Post-induction Hypotension (PIH)PLRNCT07777159
Carotid Doppler Changes After Passive Leg Raising for Prediction of Post-Induction Hypotension in Gastrointestinal Tumor Surgery
An observational study of Post-induction Hypotension (PIH) and Gastrointestinal Tumor Surgery, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-induction Hypotension (PIH), Gastrointestinal Tumor Surgery
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Refusal to participate or inability to obtain written informed consent
- BMI ≥40 kg/m²
- Pregnancy
- Emergency surgery
- Difficult intubation
- ASA physical status ≥IV
Show all 19Show fewer
- 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%)
- Severe pulmonary disease or advanced respiratory failure
- Implanted cardiac device (pacemaker/ICD)
- Baseline mean arterial pressure (MAP) <65 mmHg
- Preoperative systolic blood pressure >190 mmHg or diastolic blood pressure >110 mmHg
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, 06100
Seçilnaz Ünlü Tuncer, MD, +90 5531773618, secilnaz.unlu@gmail.com
About this study
Official title: Dynamic Changes in Carotid Artery Doppler Parameters Following Passive Leg Raising for Prediction of Post-Induction Hypotension in Patients Undergoing Elective Gastrointestinal Tumor Surgery
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.
Read the detailed description
The study will be conducted on patients scheduled for elective gastrointestinal tumor surgery. Prior to anesthesia induction, a passive leg raise maneuver will be performed. Carotid artery Doppler parameters and hemodynamic changes will be measured and recorded to evaluate their efficacy in predicting subsequent post-induction hypotension.
- Keywords
- Carotid Doppler, Passive Leg Raise, Post-induction Hypotension, Anesthesia İnduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Evaluation of the association between baseline carotid Doppler parameters (VTI, PSV, and FTc) and the development of post-induction hypotension.
Measured: 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
Determination of the optimal cut-off values of ΔVTI, ΔPSV, and ΔFTc for predicting post-induction hypotension.
Measured: 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
Evaluation of the association between ΔVTI, ΔPSV, and ΔFTc and the duration and severity of post-induction hypotension.
Measured: From general anesthesia induction to 20 minutes post-induction
Association of carotid Doppler changes with vasopressor requirement
Evaluation of the association between ΔVTI, ΔPSV, and ΔFTc and the requirement for vasopressor treatment after anesthesia induction.
Measured: From general anesthesia induction to 20 minutes post-induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seçilnaz Ünlü Tuncer, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777159
- Sponsor's protocol ID
- TABED 1-26-2663
- Acronym
- PLR
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be shared to protect patient privacy and confidentiality in accordance with institutional policies and local regulations
Publications
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.
PubMed 38025582Wang 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.
PubMed 36402973
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes in Carotid Artery Doppler Parameters Following Passive Leg Raising for Prediction of Post-Induction Hypotension in Patients Undergoing Elective Gastrointestinal Tumor Surgery
- ClinicalTrials.gov ID
- NCT07777159
- Acronym / sponsor ID
- PLR / TABED 1-26-2663
- Keywords
- Carotid Doppler, Passive Leg Raise, Post-induction Hypotension, Anesthesia İnduction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Aug 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.
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.
Detailed description
The study will be conducted on patients scheduled for elective gastrointestinal tumor surgery. Prior to anesthesia induction, a passive leg raise maneuver will be performed. Carotid artery Doppler parameters and hemodynamic changes will be measured and recorded to evaluate their efficacy in predicting subsequent post-induction hypotension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- Refusal to participate or inability to obtain written informed consent
- BMI ≥40 kg/m²
- Pregnancy
- Emergency surgery
- Difficult intubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive performance of dynamic changes in carotid Doppler parameters (ΔVTI, ΔPSV, ΔFTc) for post-induction hypotension
Time frame: From pre-induction passive leg raising assessment to 20 minutes after general anesthesia induction
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
4 secondary outcomes
Association of baseline carotid Doppler parameters with post-induction hypotension
Time frame: 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
Time frame: 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
Time frame: From general anesthesia induction to 20 minutes post-induction
Association of carotid Doppler changes with vasopressor requirement
Time frame: From general anesthesia induction to 20 minutes post-induction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 38025582Chowdhury 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.
- Background: PubMed 36402973Wang 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.
- Individual participant dataSharing planned: No. The data will not be shared to protect patient privacy and confidentiality in accordance with institutional policies and local regulations
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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.
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 Gastrointestinal Tumor Surgery, 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 5 inclusion and 19 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: opening soon, as of the sponsor's last update on 20 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seçilnaz Ünlü Tuncer, MD (+90 553 177 36 18, secilnaz.unlu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive performance of dynamic changes in carotid Doppler parameters (ΔVTI, ΔPSV, ΔFTc) for post-induction hypotension (time frame: From pre-induction passive leg raising assessment to 20 minutes after general anesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07777159, which also lists 2 linked publications.
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 20 Aug 2026.