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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06237543
Other study ID # 2024-2
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 1, 2024
Est. completion date February 1, 2026

Study information

Verified date January 2024
Source Aydin Adnan Menderes University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 52
Est. completion date February 1, 2026
Est. primary completion date February 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Written informed consent; 2. 18-75 years old 3. ASA Physical Status 1-3; 4. Patients planned for pulmonary resection surgery Exclusion Criteria: 1. The patient is pregnant 2. After cardiac surgery 3. Severe pulmonary hypertension 4. Severe valve disease 5. Hypertrophic or dilated cardiomyopathy 6. Presence of acute myocardial infarction 7. Patients with severe visual or hearing impairment/disability 8. ASA physical status IV or V 9. Ischemic heart disease, conduction disorder. 10. History of long-term use of certain medications (ß-blockers, angiotensin converting enzyme inhibitors, analgesics, sedatives or tricyclic antidepressants)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
hypotension
MAP below 55 mmHg or long-term (2 minutes or more) hypotensive attacks will be treated with ephedrine 0.1mg/kg.

Locations

Country Name City State
Turkey Ferdi Gülasti Aydin

Sponsors (1)

Lead Sponsor Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary echocardiography TAPSE/ PASP (mm/mmHg) 30 minute
Secondary tension Intraoperative systolic arterial tension, diastolic arterial tension and mean arterial tension will be taken and recorded for the patients. 4-5 hours
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