Morbid Obesity, Neuromuscular Blockade
Conditions
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.
Interventions
DRUGSugammadex
Single dose of 2 mg/kg corrected body weight \[corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)\]
DRUGNeostigmine
Single dose of neostigmine 50 μg/kg corrected body weight \[corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)\]
Sponsors
University of Patras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
Greece
Contacts
Primary ContactProkopios Georgiou, MD
Backup ContactKriton S. Filos, MD PhD
Outcome results
None listed