Comparison of Extubation Time Between Total Intravenous A... | NCT03360955

Studies
Comparison of Extubation Time Between Total Intravenous Anesthesia With Spinal Anesthesia for Cardiac Surgery

NCT03360955

Sponsor

Coordinación de Investigación en Salud, Mexico

Status

Unknown status

Last Update Posted

Aug 6, 2020Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Anesthesia

Interventions

Anesthesia

Countries

Mexico

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

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 13, 2017Actual

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Nov 13, 2017

First Submission Date that Met QC Criteria

Dec 1, 2017

First Posted Date

Dec 4, 2017Actual

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

Aug 5, 2020

Last Update Posted Date

Aug 6, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

This study compares the extubation time between total intravenous anesthesia guided by Bispectral Index with spinal anesthesia with minimal opioid dose for cardiac surgery.

Detailed Description

This study compares the time needed to extubate of two anesthesic techniques, 1) Total Intravenous Anesthesia guided by Bispectral Index (BIS), 2) Spinal Anesthesia with minimal opioid dose for cardiac surgery.

Identify the best anesthesia technique to do ultrafast track extubation can minimize the risk of infection associated.

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Total Intravenous Anesthesia		Patients with total intravenous anesthesia during the cardiac surgery	Procedure: Anesthesia
Spinal Anesthesia		Patients with spinal anesthesia with minimal opioid dose.	Procedure: Anesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anesthesia	Procedure	Different anesthesia technique will be compared to find out which one offers better outcome to perform ultrafast track extubation	Spinal Anesthesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Extubation time	The time from anesthesia emergence to extubation will be measured in minutes	Up to 1 hour after anesthesia emergence

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled for cardiac surgery Physical Status Classification System of the American Society of Anesthesiologists (ASA) II-III

Exclusion Criteria:

Physical Status Classification System of the American Society of Anesthesiologists (ASA) IV-V Emergency cardiac surgery Spinal defect

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients scheduled for cardiac surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ana Gabriela Gallardo, PhD	IMSS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de cardiología		Mexico City	Mexico City	06720	Mexico

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000758	Anesthesia

Ancestor Terms

ID	Term
D000760	Anesthesia and Analgesia

Browse Leaves

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Browse Branches

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