NCT07488182

Brief Summary

This prospective observational study aims to evaluate the predictive value of preoperative carotid Doppler ultrasound parameters, including carotid velocity-time integral (carotid VTI) and corrected carotid flow time (ccFT), for post-induction hypotension in adult patients undergoing elective non-cardiac surgery under general anesthesia. Hemodynamic instability during anesthesia induction is a common and clinically important problem associated with adverse perioperative outcomes. Carotid Doppler ultrasonography provides a rapid and non-invasive method for assessing hemodynamic status at the bedside. In this study, carotid Doppler measurements will be performed in the preoperative period and their association with post-induction hypotension will be analyzed. The results of this study may help identify patients at risk for hypotension and improve perioperative hemodynamic management.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

March 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 17, 2026

Last Update Submit

March 17, 2026

Conditions

Keywords

Doppler UltrasoundVelocity Time IntegralAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Post-induction hypotension

    Occurrence of post-induction hypotension after anesthesia induction, defined as either a decrease in mean arterial pressure (MAP) of ≥30% from baseline or a MAP \<65 mmHg sustained for at least 1 minute.

    From anesthesia induction until 10 minutes after tracheal intubation or until the start of surgery, whichever occurs first.

Secondary Outcomes (1)

  • Predictive performance of carotid Doppler parameters

    From the initiation of anesthetic induction until 10 minutes after tracheal intubation or until surgical incision, whichever occurs first.

Study Arms (1)

Elective Non-Cardiac Surgery Patients

Patients undergoing elective non-cardiac surgery will be prospectively enrolled. Preoperative carotid Doppler ultrasonography parameters, including carotid velocity time integral (VTI) and corrected carotid flow time (ccFT), will be measured before anesthesia induction. No intervention will be applied as part of the study protocol. Patients will be followed for the occurrence of post-induction hypotension after standardized anesthesia induction.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled for elective non-cardiac surgery under general anesthesia will be included in this study.

You may qualify if:

  • Adult patients aged 18-65 years
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Scheduled for elective non-cardiac surgery under general anesthesia
  • Planned endotracheal intubation
  • Ability to provide written informed consent

You may not qualify if:

  • Refusal to participate in the study
  • Planned emergency surgery
  • Planned cardiac surgery
  • Presence of carotid artery stenosis greater than 50%
  • Moderate to severe valvular heart disease
  • Presence of atrial fibrillation or significant arrhythmia
  • Advanced heart failure
  • Preoperative hypotension or hemodynamic instability
  • Inability to obtain reliable ultrasonographic measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, Turkey (Türkiye)

Location

Related Publications (4)

  • Mascha EJ, Yang D, Weiss S, Sessler DI. Intraoperative Mean Arterial Pressure Variability and 30-day Mortality in Patients Having Noncardiac Surgery. Anesthesiology. 2015 Jul;123(1):79-91. doi: 10.1097/ALN.0000000000000686.

    PMID: 25929547BACKGROUND
  • Blanco P

    BACKGROUND
  • Cheong I, Otero Castro V, Sosa FA, Tort Oribe B, Fruchtenicht MF, Tamagnone FM, Merlo PM. Passive leg raising test using the carotid flow velocity-time integral to predict fluid responsiveness. J Ultrasound. 2024 Mar;27(1):97-104. doi: 10.1007/s40477-023-00824-1. Epub 2023 Sep 5.

    PMID: 37668901BACKGROUND
  • Cheong I, Otero Castro V, Sosa FA, Tort Oribe B, Merlo PM, Tamagnone FM. Carotid flow as a surrogate of the left ventricular stroke volume. J Clin Monit Comput. 2023 Apr;37(2):661-667. doi: 10.1007/s10877-022-00938-7. Epub 2022 Nov 18.

    PMID: 36399216BACKGROUND

Central Study Contacts

Engin Kılınç, Medical Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.MD

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 23, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations