AnesthesiaNCT03360955
Comparison of Extubation Time Between Total Intravenous Anesthesia With Spinal Anesthesia for Cardiac Surgery
An observational study of Anesthesia, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 13 Nov 2017to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for cardiac surgery
Who may be able to join
- Patients scheduled for cardiac surgery Physical Status Classification System of the American Society of Anesthesiologists (ASA) II-III
Who cannot join
- Physical Status Classification System of the American Society of Anesthesiologists (ASA) IV-V Emergency cardiac surgery Spinal defect
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- Anesthesia
- Keywords
- Extubation, Cardiac Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnesthesiaProcedure or surgery
Different anesthesia technique will be compared to find out which one offers better outcome to perform ultrafast track extubation
| Study group | Role | What they receive |
|---|---|---|
| Total Intravenous Anesthesia | Patients with total intravenous anesthesia during the cardiac surgery Receives: Procedure: Anesthesia | |
| Spinal Anesthesia | Patients with spinal anesthesia with minimal opioid dose. Receives: Procedure: Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation time
The time from anesthesia emergence to extubation will be measured in minutes
Measured: Up to 1 hour after anesthesia emergence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start13 Nov 2017
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ana Gabriela Gallardo, PhD, Principal investigator, IMSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360955
- Sponsor's protocol ID
- R-2017-3604-40
- Status last verified
- Aug 2020
- First submitted
- 13 Nov 2017
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Extubation Time Between Total Intravenous Anesthesia Guided by Bispectral Index With Spinal Anesthesia With Minimal Opioid Dose for Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03360955
- Acronym / sponsor ID
- R-2017-3604-40
- Conditions
- Anesthesia
- Keywords
- Extubation, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 4 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Intravenous Anesthesia | – | Procedure: AnesthesiaPatients with total intravenous anesthesia during the cardiac surgery |
| Spinal Anesthesia | – | Procedure: AnesthesiaPatients with spinal anesthesia with minimal opioid dose. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for cardiac surgery
Key inclusion criteria (1 listed)
- Patients scheduled for cardiac surgery Physical Status Classification System of the American Society of Anesthesiologists (ASA) II-III
Key exclusion criteria (1 listed)
- Physical Status Classification System of the American Society of Anesthesiologists (ASA) IV-V Emergency cardiac surgery Spinal defect
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnesthesiaDifferent anesthesia technique will be compared to find out which one offers better outcome to perform ultrafast track extubation | Procedure or surgery | Spinal Anesthesia, Total Intravenous Anesthesia |
Primary outcome
Extubation time
Time frame: Up to 1 hour after anesthesia emergence
The time from anesthesia emergence to extubation will be measured in minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Gabriela Gallardo, PhD principal investigator
IMSS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation time (time frame: Up to 1 hour after anesthesia emergence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.