Speed of reversal of neuromuscular blockade after administration of different sugammadex/neostigmine doses to TOF values = 0.9 in adductor pollicis and corrugator supercilii
timeFrame: TOF values for 2.5 h postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Patras
country: Greece
facility: University of Patras, Department of Anesthesiology and Critical Care Medicine
state: Achaia
Study officials:
affiliation: University Hospital of Patras
name: Prokopios S. Georgiou, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Patras, Dept. of Anaesthesiology and Critical Care Medicine
name: Kriton S. Filos, Professor
role: STUDY_CHAIR
affiliation: University Hospital of Patras
name: Athena Siampalioti, M.D.
role: STUDY_DIRECTOR
References: