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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Morbid Obesity, Neuromuscular Blockade

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Sugammadex
* Drug: Neostigmine
* Drug: Neostigmine
* Drug: Sugammadex
* Drug: Sugammadex
* Drug: Neostigmine
* Drug: Neostigmine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A: Sugammadex CBW-open<br>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<br>* Single dose of 2 mg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]<br>* Other names: Bridion(R);|
| Active Comparator: Group B: Sugammadex IBW-open<br>Group B patients will undergo open surgery and will receive sugammadex 2mg/kg ( ideal body weight ) when T2 arises in adductor pollicis. | Drug: Sugammadex<br>* Single dose of sugammadex 2 mg/kg ( ideal body weight )<br>* Other names: Bridion(R);|
| Active Comparator: Group C: Neostigmine CBW-open<br>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<br>* Single dose of neostigmine 50 μg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]<br>|
| Active Comparator: Group D: Neostigmine-IBW<br>Group D patients will undergo open surgery and will receive neostigmine 50μg/kg ( ideal body weight ) when T2 arises in adductor pollicis. | Drug: Neostigmine<br>* Single dose of neostigmine 50 μg/kg ( ideal body weight )<br>|
| Active Comparator: Group E: Sugammadex CBW-Lap<br>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<br>* Single dose of 2 mg/kg corrected body weight [corrected body weight = ideal body weight + 40%( real body weight - ideal body weight)]<br>* Other names: Bridion(R);|
| Active Comparator: Group F: Sugammadex IBW-Lap<br>Group F patients will undergo laparoscopic surgery and will receive sugammadex 2mg/kg ( ideal body weight ) when T2 arises in adductor pollicis. | Drug: Sugammadex<br>* Single dose of sugammadex 2 mg/kg ( ideal body weight )<br>* Other names: Bridion(R);|
| Active Comparator: Group G: Neostigmine CBW-Lap<br>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<br>* Single dose of neostigmine 50 μg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]<br>|
| Active Comparator: Group H: Neostigmine IBW-Lap<br>Group D patients will undergo open surgery and will receive neostigmine 50μg/kg ( ideal body weight ) when T2 arises in adductor pollicis. | Drug: Neostigmine<br>* Single dose of neostigmine 50μg/kg ( ideal body weight )<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |