NCT07777159

Brief Summary

This prospective study aims to investigate the role of the passive leg raise maneuver prior to anesthesia induction in predicting post-induction hypotension among elective gastrointestinal tumor surgery patients using carotid artery Doppler parameters.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress37%
Sep 2026Dec 2026

First Submitted

Initial submission to the registry

August 17, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 20, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 17, 2026

Last Update Submit

August 17, 2026

Conditions

Keywords

Carotid DopplerPassive Leg RaisePost-induction HypotensionAnesthesia İnduction

Outcome Measures

Primary Outcomes (1)

  • Predictive performance of dynamic changes in carotid Doppler parameters (ΔVTI, ΔPSV, ΔFTc) for post-induction hypotension

    Evaluation of the predictive performance of percentage changes in carotid artery velocity time integral (ΔVTI), peak systolic velocity (ΔPSV), and corrected flow time (ΔFTc) after passive leg raising maneuver for post-induction hypotension

    From pre-induction passive leg raising assessment to 20 minutes after general anesthesia induction

Secondary Outcomes (4)

  • Association of baseline carotid Doppler parameters with post-induction hypotension

    From pre-induction assessment to 20 minutes after general anesthesia induction

  • Cut-off values of changes in carotid Doppler parameters for prediction of post-induction hypotension

    From pre-induction passive leg raising assessment to 20 minutes after general anesthesia induction

  • Association of carotid Doppler changes with duration and severity of hypotension

    From general anesthesia induction to 20 minutes post-induction

  • Association of carotid Doppler changes with vasopressor requirement

    From general anesthesia induction to 20 minutes post-induction

Study Arms (1)

Elective Gastrointestinal tumor surgery group

Patients scheduled for elective gastrointestinal tumor surgery under general anesthesia who undergo preoperative carotid Doppler assessment and a passive leg raising (PLR) maneuver

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 18 years or older who are scheduled for elective gastrointestinal tumor surgery under general anesthesia. Eligible participants will be ASA physical status I-III and have a BMI \<40 kg/m². Both sexes will be eligible.

You may qualify if:

  • Adults aged 18 years or older
  • Patients scheduled for elective gastrointestinal tumor surgery
  • Surgery planned under general anesthesia
  • Body mass index (BMI) \<40 kg/m²
  • Written informed consent provided

You may not qualify if:

  • Refusal to participate or inability to obtain written informed consent
  • BMI ≥40 kg/m²
  • Pregnancy
  • Emergency surgery
  • Difficult intubation
  • ASA physical status ≥IV
  • Pediatric patients (\<18 years)
  • Inability to perform carotid Doppler measurements
  • Arrhythmia other than continuous sinus rhythm or uncontrolled cardiac arrhythmia
  • Severe cardiac dysfunction or left ventricular ejection fraction \<40%
  • Severe valvular heart disease
  • Clinically significant autonomic nervous system disorders
  • Inadequate noninvasive blood pressure monitoring or inability to obtain the required hemodynamic measurements
  • Active sepsis or systemic inflammatory syndrome
  • Severe peripheral vascular disease or significant carotid artery stenosis (\>50%)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (2)

  • Chowdhury AR, Thakuria R, Maitra S, Nath S, Baidya DK, Subramanium R, Anand RK, Kayina CA. Carotid artery corrected flow time and respiratory variation of blood flow peak velocity for prediction of hypotension after induction of general anesthesia in adult patients undergoing emergency laparotomy for peritonitis: A prospective, observational study. J Anaesthesiol Clin Pharmacol. 2023 Jul-Sep;39(3):444-450. doi: 10.4103/joacp.joacp_372_21. Epub 2023 May 5.

    PMID: 38025582BACKGROUND
  • Wang J, Li Y, Su H, Zhao J, Tu F. Carotid artery corrected flow time and respiratory variations of peak blood flow velocity for prediction of hypotension after induction of general anesthesia in elderly patients. BMC Geriatr. 2022 Nov 19;22(1):882. doi: 10.1186/s12877-022-03619-x.

    PMID: 36402973BACKGROUND

Central Study Contacts

Seçilnaz Ünlü Tuncer, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 17, 2026

First Posted

August 20, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 20, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

The data will not be shared to protect patient privacy and confidentiality in accordance with institutional policies and local regulations

Locations