Hypotension on InductionNCT07370103
Carotid Artery Corrected Flow Time and Respiratory Variation of Blood Flow Peak Velocity for Prediction of Hypotension After Induction of General Anaesthesia in Adult Patients With Chronic Liver Disease
An observational study of Hypotension on Induction, run by Ain Shams University at 1 site in Egypt.
Trial summary
Baseline Measurements For the ultrasound parameters, it is the average of three readings In supine position . The investigators will continuously monitoring during induction and 10 minutes after. Hemodynamic Monitoring: Heart rate from ECG SpO2 Etco2 Blood pressure . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypotension on Induction
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2026to 30 Apr 2026
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Adult patients (≥ 18 years) with a confirmed diagnosis of CLD (e.g., cirrhosis, non-alcoholic steatohepatitis) * scheduled for elective surgery under general anesthesia. * ASA 2,3,4 * ASA 4 patients will be included only if their baseline MAP is >65 mmHg, as per the exclusion criteria
Who may be able to join
- • Adult patients (≥ 18 years) with a confirmed diagnosis of CLD (e.g., cirrhosis, non-alcoholic steatohepatitis)
- scheduled for elective surgery under general anesthesia.
- ASA 2,3,4
- ASA 4 patients will be included only if their baseline MAP is >65 mmHg, as per the exclusion criteria
Who cannot join
- • Refusal to participate
- Patients with known cardiac disease (e.g., severe valvular disease, congestive heart failure),
- pre-existing severe hypotension (e.g., mean arterial pressure <65 mmHg
- emergency surgery
- anatomical variations preventing adequate ultrasound visualization of the carotid artery.
- Carotid artery stenosis.
Show all 12Show fewer
- Mean arterial pressure (MAP) > 120 mmHg before anesthesia
- any previous record of neck surgery or trauma.
- acute renal injury.
- oral angiotensin receptor blockers or angiotensin-converting enzyme inhibitors (ACEI)
- lateral, prone, and lithotomy operations
- body mass index (BMI) > 30 kg/m2 or < 15 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Baseline Measurements
For the ultrasound parameters, it is the average of three readings In supine position .
Read more
The investigators will continuously monitoring during induction and 10 minutes after.
Hemodynamic Monitoring:
- Heart rate from ECG
- SpO2
- Etco2
- Blood pressure . invasive Blood pressure
- The radial artery level is the site of continuous arterial pressure monitoring with an arterial catheter.
- Ultrasound Measurements:
The patient will be positioned in a supine position, with the right side of the neck completely exposed. The transverse part Of the main carotid artery beneath the thyroid cartilage will be precisely identified using ultrasound device (sonosite edge portablp.fojy usa)via a linear array probe (4-15 MHz), with the marker directed toward the patient's head. Thus, the sampling line will be positioned at the center of the carotid lumen, around 2 cm from the carotid bifurcation, and the electronic angle correction cursor will be pointed in the direction of blood flow. Insonation angles between the ultrasound beam and blood flow will be maintained at or < 60°. Next, the carotid blood flow waveform will be acquired, and the consecutive stable carotid pulse Doppler flow spectrum will be determined with an optimal level of image quality.
The Correction: To get the corrected carotid flow time (ccFT), the measured FT will be adjusted for the patient's heart rate (HR). A commonly used formula is Wodey's formula.
A single, experienced sonographer will perform all measurements, and a subset of measurements will be reviewed by a second blinded observer to assess inter-rater reliability."
Peak Velocity: Measure the peak systolic blood flow velocity at the same location.
Respiratory Variation (ΔVpeak): Calculate the difference between the maximum and minimum peak velocities during a single respiratory cycle: \Delta V_{peak} = (V_{peak(max)} - V_{peak(min)}) / ((V_{peak(max)} + V_{peak(min)})/2) \times 100\%. The patient should be asked to breathe normally during this measurement.
Flow time (FT), which is known as the time period between the systolic increase phase and dicrotic notch, was calculated and then adjusted for heart rate (HR) via equations outlined below.
Wodey's (W) equation∶ FTc(W) = FT + 1.29 ∗ (HR - 60)
Anasthesia:
Patients will have routine fasting for at least 6 to 8 h and will not allowed to drink any solution or fluid 2 to 4 h prior to surgery.
