Resolution of Neuro-muscular Block in Great Obese Patient... | NCT02401841

Studies
Resolution of Neuro-muscular Block in Great Obese Patients: Neostigmine vs Sugammadex

NCT02401841

Sponsor

Policlinico Hospital

Status

Unknown status

Last Update Posted

Oct 20, 2015Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Resolution of Neuromuscular Blockade

Interventions

Two different types of drug for resolution of neuro-muscular blockade

Countries

Italy

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

Oct 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Mar 2015Actual

Completion Date

Not provided

First Submitted Date

Mar 18, 2015

First Submission Date that Met QC Criteria

Mar 24, 2015

First Posted Date

Mar 30, 2015Estimated

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

Oct 19, 2015

Last Update Posted Date

Oct 20, 2015Estimated

Description Module

Brief Summary

It is a observational prospective study. The aim of this study is to compare neostigmine vs sugammadex in the resolution of neuro-muscular blockade in great obese patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sugammadex		Patients treated with Sugammadex	Drug: Two different types of drug for resolution of neuro-muscular blockade
Neostigmine		Patients treated with Neostigmine	Drug: Two different types of drug for resolution of neuro-muscular blockade

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Two different types of drug for resolution of neuro-muscular blockade	Drug		Neostigmine Sugammadex

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Differences in neuro-muscular block resolution time between two groups		up to 36 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Great obese
Videolaparoscopic surgery

Exclusion Criteria:

Age under 18
No acceptation of informed consent
New York Heart Association > 2

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Great obese patients undergoing videolaparoscopic surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Davide Chiumello, MD	Contact			chiumello@libero.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione IRCC Ca' Granda - Ospedale Maggiore Policlinico	Recruiting	Milan		20122	Italy