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

Primary Purpose

Morbid Obesity, Neuromuscular Blockade

Status

Unknown status

Phase

Phase 2

Locations

Greece

Study Type

Interventional

Intervention

Sugammadex

Neostigmine

Sugammadex

Neostigmine

About this trial

This is an interventional treatment trial for Morbid Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

University of Patras, Department of Anesthesiology and Critical Care MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Arm Label

Group A: Sugammadex CBW-open

Group B: Sugammadex IBW-open

Group C: Neostigmine CBW-open

Group D: Neostigmine-IBW

Group E: Sugammadex CBW-Lap

Group F: Sugammadex IBW-Lap

Group G: Neostigmine CBW-Lap

Group H: Neostigmine IBW-Lap

Arm 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.

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

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.

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

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.

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

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.

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

Outcomes

Primary Outcome Measures

Speed of reversal of neuromuscular blockade after administration of different sugammadex/neostigmine doses to TOF values = 0.9 in adductor pollicis and corrugator supercilii

Secondary Outcome Measures

Full Information

NCT ID

NCT01629394

First Posted

April 1, 2012

Last Updated

June 25, 2012

Sponsor

University of Patras

1. Study Identification

Unique Protocol Identification Number

NCT01629394

Brief Title

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

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

October 2012 (Anticipated)

Study Completion Date

November 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Patras

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Morbid Obesity, Neuromuscular Blockade

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A: Sugammadex CBW-open

Arm Type

Active Comparator

Arm Description

Arm Title

Group B: Sugammadex IBW-open

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group C: Neostigmine CBW-open

Arm Type

Active Comparator

Arm Description

Arm Title

Group D: Neostigmine-IBW

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group E: Sugammadex CBW-Lap

Arm Type

Active Comparator

Arm Description

Arm Title

Group F: Sugammadex IBW-Lap

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group G: Neostigmine CBW-Lap

Arm Type

Active Comparator

Arm Description

Arm Title

Group H: Neostigmine IBW-Lap

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sugammadex

Other Intervention Name(s)

Bridion(R)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sugammadex

Other Intervention Name(s)

Bridion(R)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Neostigmine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Neostigmine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sugammadex

Other Intervention Name(s)

Bridion(R)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sugammadex

Other Intervention Name(s)

Bridion(R)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Neostigmine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Neostigmine

Intervention Description

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

Primary Outcome Measure Information:

Title

Speed of reversal of neuromuscular blockade after administration of different sugammadex/neostigmine doses to TOF values = 0.9 in adductor pollicis and corrugator supercilii

Time Frame

TOF values for 2.5 h postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Prokopios Georgiou, MD

Phone

00306973440348

prgeorg@yahoo.gr

First Name & Middle Initial & Last Name or Official Title & Degree

Kriton S. Filos, MD PhD

Phone

00302610999341

kritonfilos@yahoo.gr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prokopios S. Georgiou, M.D.

Organizational Affiliation

University Hospital of Patras

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kriton S. Filos, Professor

Organizational Affiliation

University of Patras, Dept. of Anaesthesiology and Critical Care Medicine

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Athena Siampalioti, M.D.

Organizational Affiliation

University Hospital of Patras

Official's Role

Study Director

Facility Information:

Facility Name

University of Patras, Department of Anesthesiology and Critical Care Medicine

City

Patras

State/Province

Achaia

ZIP/Postal Code

26500

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kriton S. Filos, MD PhD

Phone

00302610999341

kritonfilos@yahoo.gr

12. IPD Sharing Statement

Learn more about this trial

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

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