Post Spinal HypotensionNCT05587153
Perfusion Index vs Positional Hemodynamic Changes to Predict Hypotension After Spinal Anaesthesia in Caesarean Section
An observational study of Post Spinal Hypotension, run by Zagazig University at 2 sites in Egypt.
Trial summary
Comparative Study between the Perfusion Index and Positional Haemodynamic Changes for Prediction of Hypotension after Spinal Anaesthesia in Caesarean Section Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Spinal Hypotension
- What is being tested?
- perfusion index in all parturient recruited for the study
- How many people
- 80 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Jul 2022to 30 Dec 2022
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women undergoing an elective caesarean section delivery.
Who may be able to join
- Parturient acceptance.
- American Society of Anesthesiologists (ASA) II
- arturient with be gestational age >36 weeks and <41 weeks.
- Body mass index (BMI) ≤35kg/m2
- elective caesarean section delivery
Who cannot join
- preeclampsia
- eclampsia,
- gestational diabetes
- Contraindication to regional anaesthesia as allergy, coagulation abnormalities or infection in site of injection.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Faculty of medicine
Zagazig, 44519
Ramy M Husin, M.B.B. Ch, 01128601089, ramy23m@gmail.com
Naglaa Abdelhaleem, MD, 01003103036, nogaahmedkareem.fa@gmail.com
- Recruiting
Ramy
Zagazig
About this study
Official title: Comparative Study Between the Perfusion Index and Positional Haemodynamic Changes for Prediction of Hypotension After Spinal Anaesthesia in Caesarean Section
Comparative Study between the Perfusion Index and Positional Haemodynamic Changes for Prediction of Hypotension after Spinal Anaesthesia in Caesarean Section
Read the detailed description
Hypotension following spinal anaesthesia may cause maternal dizziness, nausea, vomiting and fetal acidosis, administration of prophylactic vasopressor agents in pregnant women may cause undesirable effects on the mother and fetus. Perfusion index is the ratio of a pulsatile to a non-pulsatile fraction of blood volume. The increase of the pulsatile fraction manifested during vasodilatation corresponds to a higher PI. So, the patients with a higher PI have a higher risk for post-spinal hypotension. Elevated sympathetic activity before neuraxial anaesthesia was associated with a higher risk for post-spinal hypotension. The significant variability in haemodynamic after the positional change indicates higher sympathetic activity. The high the rise in autonomic activity, the higher the risk for post-spinal hypotension
AIM OF THE WORK:
Prediction of hypotension after spinal anaesthesia in caesarean section either by perfusion index and positional haemodynamic changes
Grouping:
All the recruited patients will be assessed by perfusion index. and by positional haemodynamic changes
- Conditions
- Post Spinal Hypotension
- Being tested
- perfusion index in all parturient recruited for the study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perfusion index in all parturient recruited for the studyOther
Also called positional haemodynamic changes between supine and right lateral position in parturient .
Using perfusion index and positional hemodynamic changes for the prediction of postspinal hypotension in all parturient recruited for the study
| Study group | Role | What they receive |
|---|---|---|
| Observational study in parturient who will be recruited for the study | this study will include the eligible parturient who will be assessed by perfusion index and by positional hemodynamic changes. Receives: Other: perfusion index in all parturient recruited for the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of post-spinal hypotension using PI
To correlate between perfusion index and hypotension after spinal anaesthesia in caesarean section
Measured: 6 months
Secondary outcomes (1)
Prediction of post-spinal hypotension using positional hemodynamic changes
To correlate between positional haemodynamic changes and hypotension after spinal anaesthesia in caesarean section
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start15 Jul 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Spinal HypotensionStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Naglaa Abdelhaleem, MD, Study director, Faculty of medicine, Zagazig University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587153
- Sponsor's protocol ID
- 9293/2-2-2022
- Status last verified
- Dec 2022
- First submitted
- 8 Mar 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Perfusion Index and Positional Haemodynamic Changes for Prediction of Hypotension After Spinal Anaesthesia in Caesarean Section
- ClinicalTrials.gov ID
- NCT05587153
- Acronym / sponsor ID
- 9293/2-2-2022
- Conditions
- Post Spinal Hypotension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 19 Oct 2022 (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.
Comparative Study between the Perfusion Index and Positional Haemodynamic Changes for Prediction of Hypotension after Spinal Anaesthesia in Caesarean Section
Detailed description
Hypotension following spinal anaesthesia may cause maternal dizziness, nausea, vomiting and fetal acidosis, administration of prophylactic vasopressor agents in pregnant women may cause undesirable effects on the mother and fetus. Perfusion index is the ratio of a pulsatile to a non-pulsatile fraction of blood volume. The increase of the pulsatile fraction manifested during vasodilatation corresponds to a higher PI. So, the patients with a higher PI have a higher risk for post-spinal hypotension. Elevated sympathetic activity before neuraxial anaesthesia was associated with a higher risk for post-spinal hypotension. The significant variability in haemodynamic after the positional change indicates higher sympathetic activity. The high the rise in autonomic activity, the higher the risk for post-spinal hypotension
AIM OF THE WORK:
Prediction of hypotension after spinal anaesthesia in caesarean section either by perfusion index and positional haemodynamic changes
Grouping:
All the recruited patients will be assessed by perfusion index. and by positional haemodynamic changes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational study in parturient who will be recruited for the study | – | Other: perfusion index in all parturient recruited for the studythis study will include the eligible parturient who will be assessed by perfusion index and by positional hemodynamic changes. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women undergoing an elective caesarean section delivery.
Key inclusion criteria (5 listed)
- Parturient acceptance.
- American Society of Anesthesiologists (ASA) II
- arturient with be gestational age >36 weeks and <41 weeks.
- Body mass index (BMI) ≤35kg/m2
- elective caesarean section delivery
Key exclusion criteria (4 listed)
- preeclampsia
- eclampsia,
- gestational diabetes
- Contraindication to regional anaesthesia as allergy, coagulation abnormalities or infection in site of injection.
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 |
|---|---|---|
| perfusion index in all parturient recruited for the studyAlso: positional haemodynamic changes between supine and right lateral position in parturient .Using perfusion index and positional hemodynamic changes for the prediction of postspinal hypotension in all parturient recruited for the study | Other | Observational study in parturient who will be recruited for the study |
Primary outcome
Prediction of post-spinal hypotension using PI
Time frame: 6 months
To correlate between perfusion index and hypotension after spinal anaesthesia in caesarean section
1 secondary outcome
Prediction of post-spinal hypotension using positional hemodynamic changes
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
Naglaa Abdelhaleem, MD study director
Faculty of medicine, Zagazig University Hospitals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Spinal Hypotension, run by Zagazig University at 2 sites 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramy M Husin, M.B.B. Ch (01128601089 ext. 002, ramy23m@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of post-spinal hypotension using PI (time frame: 6 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 23 Dec 2022.