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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Ainshams University

    Cairo

Other trials in Egypt

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

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 groups in NCT07370103
Study groupRoleWhat they receive
patients presented with hypotension after induction of general anaesthesiaPOST INDUCTION HYPOTENSION (PIH ) group
patients not presented by hypotension after induction of general anaesthesiaNON POST INDUCTION HYPOTENSION (NON PIH GROUP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted27 Jan 2026
  2. Study start15 Apr 2026
  3. Primary completion30 Apr 2026
  4. Study completion30 Apr 2026

Resources

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
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

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.

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