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

University of Patras

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Morbid Obesity

Neuromuscular Blockade

Treatments

Drug: Neostigmine

Drug: Sugammadex

Study type

Interventional

Funder types

Other

Identifiers

NCT01629394

952/21-3-12

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 8 patient groups

Group A: Sugammadex CBW-open

Active Comparator group

Description:

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.

Treatment:

Drug: Sugammadex

Group B: Sugammadex IBW-open

Active Comparator group

Description:

Group B patients will undergo open surgery and will receive sugammadex 2mg/kg ( ideal body weight ) when T2 arises in adductor pollicis.

Treatment:

Drug: Sugammadex

Group C: Neostigmine CBW-open

Active Comparator group

Description:

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.

Treatment:

Drug: Neostigmine

Group D: Neostigmine-IBW

Active Comparator group

Description:

Group D patients will undergo open surgery and will receive neostigmine 50μg/kg ( ideal body weight ) when T2 arises in adductor pollicis.

Treatment:

Drug: Neostigmine

Group E: Sugammadex CBW-Lap

Active Comparator group

Description:

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.

Treatment:

Drug: Sugammadex

Group F: Sugammadex IBW-Lap

Active Comparator group

Description:

Group F patients will undergo laparoscopic surgery and will receive sugammadex 2mg/kg ( ideal body weight ) when T2 arises in adductor pollicis.

Treatment:

Drug: Sugammadex

Group G: Neostigmine CBW-Lap

Active Comparator group

Description:

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.

Treatment:

Drug: Neostigmine

Group H: Neostigmine IBW-Lap

Active Comparator group

Description:

Group D patients will undergo open surgery and will receive neostigmine 50μg/kg ( ideal body weight ) when T2 arises in adductor pollicis.

Treatment:

Drug: Neostigmine