- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06237543
TAPSE/PASP Anesthesia (TAPSE/PASP)
Prediction of TAPSE/PASP Ratio for Hypotension Due to General Anesthesia Induction in Pulmonary Resection Surgery
TAPSE, one of the methods for evaluating right ventricular systolic function; It is a bar parameter that can easily measure apex-basal shortening and provides specific information about global RV function. TAPSE/PASP can be calculated as load-independent parameters to evaluate RV function. Because RV function is sensitive to change in afterload, known as the RV-pulmonary circulation (PC) connection.
This study aims to identify patients who are candidates for hypotensive events due to general anesthesia in a hemodynamically stable population.
Study Overview
Detailed Description
TAPSE, one of the methods for evaluating right ventricular systolic function; It is a bar parameter that can easily measure apex-basal shortening and provides specific information about global RV function. TAPSE/PASP can be calculated as load-independent parameters to evaluate RV function. Because RV function is sensitive to change in afterload, known as the RV-pulmonary circulation (PC) connection.
This study aims to identify patients who are candidates for hypotensive events due to general anesthesia in a hemodynamically stable population.
Patients will be measured by transthoracic echocardiography in the preoperative period, 15-30 minutes before induction.
Basal hemodynamic parameters and non-invasive and/or hemodynamic values will be recorded every two minutes after induction until surgical incision.Patients with a 30% decrease in SBP from the baseline and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered to have hypotension. Patients will be divided into 2 groups: 'with' and 'without' hypotension.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Aydın, Turkey, 09020
- Ferdi Gülaştı
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Written informed consent;
- 18-75 years old
- ASA Physical Status 1-3;
- Patients planned for pulmonary resection surgery
Exclusion Criteria:
- The patient is pregnant
- After cardiac surgery
- Severe pulmonary hypertension
- Severe valve disease
- Hypertrophic or dilated cardiomyopathy
- Presence of acute myocardial infarction
- Patients with severe visual or hearing impairment/disability
- ASA physical status IV or V
- Ischemic heart disease, conduction disorder.
- History of long-term use of certain medications (β-blockers, angiotensin converting enzyme inhibitors, analgesics, sedatives or tricyclic antidepressants)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Hypotension
Patients with a 30% decrease in SBP from baseline and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered to have hypotension.
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MAP below 55 mmHg or long-term (2 minutes or more) hypotensive attacks will be treated with ephedrine 0.1mg/kg.
Other Names:
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none hypotension
Patients who do not have a 30% decrease from the baseline in SBP and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered as not having hypotension.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
echocardiography
Time Frame: 30 minute
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TAPSE/ PASP (mm/mmHg)
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30 minute
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tension
Time Frame: 4-5 hours
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Intraoperative systolic arterial tension, diastolic arterial tension and mean arterial tension will be taken and recorded for the patients.
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4-5 hours
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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