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Completed

NCT Number: NCT07385274

Carotid Doppler Parameters and Post-Induction Hypotension

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pre- induction carotid doppler ultrasonography

Other

patients undergo non-invasive carotid doppler ultrasonography

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Acronym: CDUS-PIH

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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