Carotid Doppler Parameters and Post-Induction Hypotension (CDUS-PIH)

January 27, 2026 updated by: Ankara City Hospital Bilkent

Evaluation of Carotid Doppler Ultrasonography Parameters for Predicting Post-Induction Hypotension in Patients Undergoing Gynecologic Oncology Surgery: A Prospective Observational Study

Post-induction hypotension is a common complication following the induction of general anesthesia and is associated with adverse postoperative outcomes. Patients undergoing gynecologic oncology surgery represent a particularly vulnerable population due to advanced age, high comorbidity burden, and increased frailty, which may predispose them to perioperative hemodynamic instability.

This prospective observational study aims to evaluate whether carotid Doppler ultrasonography parameters, including corrected flow time and other flow-related indices, can predict the occurrence of post-induction hypotension specifically in patients undergoing gynecologic oncology surgery.

Adult patients scheduled for elective gynecologic oncology surgery under general anesthesia will undergo pre-induction carotid Doppler ultrasonography as part of routine perioperative assessment. Baseline clinical characteristics, including the Charlson Comorbidity Index and Clinical Frailty Scale, will be recorded for each participant. Hemodynamic parameters will be recorded following anesthetic induction, and the development of post-induction hypotension will be assessed.

The findings of this study may help identify high-risk patients within the gynecologic oncology population and support the use of non-invasive carotid Doppler measurements, comorbidity burden, and frailty assessment for perioperative risk stratification in this specific surgical group.

Study Overview

Detailed Description

Post-induction hypotension (PIH) frequently occurs after the induction of general anesthesia and has been associated with increased perioperative morbidity, including myocardial injury, acute kidney injury, and prolonged hospital stay. Patients undergoing gynecologic oncology surgery constitute a high-risk population due to malignancy-related physiological changes, advanced age, multiple comorbidities, and increased frailty. Despite this elevated risk, data focusing specifically on predictors of PIH in the gynecologic oncology population remain limited.

Carotid Doppler ultrasonography provides real-time information about cardiac output surrogates and preload responsiveness through parameters such as corrected flow time and peak systolic velocity. These measurements may offer a practical, non-invasive method for assessing hemodynamic reserve before anesthetic induction, particularly in high-risk oncologic surgical populations.

This prospective observational study includes adult patients undergoing elective gynecologic oncology surgery under general anesthesia. Pre-induction carotid Doppler ultrasonography will be performed to obtain flow-related parameters. Baseline patient characteristics will be documented, with particular emphasis on comorbidity burden assessed using the Charlson Comorbidity Index and functional vulnerability evaluated using the Clinical Frailty Scale.

Standard anesthetic induction will be conducted according to routine clinical practice. Blood pressure measurements will be recorded before and after induction, and post-induction hypotension will be defined according to predefined criteria.

The primary objective of the study is to evaluate the association between carotid Doppler ultrasonography parameters and the development of post-induction hypotension in the gynecologic oncology population. Secondary objectives include assessment of the relationships between comorbidity burden, frailty status, Doppler-derived indices, and perioperative hemodynamic outcomes within this specific patient group.

The results of this study may contribute to improved perioperative risk assessment and support the integration of carotid Doppler ultrasonography, comorbidity indices, and frailty evaluation into routine anesthetic practice for patients undergoing gynecologic oncology surgery.

Study Type

Observational

Enrollment (Actual)

91

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult female patients aged 18 years or older undergoing elective gynecologic oncology surgery under general anesthesia. All participants are evaluated prospectively in a single-center setting. Pre-induction carotid Doppler ultrasonography is performed as part of the perioperative assessment. Baseline comorbidity burden and frailty status are assessed using the Charlson Comorbidity Index and Clinical Frailty Scale. Patients meeting predefined inclusion and exclusion criteria are enrolled consecutively.

Description

Inclusion Criteria:

  • Female patients aged 18 years or older
  • Scheduled for elective gynecologic oncology surgery under general anesthesia
  • Planned standard anesthetic induction
  • Ability to provide written informed consent

Exclusion Criteria:

  • Refusal to participate in the study
  • Inability to obtain informed consent, including patients with dementia
  • Emergency surgery
  • American Society of Anesthesiologists (ASA) physical status IV or higher
  • Cardiac rhythm other than sinus rhythm
  • Autonomic nervous system disorders
  • Atrial fibrillation with rapid ventricular response
  • Pregnancy
  • Sepsis or septic shock
  • Significant valvular heart disease or peripheral vascular disease
  • Anticipated difficult ventilation and/or difficult intubation
  • Left ventricular ejection fraction <40%
  • Severe aortic valve stenosis
  • Morbid obesity (body mass index >40 kg/m²)
  • Presence of implanted cardiac pacemaker or implantable cardioverter-defibrillator
  • Chronic beta-blocker therapy
  • Baseline mean arterial pressure <65 mmHg at admission
  • Baseline systolic arterial blood pressure >190 mmHg or diastolic arterial blood pressure >110 mmHg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gynecologic Oncology Surgery Cohort
Prospective observational single-center cohort of adult patients undergoing elective gynecologic oncology surgery under general anesthesia. Pre-induction carotid Doppler ultrasonography parameters were recorded to evaluate the prediction of post-induction hypotension. Baseline comorbidity burden and frailty status were assessed using the Charlson Comorbidity Index and Clinical Frailty Scale. No study-specific interventions were performed.
patients undergo non-invasive carotid doppler ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Post-Induction Hypotension
Time Frame: Within the first 20 minutes after induction of general anesthesia
Post-induction hypotension defined as a mean arterial pressure <65 mmHg within the early post-induction period following induction of general anesthesia.
Within the first 20 minutes after induction of general anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corrected Flow Time Measured by Carotid Doppler Ultrasonography
Time Frame: Pre-induction assessment
Corrected flow time measured by pre-induction carotid Doppler ultrasonography and its association with post-induction hypotension.
Pre-induction assessment
Delta Peak Systolic Velocity Measured by Carotid Doppler Ultrasonography
Time Frame: Pre-induction assessment
Delta Peak systolic velocity measured by pre-induction carotid Doppler ultrasonography and its association with post-induction hypotension.
Pre-induction assessment
Carotid Flow Volume Measured by Doppler Ultrasonography
Time Frame: Pre-induction assessment
Carotid flow volume obtained from pre-induction Doppler ultrasonography and its relationship with the development of post-induction hypotension.
Pre-induction assessment
Acceleration Index Measured by Carotid Doppler Ultrasonography
Time Frame: Pre-induction assessment
Acceleration index derived from pre-induction carotid Doppler ultrasonography and its association with post-induction hypotension.
Pre-induction assessment
Acceleration Time Measured by Carotid Doppler Ultrasonography
Time Frame: Pre-induction assessment
Acceleration time measured by pre-induction carotid Doppler ultrasonography and its association with post-induction hypotension.
Pre-induction assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: EMINE MUGE GOKSOY, MD, Ankara Bilkent City Hospital, University of Health Sciences, Ankara, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Actual)

September 25, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to local ethical restrictions and institutional policies regarding data privacy and confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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