Spinal Anesthesia Induced HypotensionNCT05259124
The Ability of Perfusion Index and Positional Perfusion Index Variation to Predict Spinal Anesthesia-induced Hypotension in Elderly Patients
An observational study of Spinal Anesthesia Induced Hypotension, run by Cairo University at 1 site in Egypt.
Trial summary
In this study, we will test the ability of positional perfusion index variation to predict post-spinal anesthesia hypotension in elderly patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Spinal Anesthesia Induced Hypotension
- What is being tested?
- positional perfusion index variation
- Type of treatment
- Medical device
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jun 2022to 23 Aug 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: A total of 68 consecutive elderly patients, aged >65 years scheduled for elective surgical operations under spinal anesthesia will be included in the study.
Who may be able to join
- 65 years of age or more.
- ASA score I \& II.
- Patients scheduled for surgeries under spinal anesthesia.
Who cannot join
- Negative consent.
- pre-existing hypertension
- Diabetes mellitus or autonomic neuropathy.
- Emergency operations.
- Absolute contraindications or failure to perform spinal anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Ability of Perfusion Index and Positional Perfusion Index Variation to Predict Spinal Anesthesia-induced Hypotension in Elderly Patients: A Prospective Observational Study
In this study, we will test the ability of positional perfusion index variation to predict post-spinal anesthesia hypotension in elderly patients.
- Conditions
- Spinal Anesthesia Induced Hypotension
- Being tested
- positional perfusion index variation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positional perfusion index variationDevice
positional perfusion index variation to predict spinal anesthesia-induced hypotension in elderly patients
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity of perfusion index postural change in predicting spinal anesthesia-induced hypotension in elderly patients.
The sensitivity of incremental change of a measured perfusion index pre and post spinal anesthesia
Measured: 30 minutes after spinal anesthesia
Secondary outcomes (3)
incidence of spinal anesthesia induced hypotension in elderly
incidence of spinal anesthesia induced hypotension in elderly
Measured: 30 minutes after spinal anesthesia
• The sensitivity of supine perfusion index to predict spinal anesthesia-induced hypotension in elderly patients.
- The sensitivity of supine perfusion index to predict spinal anesthesia-induced hypotension in elderly patients.
Measured: 30 minutes after spinal anesthesia
• The sensitivity of sitting perfusion index to predict spinal anesthesia-induced hypotension in elderly patients.
- The sensitivity of sitting perfusion index to predict spinal anesthesia-induced hypotension in elderly patients.
Measured: 30 minutes after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start3 Jun 2022
- Primary completion23 Aug 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Anesthesia Induced HypotensionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Ahmed Mahmoud AbdelKader, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259124
- Sponsor's protocol ID
- N-122-2021
- Status last verified
- Aug 2023
- First submitted
- 17 Jan 2022
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ability of Perfusion Index and Positional Perfusion Index Variation to Predict Spinal Anesthesia-induced Hypotension in Elderly Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05259124
- Acronym / sponsor ID
- N-122-2021
- Conditions
- Spinal Anesthesia Induced Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 28 Feb 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.
In this study, we will test the ability of positional perfusion index variation to predict post-spinal anesthesia hypotension in elderly patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- A total of 68 consecutive elderly patients, aged >65 years scheduled for elective surgical operations under spinal anesthesia will be included in the study.
Key inclusion criteria (3 listed)
- 65 years of age or more.
- ASA score I \& II.
- Patients scheduled for surgeries under spinal anesthesia.
Key exclusion criteria (5 listed)
- Negative consent.
- pre-existing hypertension
- Diabetes mellitus or autonomic neuropathy.
- Emergency operations.
- Absolute contraindications or failure to perform spinal anesthesia.
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 |
|---|---|---|
| positional perfusion index variationpositional perfusion index variation to predict spinal anesthesia-induced hypotension in elderly patients | Device | – |
Primary outcome
The sensitivity of perfusion index postural change in predicting spinal anesthesia-induced hypotension in elderly patients.
Time frame: 30 minutes after spinal anesthesia
The sensitivity of incremental change of a measured perfusion index pre and post spinal anesthesia
3 secondary outcomes
incidence of spinal anesthesia induced hypotension in elderly
Time frame: 30 minutes after spinal anesthesia
• The sensitivity of supine perfusion index to predict spinal anesthesia-induced hypotension in elderly patients.
Time frame: 30 minutes after spinal anesthesia
• The sensitivity of sitting perfusion index to predict spinal anesthesia-induced hypotension in elderly patients.
Time frame: 30 minutes after spinal anesthesia
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 25 Aug 2023.
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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 Spinal Anesthesia Induced Hypotension, run by Cairo 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 5 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 25 Aug 2023. 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 sensitivity of perfusion index postural change in predicting spinal anesthesia-induced hypotension in elderly patients. (time frame: 30 minutes after spinal anesthesia). 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 25 Aug 2023.