Post-induction Hypotension (PIH)CDUS-PIHNCT07385274
Carotid Doppler Parameters and Post-Induction Hypotension
An observational study of Post-induction Hypotension (PIH) and Gynecologic Oncology Patient, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-induction Hypotension (PIH), Gynecologic Oncology Patient, Ultrasonography, Doppler
- What is being tested?
- pre- induction carotid doppler ultrasonography
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 30 Sep 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- pre- induction carotid doppler ultrasonography
- Keywords
- Corrected Flow Time, Peak Systolic Velocity, Ultrasonography, Doppler, carotid arteries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre- induction carotid doppler ultrasonographyOther
patients undergo non-invasive carotid doppler ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: pre- induction carotid doppler ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Post-Induction Hypotension
Post-induction hypotension defined as a mean arterial pressure <65 mmHg within the early post-induction period following induction of general anesthesia.
Measured: Within the first 20 minutes after induction of general anesthesia
Secondary outcomes (5)
Corrected Flow Time Measured by Carotid Doppler Ultrasonography
Corrected flow time measured by pre-induction carotid Doppler ultrasonography and its association with post-induction hypotension.
Measured: Pre-induction assessment
Delta Peak Systolic Velocity Measured by Carotid Doppler Ultrasonography
Delta Peak systolic velocity measured by pre-induction carotid Doppler ultrasonography and its association with post-induction hypotension.
Measured: Pre-induction assessment
Carotid Flow Volume Measured by Doppler Ultrasonography
Carotid flow volume obtained from pre-induction Doppler ultrasonography and its relationship with the development of post-induction hypotension.
Measured: Pre-induction assessment
Acceleration Index Measured by Carotid Doppler Ultrasonography
Acceleration index derived from pre-induction carotid Doppler ultrasonography and its association with post-induction hypotension.
Measured: Pre-induction assessment
Acceleration Time Measured by Carotid Doppler Ultrasonography
Acceleration time measured by pre-induction carotid Doppler ultrasonography and its association with post-induction hypotension.
Measured: Pre-induction assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Mar 2025
- Primary completion25 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-induction Hypotension (PIH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMINE MUGE GOKSOY, MD, Principal investigator, Ankara Bilkent City Hospital, University of Health Sciences, Ankara, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385274
- Sponsor's protocol ID
- 1-25-1378
- Acronym
- CDUS-PIH
- Status last verified
- Dec 2025
- First submitted
- 27 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to local ethical restrictions and institutional policies regarding data privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Carotid Doppler Ultrasonography Parameters for Predicting Post-Induction Hypotension in Patients Undergoing Gynecologic Oncology Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07385274
- Acronym / sponsor ID
- CDUS-PIH / 1-25-1378
- Keywords
- Corrected Flow Time, Peak Systolic Velocity, Ultrasonography, Doppler, carotid arteries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gynecologic Oncology Surgery Cohort | – | Other: pre- induction carotid doppler ultrasonographyProspective 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre- induction carotid doppler ultrasonographypatients undergo non-invasive carotid doppler ultrasonography | Other | Gynecologic Oncology Surgery Cohort |
Primary outcome
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.
5 secondary outcomes
Corrected Flow Time Measured by Carotid Doppler Ultrasonography
Time frame: Pre-induction assessment
Delta Peak Systolic Velocity Measured by Carotid Doppler Ultrasonography
Time frame: Pre-induction assessment
Carotid Flow Volume Measured by Doppler Ultrasonography
Time frame: Pre-induction assessment
Acceleration Index Measured by Carotid Doppler Ultrasonography
Time frame: Pre-induction assessment
Acceleration Time Measured by Carotid Doppler Ultrasonography
Time frame: Pre-induction assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to local ethical restrictions and institutional policies regarding data privacy and confidentiality.
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Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EMINE MUGE GOKSOY, MD principal investigator
Ankara Bilkent City Hospital, University of Health Sciences, Ankara, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-induction Hypotension (PIH) and Gynecologic Oncology Patient, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Post-Induction Hypotension (time frame: Within the first 20 minutes after induction of general anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.