Spinal AnesthesiaNCT06236217
Prediction of Spinal Anesthesia-Induced Hypotension in Cesarian Section: Carotid Artery-Corrected Flow Time Versus Cardiometry
A study testing Carotid Ultrasound and Electrical cardiometry in people with Spinal Anesthesia and Hypotension, run by Tanta University at 1 site in Egypt.
Trial summary
This research aimed to evaluate and compare the role of carotid corrected flow time (FTc) and electrical cardiometry (EC) in the prediction and prevention of post-spinal hypotension in elective cesarian section. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Spinal Anesthesia, Hypotension, Cesarian Section
- What is being tested?
- Carotid Ultrasound and Electrical cardiometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 1 Jul 2023
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years.
- American Society of Anesthesiologists (ASA) physical status II.
- Gestational age (GA) ≥ 36 weeks.
- Women planned elective cesarean section under spinal anesthesia.
Who cannot join
- Patient refusal to participate in the study.
- Gestational age of < 36 or ≥40 weeks of pregnancy.
- Pregnancy-induced hypertension.
- Diabetes.
- Cardiovascular diseases, arrhythmia.
- Antepartum hemorrhage.
- Body Mass Index (BMI) above 36 kg/m2.
- Clinical fetal complications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Spinal Anesthesia-Induced Hypotension in Cesarian Section: Carotid Artery-Corrected Flow Time Versus Cardiometry: Randomized Controlled Trial
This research aimed to evaluate and compare the role of carotid corrected flow time (FTc) and electrical cardiometry (EC) in the prediction and prevention of post-spinal hypotension in elective cesarian section.
Read the detailed description
Spinal anesthesia is the procedure of choice for elective cesarean section (CS) because it avoids the most common side effects related to general anesthesia, such as the risk of aspiration, airway problems and the negative effects of intravenous anesthetic drugs on the fetus.
Accurate prediction of post-spinal hypotension could enhance clinical decision-making, optimize management, and facilitate early intervention. More than thirty predictors were used in the prediction of post-spinal hypotension including demographic data, hemodynamic variables, postural stress testing, peripheral perfusion indices, volume and fluid responsiveness indices, and genetic polymorphism.
The baseline parameters obtained via the bioreactance-based system may serve as a predictor of post-spinal anesthesia hypotension in parturient.
- Conditions
- Spinal Anesthesia, Hypotension, Cesarian Section, Carotid Artery, Corrected Flow Time, Cardiometry
- Being tested
- Carotid Ultrasound, Electrical cardiometry
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid UltrasoundOther
The carotid artery corrected flow time (FTc) was used in patients to optimize the volume status before performing spinal anesthesia.
Electrical cardiometryOther
Stroke volume variation (SVV) measured by electrical cardiometry (EC) was used to optimize the volume status before performing spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients received standard of care with no intervention before spinal anesthesia. |
| Carotid Ultrasound group | Experimental | The carotid artery corrected flow time (FTc) was used in patients to optimize the volume status before performing spinal anesthesia. Receives: Other: Carotid Ultrasound |
| Electrical cardiometry group | Experimental | Stroke volume variation (SVV) measured by electrical cardiometry (EC) was used to optimize the volume status before performing spinal anesthesia. Receives: Other: Electrical cardiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of post-spinal hypotension
Incidence of spinal anesthesia-induced hypotension was measured. Post spinal hypotension is defined as a drop in the SBP to less than 80mmHg, or less than 75% of the pre-anesthetic value. Hypotension was treated by IV vasopressor boluses (Ephedrine 5 mg).
Measured: Intraoperatively
Secondary outcomes (5)
The amount of intravenous fluids
The amount of intravenous fluids was assessed.
Measured: Intraoperatively
The amount of vasopressor
The amount of vasopressor was assessed. Post spinal hypotension is defined as a drop in the SBP to less than 80mmHg, or less than 75% of the pre-anesthetic value. Hypotension was treated by IV vasopressor boluses (Ephedrine 5 mg).
Measured: Intraoperatively
Umbilical cord PH
Umbilical cord PH was measured with fetal delivery.
