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

Comparison of Extubation Time Between Total Intravenous Anesthesia Guided by Bispectral Index With Spinal Anesthesia With Minimal Opioid Dose for Cardiac Surgery

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

Study Overview

• Status: Unknown
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: Anesthesia

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Mexico
  • Cdmx
    • Ciudad de mexico, Cdmx, Mexico, 06720
      • Hospital de cardiología

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients scheduled for cardiac surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Total Intravenous Anesthesia; Patients with total intravenous anesthesia during the cardiac surgery	Procedure: Anesthesia; Different anesthesia technique will be compared to find out which one offers better outcome to perform ultrafast track extubation
Spinal Anesthesia; Patients with spinal anesthesia with minimal opioid dose.	Procedure: Anesthesia; Different anesthesia technique will be compared to find out which one offers better outcome to perform ultrafast track extubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Coordinación de Investigación en Salud, Mexico
• Investigators: Principal Investigator: Ana Gabriela Gallardo, PhD, IMSS

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2017
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 13, 2017
• First Submitted That Met QC Criteria: December 1, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Actual): August 6, 2020
• Last Update Submitted That Met QC Criteria: August 5, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Cardiac Surgery; Extubation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: R-2017-3604-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No