NCT07385274

Brief 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, 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
Last Updated

February 4, 2026

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

January 27, 2026

Last Update Submit

January 27, 2026

Conditions

Keywords

Corrected Flow TimePeak Systolic VelocityUltrasonography, Dopplercarotid arteries

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within the first 20 minutes after induction of general anesthesia

Secondary Outcomes (5)

  • Corrected Flow Time Measured by Carotid Doppler Ultrasonography

    Pre-induction assessment

  • Delta Peak Systolic Velocity Measured by Carotid Doppler Ultrasonography

    Pre-induction assessment

  • Carotid Flow Volume Measured by Doppler Ultrasonography

    Pre-induction assessment

  • Acceleration Index Measured by Carotid Doppler Ultrasonography

    Pre-induction assessment

  • Acceleration Time Measured by Carotid Doppler Ultrasonography

    Pre-induction assessment

Study Arms (1)

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.

Other: pre- induction carotid doppler ultrasonography

Interventions

patients undergo non-invasive carotid doppler ultrasonography

Gynecologic Oncology Surgery Cohort

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

Study Officials

  • EMINE MUGE GOKSOY, MD

    Ankara Bilkent City Hospital, University of Health Sciences, Ankara, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 4, 2026

Study Start

March 1, 2025

Primary Completion

September 25, 2025

Study Completion

September 30, 2025

Last Updated

February 4, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

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

Locations