Efficacy of Low Dose Sugammadex in Reversal of NMB in Lap... | NCT02713113

Studies
Efficacy of Low Dose Sugammadex in Reversal of NMB in Laparoscopic Barbaric Surgery

NCT02713113

Sponsor

Assiut University

Status

Completed

Last Update Posted

Mar 21, 2016Estimated

Enrollment

180Actual

Phase

Phase 3

Conditions

Bariatric Patients

Interventions

sugammadex reversal of neuromuscular blockade

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Feb 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Mar 15, 2016

First Submission Date that Met QC Criteria

Mar 15, 2016

First Posted Date

Mar 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2016

Last Update Posted Date

Mar 21, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

the investigators aimed to compare the efficacy and safety of sugammadex at doses of 1.5, 2, and 4 mg/ kg for the reversal of moderate rocuronium-induced neuromuscular blockade in laparoscopic bariatric surgery.

Detailed Description

Patients were randomly assigned using a randomization-computer program into three groups according to the dose of sugammadex administrated (according to the IBW after T2 of TOF):

Group I: patients were given 1.5 mg / kg. Group II: patients were given 2 mg / kg. Group III: patients were given 4 mg / kg.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group 1	Active Comparator	patients were given 1.5 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)	Drug: sugammadex reversal of neuromuscular blockade
group II	Active Comparator	patients were given 2 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)	Drug: sugammadex reversal of neuromuscular blockade
group III	Active Comparator	patients were given 4 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)	Drug: sugammadex reversal of neuromuscular blockade

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sugammadex reversal of neuromuscular blockade	Drug		group 1 group II group III

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sugammadex time following a dose of 1.5 mg / kg of sugammadex according to IBW in comparison to 2, and 4 mg / kg,		2 hrs

Secondary Outcomes

Measure	Description	Time Frame
extubation time		2 hrs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

morbidly obese patients of both sex (BMI > 40 kg.m-2)
scheduled for elective laparoscopic bariatric surgery (gastric bypass or sleeve surgery) under general anesthesia using rocuronium for tracheal intubation and maintenance of NMB
aged between 18 and 60 years and classified as ASA II - III

Exclusion Criteria:

liver and renal dysfunction,
disabling neuropsychiatric disorders,
history of stroke, brain trauma in the last 12 months
hypersensitivity to anesthetics, history of myocardial infarction, congestive heart failure
difficult tracheal intubation, and known or suspected disorder affecting NMB.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed H Othman, MD	ASSUIT UNVERSITY	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
South Egypt Cancer Instuite		Asyut		171516	Egypt