NCT03360955

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

November 13, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 4, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 6, 2020

Status Verified

August 1, 2020

Enrollment Period

4.1 years

First QC Date

November 13, 2017

Last Update Submit

August 5, 2020

Conditions

Anesthesia

Keywords

ExtubationCardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • Extubation time

    The time from anesthesia emergence to extubation will be measured in minutes

    Up to 1 hour after anesthesia emergence

Study Arms (2)

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

AnesthesiaPROCEDURE

Different anesthesia technique will be compared to find out which one offers better outcome to perform ultrafast track extubation

Spinal AnesthesiaTotal Intravenous Anesthesia

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled for cardiac surgery

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de cardiología

Mexico City, Mexico City, 06720, Mexico

Location

MeSH Terms

Interventions

Anesthesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • Ana Gabriela Gallardo, PhD

    IMSS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2017

First Posted

December 4, 2017

Study Start

November 13, 2017

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

August 6, 2020

Record last verified: 2020-08

Locations

ME(1)