No premedication will be given A standardized induction protocol will be used. At the operating theatre, a three-lead electrocardiogram (ECG), pulse oximetry (SpO2), and noninvasive arterial pressure monitoring will be applied.
After pre-oxygenation for 5 min anesthesia induction of propofol 1_2mg , fentanyl 1 ug/kg, and 0.15 mg/kg cisatracurium . After 3 min of mask ventilation, direct laryngoscopy will be employed for tracheal intubation. . Respiratory setting of anesthesia machine (Aestiva, GE/Datex-Ohmeda) will be set as follows: volume-controlled ventilation (VCV), inspiratory-expiratory (I:E) ratio of 1:2, respiratory rate of 8-10 bpm, tidal volume of 8 mL/kg of ideal weight [45.5 + 0.91x (height in cm-152.4)], and PEEP of 5 cm H2O in 50% oxygen with air. Respiratory settings will be adjusted to maintain the PETCO2 at less than 50 mmHg. Anesthesia will be maintained with sevoflurane (1.5-2.5%) and intermittent injection of cisatracurium 0.02mg/kg as needed to keep the entropy scale between 40 and 60 and for muscle relaxation. The mean arterial pressure was kept between 60 and 80 mmHg.
Hemodynamic Data Collection: Invasive mean arterial pressure (MAP) will be continuously recorded for 5-10 minutes post-induction.
Hypotension Definition: Hypotension will be defined as a decrease in MAP by >20% from the baseline value or an absolute MAP of <65 mmHg for more than one minute.This definition is clinically relevant and widely used in the anesthesia literature.
Postinduction hypotension will be treated with 250 ml saline iv boluse repeated if successfully restore blood pressure.
If refractory to fluid we will inject intravenous ephedrine in 3 mg bolus doses and repeated when necessary.
Significant bradycardia (heart rate < 40 beats/min) will be treated with intravenous boluses of atropine (0.5 mg).
Study duration 3 months or end of recruitment of sample
- Conditions
- Hypotension on Induction
- Keywords
- carotid time,respiratory variation,hypotension,chronic liver disease
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 |
|---|---|---|
| patients presented with hypotension after induction of general anaesthesia | POST INDUCTION HYPOTENSION (PIH ) group | |
| patients not presented by hypotension after induction of general anaesthesia | NON POST INDUCTION HYPOTENSION (NON PIH GROUP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
prediction of hypotension
Prediction of hypotension after induction of anesthesia by receiver operating characteristic curves of the carotid artery FTc and ΔVpeak Logistic regression analysis Cutoff value for liver disease patients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start15 Apr 2026
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension on InductionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- 35 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Mohammed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370103
- Sponsor's protocol ID
- FMASU R331/2025
- Other IDs
- ain shams university
- Status last verified
- Oct 2026
- First submitted
- 19 Jan 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Artery Corrected Flow Time and Respiratory Variation of Blood Flow Peak Velocity for Prediction of Hypotension After Induction of General Anaesthesia in Adult Patients With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT07370103
- Acronym / sponsor ID
- FMASU R331/2025
- Conditions
- Hypotension on Induction
- Keywords
- carotid time,respiratory variation,hypotension,chronic liver disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 27 Jan 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.
Baseline Measurements
For the ultrasound parameters, it is the average of three readings In supine position .
The investigators will continuously monitoring during induction and 10 minutes after.
Hemodynamic Monitoring:
- Heart rate from ECG
- SpO2
- Etco2
- Blood pressure . invasive Blood pressure
- The radial artery level is the site of continuous arterial pressure monitoring with an arterial catheter.
- Ultrasound Measurements:
The patient will be positioned in a supine position, with the right side of the neck completely exposed. The transverse part Of the main carotid artery beneath the thyroid cartilage will be precisely identified using ultrasound device (sonosite edge portablp.fojy usa)via a linear array probe (4-15 MHz), with the marker directed toward the patient's head. Thus, the sampling line will be positioned at the center of the carotid lumen, around 2 cm from the carotid bifurcation, and the electronic angle correction cursor will be pointed in the direction of blood flow. Insonation angles between the ultrasound beam and blood flow will be maintained at or < 60°. Next, the carotid blood flow waveform will be acquired, and the consecutive stable carotid pulse Doppler flow spectrum will be determined with an optimal level of image quality.
