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

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.

Conditions

• Morbid Obesity
• Neuromuscular Blockade

Interventions

DRUG

Sugammadex

Single dose of 2 mg/kg corrected body weight \[corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)\]

DRUG

Sugammadex

Single dose of sugammadex 2 mg/kg ( ideal body weight )

DRUG

Neostigmine

Single dose of neostigmine 50 μg/kg corrected body weight \[corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)\]

DRUG

Neostigmine

Single dose of neostigmine 50 μg/kg ( ideal body weight )

DRUG

Sugammadex

Single dose of 2 mg/kg corrected body weight \[corrected body weight = ideal body weight + 40%( real body weight - ideal body weight)\]

DRUG

Sugammadex

Single dose of sugammadex 2 mg/kg ( ideal body weight )

DRUG

Neostigmine

Single dose of neostigmine 50 μg/kg corrected body weight \[corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)\]

DRUG

Neostigmine

Single dose of neostigmine 50μg/kg ( ideal body weight )

Sponsors & Collaborators

• University of Patras

  lead OTHER

Principal Investigators

• Prokopios S. Georgiou, M.D. · University Hospital of Patras

• Kriton S. Filos, Professor · University of Patras, Dept. of Anaesthesiology and Critical Care Medicine

• Athena Siampalioti, M.D. · University Hospital of Patras

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2012-10-31

Completion

2012-11-30

Countries

• Greece

Study Locations