Post Spinal Anaesthesia HypotensionNCT07279805
Peripheral Perfusion Index as a Predictor of Post-spinal Hypotension in Patients Undergoing Lower Limb Surgeries
An observational study of Post Spinal Anaesthesia Hypotension, run by Ain Shams University at 1 site in Egypt.
Trial summary
This prospective observational study was carried out on a sample of 40 patients over a period of 6 months to asses the peripheral perfusion index as a Predictor for post spinal hypotension in patient undergoing lower limp surgeries. Read more about this study
- Who is it for?
- Ages 21 to 40 years
- Conditions the study is for
- Post Spinal Anaesthesia Hypotension
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Sep 2024to 9 Mar 2025
- 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 21 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: All patients undergoing elective lower limb surgeries at El-demerdash Hospital of Surgery during the study period. Surgeries include Anterior/Posterior curciate ligament repair,knee arthroscopy,Hip and Knee replacement,tendon repair and varicose veins ligation.
Who may be able to join
- Adult patients aging between 21-40 years of both sexes with average weight of 60-80 kg, and average height of 160-180.
- Patients undergoing Elective Lower limb Surgeries under successful spinal anesthesia (duration of surgery 45-120 minutes).
- ASA physical status classes I - II.
Who cannot join
- Patient's refusal of procedure or participation in the study.
- ASA classes III or above. Coagulopathy and bleeding disorders.
- Body mass index >40kg/m2
- Contraindications to spinal anesthesia.
- Hypersensitivity to the study medications.
- Patients receiving vasoactive drugs.
Show all 9Show fewer
- Patients undergoing emergency surgery.
- Duration more than 2hours.
- Major bleeding.
Trial locations and contacts
1 site in 1 country.
About this study
This prospective observational study was carried out on a sample of 40 patients over a period of 6 months to asses the peripheral perfusion index as a Predictor for post spinal hypotension in patient undergoing lower limp surgeries.
- Conditions
- Post Spinal Anaesthesia Hypotension
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the ability of baseline peripheral perfusion index to predict post spinal hypotension spinal anesthesia-induced hypotension in patients undergoing lower limb surgeries
Assess the ability of baseline peripheral perfusion index to predict post spinal hypotension
Measured: during the operation time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start9 Sep 2024
- Primary completion9 Mar 2025
- Study completion9 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Spinal Anaesthesia HypotensionStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279805
- Sponsor's protocol ID
- fmasu ms579/2024
- Status last verified
- Aug 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Perfusion Index as a Predictor of Post-spinal Hypotension in Patients Undergoing Lower Limb Surgeries
- ClinicalTrials.gov ID
- NCT07279805
- Acronym / sponsor ID
- fmasu ms579/2024
- Conditions
- Post Spinal Anaesthesia Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 9 Mar 2025 (actual)
- Study completion
- 9 Mar 2025 (actual)
- First posted
- 12 Dec 2025 (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 observational study was carried out on a sample of 40 patients over a period of 6 months to asses the peripheral perfusion index as a Predictor for post spinal hypotension in patient undergoing lower limp surgeries.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients undergoing elective lower limb surgeries at El-demerdash Hospital of Surgery during the study period. Surgeries include Anterior/Posterior curciate ligament repair,knee arthroscopy,Hip and Knee replacement,tendon repair and varicose veins ligation.
Key inclusion criteria (3 listed)
- Adult patients aging between 21-40 years of both sexes with average weight of 60-80 kg, and average height of 160-180.
Key exclusion criteria (9 listed)
- Patient's refusal of procedure or participation in the study.
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
Assess the ability of baseline peripheral perfusion index to predict post spinal hypotension spinal anesthesia-induced hypotension in patients undergoing lower limb surgeries
Time frame: during the operation time.
Assess the ability of baseline peripheral perfusion index to predict post spinal hypotension
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 12 Dec 2025.
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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?
An observational study of Post Spinal Anaesthesia Hypotension, 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 3 inclusion and 9 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 12 Dec 2025. 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?
Assess the ability of baseline peripheral perfusion index to predict post spinal hypotension spinal anesthesia-induced hypotension in patients undergoing lower limb surgeries (time frame: during the operation time.). 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 12 Dec 2025.