The Correction: To get the corrected carotid flow time (ccFT), the measured FT will be adjusted for the patient's heart rate (HR). A commonly used formula is Wodey's formula.
A single, experienced sonographer will perform all measurements, and a subset of measurements will be reviewed by a second blinded observer to assess inter-rater reliability."
Peak Velocity: Measure the peak systolic blood flow velocity at the same location.
Respiratory Variation (ΔVpeak): Calculate the difference between the maximum and minimum peak velocities during a single respiratory cycle: \Delta V_{peak} = (V_{peak(max)} - V_{peak(min)}) / ((V_{peak(max)} + V_{peak(min)})/2) \times 100\%. The patient should be asked to breathe normally during this measurement.
Flow time (FT), which is known as the time period between the systolic increase phase and dicrotic notch, was calculated and then adjusted for heart rate (HR) via equations outlined below.
Wodey's (W) equation∶ FTc(W) = FT + 1.29 ∗ (HR - 60)
Anasthesia:
Patients will have routine fasting for at least 6 to 8 h and will not allowed to drink any solution or fluid 2 to 4 h prior to surgery.
No premedication will be given A standardized induction protocol will be used. At the operating theatre, a three-lead electrocardiogram (ECG), pulse oximetry (SpO2), and noninvasive arterial pressure monitoring will be applied.
After pre-oxygenation for 5 min anesthesia induction of propofol 1_2mg , fentanyl 1 ug/kg, and 0.15 mg/kg cisatracurium . After 3 min of mask ventilation, direct laryngoscopy will be employed for tracheal intubation. . Respiratory setting of anesthesia machine (Aestiva, GE/Datex-Ohmeda) will be set as follows: volume-controlled ventilation (VCV), inspiratory-expiratory (I:E) ratio of 1:2, respiratory rate of 8-10 bpm, tidal volume of 8 mL/kg of ideal weight [45.5 + 0.91x (height in cm-152.4)], and PEEP of 5 cm H2O in 50% oxygen with air. Respiratory settings will be adjusted to maintain the PETCO2 at less than 50 mmHg. Anesthesia will be maintained with sevoflurane (1.5-2.5%) and intermittent injection of cisatracurium 0.02mg/kg as needed to keep the entropy scale between 40 and 60 and for muscle relaxation. The mean arterial pressure was kept between 60 and 80 mmHg.
Hemodynamic Data Collection: Invasive mean arterial pressure (MAP) will be continuously recorded for 5-10 minutes post-induction.
Hypotension Definition: Hypotension will be defined as a decrease in MAP by >20% from the baseline value or an absolute MAP of <65 mmHg for more than one minute.This definition is clinically relevant and widely used in the anesthesia literature.
Postinduction hypotension will be treated with 250 ml saline iv boluse repeated if successfully restore blood pressure.
If refractory to fluid we will inject intravenous ephedrine in 3 mg bolus doses and repeated when necessary.
Significant bradycardia (heart rate < 40 beats/min) will be treated with intravenous boluses of atropine (0.5 mg).
Study duration 3 months or end of recruitment of sample
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients presented with hypotension after induction of general anaesthesia | – | –POST INDUCTION HYPOTENSION (PIH ) group |
| patients not presented by hypotension after induction of general anaesthesia | – | –NON POST INDUCTION HYPOTENSION (NON PIH GROUP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Adult patients (≥ 18 years) with a confirmed diagnosis of CLD (e.g., cirrhosis, non-alcoholic steatohepatitis) * scheduled for elective surgery under general anesthesia. * ASA 2,3,4 * ASA 4 patients will be included only if their baseline MAP is >65 mmHg, as per the exclusion criteria
Key inclusion criteria (4 listed)
- • Adult patients (≥ 18 years) with a confirmed diagnosis of CLD (e.g., cirrhosis, non-alcoholic steatohepatitis)
Key exclusion criteria (12 listed)
- • Refusal to participate
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
prediction of hypotension
Time frame: 3 months
Prediction of hypotension after induction of anesthesia by receiver operating characteristic curves of the carotid artery FTc and ΔVpeak Logistic regression analysis Cutoff value for liver disease patients
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 3 Nov 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypotension on Induction, run by Ain Shams University at 1 site in Egypt.
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 12 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 3 Nov 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 Egypt. 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?
prediction of hypotension (time frame: 3 months). 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 3 Nov 2026.