NCT06414811

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 10, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

July 30, 2024

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

May 10, 2024

Last Update Submit

July 29, 2024

Conditions

Keywords

TAPSEPASPGENERAL ANESTHESİA

Outcome Measures

Primary Outcomes (1)

  • 1. tension

    Intraoperative systolic arterial tension, diastolic arterial tension and mean arterial tension will be taken and recorded for the patients.

    4-5 hours]

Study Arms (2)

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.

Other: HYPOTENSİON

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.

Interventions

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

Also known as: TREATMENT
Hypotension

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ASA1-3 patients aged 18-75 who will undergo elective surgery

You may qualify if:

  • Written informed consent;
  • years old
  • ASA Physical Status 1-3;
  • Patients planned for surgery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ferdi Gülaştı

Aydin, 09020, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hypotension

Interventions

Hypotension, ControlledTherapeutics

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASS. PROF. DR

Study Record Dates

First Submitted

May 10, 2024

First Posted

May 16, 2024

Study Start

May 15, 2024

Primary Completion

January 15, 2025

Study Completion

March 15, 2025

Last Updated

July 30, 2024

Record last verified: 2024-05

Locations