NCT07121699

Brief Summary

Preoperatively, patients will undergo transthoracic echocardiography measurements approximately 15-30 minutes before induction. TTE will be performed on all patients by an experienced observer; the echocardiography device will be equipped with an S4-2 transducer (4-2 MHz frequency range) in the left lateral decubitus position. VTI and Vpeak values of the LVOT were measured from manually drawn contours using pulsatile wave Doppler technique in the apical five-chamber view. The Doppler beam was aligned with the aortic blood flow, and the signal was captured at an appropriate angle (\<20°). The maximum (VTImax) and minimum (VTImin) VTI, as well as the maximum (Vpeakmax) and minimum (Vpeakmin) Vpeak values, were determined over three respiratory cycles. ΔVTI was calculated with the following formula: ΔVTI = \[2 × (VTImax - VTImin) / (VTImax + VTImin)\] × 100%. ΔVpeak was calculated with the following formula: ΔVpeak = \[2 × (Vpeakmax - Vpeakmin) / (Vpeakmax + Vpeakmin)\] × 100%. These parameters were analyzed to evaluate the hemodynamic status of patients and estimate fluid responsiveness. Patients with a 30% decrease from baseline in SBP and a decrease in MAP below 60 mmHg in the first 10 minutes after anesthesia induction were considered to have hypotension. Patients were divided into two groups: "with" and "without" hypotension.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2025

Status
not yet 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

August 7, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

August 20, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2025

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

Same day

First QC Date

August 7, 2025

Last Update Submit

August 7, 2025

Conditions

Keywords

respiratory variability in peak velocity (Vpeak)left ventricular outflow tract (LVOT) velocity-time integral (VTI)general anesthesiahypotension

Outcome Measures

Primary Outcomes (1)

  • lvot-vtı

    The relationship between hypotension following induction of general anesthesia and respiratory variability in left ventricular outflow tract VTI peak velocity (Vpeak variability).

    1 hour

Secondary Outcomes (1)

  • lv echo

    1 hour

Study Arms (2)

with 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.

Drug: Inotrope

none 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.

Interventions

Hypotensive attacks with MAP below 55 mmHg or prolonged duration (2 minutes or more) will be treated with ephedrine 0.1 mg/kg.

with hypotension

Eligibility Criteria

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

This study will be conducted on hemodynamically stable patients aged between 18 and 75 years, with an American Society of Anesthesiologists (ASA) physical status classification of I-III, who are scheduled for elective surgery and will undergo general anesthesia.

You may qualify if:

  • years
  • ASA Physical Status 1-3;
  • Patients scheduled for general anesthesia

You may not qualify if:

  • Patient is pregnant
  • Post-cardiac surgery
  • Severe pulmonary hypertension
  • Severe valvular disease
  • Hypertrophic or dilated cardiomyopathy
  • Presence of acute myocardial infarction
  • Patients with severe visual or hearing impairment/impairment
  • ASA physical status IV or V
  • Ischemic heart disease, conduction disturbance
  • History of long-term use of certain medications (β-blockers, angiotensin-converting enzyme inhibitors, analgesics, sedatives, or tricyclic antidepressants)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
asst. prof.dr

Study Record Dates

First Submitted

August 7, 2025

First Posted

August 13, 2025

Study Start

August 20, 2025

Primary Completion

August 20, 2025

Study Completion

September 1, 2025

Last Updated

August 13, 2025

Record last verified: 2025-08