- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07385274
Carotid Doppler Parameters and Post-Induction Hypotension (CDUS-PIH)
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
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey (Türkiye)
- Ankara Bilkent City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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patients undergo non-invasive carotid doppler ultrasonography
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Occurrence of Post-Induction Hypotension
Time Frame: Within the first 20 minutes after induction of general anesthesia
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Post-induction hypotension defined as a mean arterial pressure <65 mmHg within the early post-induction period following induction of general anesthesia.
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Within the first 20 minutes after induction of general anesthesia
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Corrected Flow Time Measured by Carotid Doppler Ultrasonography
Time Frame: Pre-induction assessment
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Corrected flow time measured by pre-induction carotid Doppler ultrasonography and its association with post-induction hypotension.
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Pre-induction assessment
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Delta Peak Systolic Velocity Measured by Carotid Doppler Ultrasonography
Time Frame: Pre-induction assessment
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Delta Peak systolic velocity measured by pre-induction carotid Doppler ultrasonography and its association with post-induction hypotension.
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Pre-induction assessment
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Carotid Flow Volume Measured by Doppler Ultrasonography
Time Frame: Pre-induction assessment
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Carotid flow volume obtained from pre-induction Doppler ultrasonography and its relationship with the development of post-induction hypotension.
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Pre-induction assessment
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Acceleration Index Measured by Carotid Doppler Ultrasonography
Time Frame: Pre-induction assessment
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Acceleration index derived from pre-induction carotid Doppler ultrasonography and its association with post-induction hypotension.
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Pre-induction assessment
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Acceleration Time Measured by Carotid Doppler Ultrasonography
Time Frame: Pre-induction assessment
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Acceleration time measured by pre-induction carotid Doppler ultrasonography and its association with post-induction hypotension.
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Pre-induction assessment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: EMINE MUGE GOKSOY, MD, Ankara Bilkent City Hospital, University of Health Sciences, Ankara, Turkey
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1-25-1378
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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