Measured: Immediately after fetal delivery
Neonatal APGAR score
Neonatal APGAR score is a score between 7-10 is normal; a score between 4-6 needs proper reevaluation as the infant does require monitoring for 5 minutes. It was measured at 1, 5 minutes.
Measured: 5 minutes after fetal delivery
Complications
Complications such as bradycardia, pruritis and urine retention were measured
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Aug 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mahmoud Shehab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236217
- Sponsor's protocol ID
- 34801/07/21
- Status last verified
- Jan 2024
- First submitted
- 24 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Spinal Anesthesia-Induced Hypotension in Cesarian Section: Carotid Artery-Corrected Flow Time Versus Cardiometry: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06236217
- Acronym / sponsor ID
- 34801/07/21
- Conditions
- Spinal Anesthesia, Hypotension, Cesarian Section, Carotid Artery, Corrected Flow Time, Cardiometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 1 Feb 2024 (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 research aimed to evaluate and compare the role of carotid corrected flow time (FTc) and electrical cardiometry (EC) in the prediction and prevention of post-spinal hypotension in elective cesarian section.
Detailed description
Spinal anesthesia is the procedure of choice for elective cesarean section (CS) because it avoids the most common side effects related to general anesthesia, such as the risk of aspiration, airway problems and the negative effects of intravenous anesthetic drugs on the fetus.
Accurate prediction of post-spinal hypotension could enhance clinical decision-making, optimize management, and facilitate early intervention. More than thirty predictors were used in the prediction of post-spinal hypotension including demographic data, hemodynamic variables, postural stress testing, peripheral perfusion indices, volume and fluid responsiveness indices, and genetic polymorphism.
The baseline parameters obtained via the bioreactance-based system may serve as a predictor of post-spinal anesthesia hypotension in parturient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients received standard of care with no intervention before spinal anesthesia. |
| Carotid Ultrasound group | Experimental | Other: Carotid UltrasoundThe carotid artery corrected flow time (FTc) was used in patients to optimize the volume status before performing spinal anesthesia. |
| Electrical cardiometry group | Experimental | Other: Electrical cardiometryStroke volume variation (SVV) measured by electrical cardiometry (EC) was used to optimize the volume status before performing spinal anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged ≥ 18 years.
- American Society of Anesthesiologists (ASA) physical status II.
- Gestational age (GA) ≥ 36 weeks.
- Women planned elective cesarean section under spinal anesthesia.
Key exclusion criteria (8 listed)
- Patient refusal to participate in the study.
- Gestational age of < 36 or ≥40 weeks of pregnancy.
- Pregnancy-induced hypertension.
- Diabetes.
- Cardiovascular diseases, arrhythmia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid UltrasoundThe carotid artery corrected flow time (FTc) was used in patients to optimize the volume status before performing spinal anesthesia. | Other | Carotid Ultrasound group |
| Electrical cardiometryStroke volume variation (SVV) measured by electrical cardiometry (EC) was used to optimize the volume status before performing spinal anesthesia. | Other | Electrical cardiometry group |
Primary outcome
The incidence of post-spinal hypotension
Time frame: Intraoperatively
Incidence of spinal anesthesia-induced hypotension was measured. Post spinal hypotension is defined as a drop in the SBP to less than 80mmHg, or less than 75% of the pre-anesthetic value. Hypotension was treated by IV vasopressor boluses (Ephedrine 5 mg).
5 secondary outcomes
The amount of intravenous fluids
Time frame: Intraoperatively
The amount of vasopressor
Time frame: Intraoperatively
Umbilical cord PH
Time frame: Immediately after fetal delivery
Neonatal APGAR score
Time frame: 5 minutes after fetal delivery
Complications
Time frame: Intraoperatively
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 1 Feb 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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. 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?
A study testing Carotid Ultrasound and Electrical cardiometry in people with Spinal Anesthesia and Hypotension, run by Tanta 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 8 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 1 Feb 2024. 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?
The incidence of post-spinal hypotension (time frame: Intraoperatively). 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 1 Feb 2024.