Post-induction HypotensionNCT04886089
Pleth Variability Index as a Predictor for Post-induction Hypotension in Elderly Patients
An observational study of Post-induction Hypotension, run by Cairo University at 1 site in Egypt.
Trial summary
Hypotension after induction of general anesthesia and before surgical stimulation is a prevalent anesthesia-related side effect. The post-induction hypotension disrupts organ perfusion and may cause organ damage particularly acute kidney injury, cerebrovascular stroke, and myocardial ischemia. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Post-induction Hypotension
- What is being tested?
- Pleth variability index for prediction of post-induction hypotension
- Type of treatment
- Medical device
- How many people
- 85 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 1 Jan 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Study population: all patients. Patients ≥ 65 years, ASA physical status I or II, and scheduled for elective surgery under general anesthesia will be enrolled in the study.
Who may be able to join
- patients with ASA physical status I or II
- patients will receive general anesthesia
Who cannot join
- Patients with a history of cardiorespiratory disorders
- patients with uncontrolled hypertension or cardiac dysrhythmias
- Patients with renal or hepatic diseases.
- Patients with long-standing diabetes and peripheral vascular diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-anesthesia Pleth Variability Index as a Predictor for Post-induction Hypotension in Elderly Patients Undergoing General Anesthesia: A Prospective Cohort Study
Hypotension after induction of general anesthesia and before surgical stimulation is a prevalent anesthesia-related side effect. The post-induction hypotension disrupts organ perfusion and may cause organ damage particularly acute kidney injury, cerebrovascular stroke, and myocardial ischemia. Post-induction hypotension occurs with greater frequency and severity in the elderly. This is because of aged-related diminished cardiac reserve and impaired autonomic homeostasis. Pleth variability index (PVI) is a software program that measures the dynamic changes of the PI that occurs during a complete respiratory cycle. Our primary outcome is to determine the predictive ability and the optimal cut-off value of pre-anesthesia PVI for predicting elderly patients who are at risk of developing post-induction hypotension
- Conditions
- Post-induction Hypotension
- Being tested
- Pleth variability index for prediction of post-induction hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleth variability index for prediction of post-induction hypotensionDevice
The use of the baseline Pleth variability index values for prediction of occurrence of post-induction hypotension
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy (Area under receiver operating characteristic curves) of pre-induction PVI for prediction of post-induction hypotension
Measured: before induction of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Aug 2021
- Primary completion1 Aug 2023
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-induction 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Ahmed, MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886089
- Sponsor's protocol ID
- N-126-2020
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2021
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ollaek MA, Ahmed AM, Mohamed MH, Abdelhamid BM, Sewilam MR, Ismaeil SA. Pre-anesthesia pleth variability index and perfusion index for predicting post-induction hypotension in elderly surgical patients: a cohort study. J Anesth. 2026 May 24. doi: 10.1007/s00540-026-03778-w. Online ahead of print.
PubMed 42177681
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-anesthesia Pleth Variability Index as a Predictor for Post-induction Hypotension in Elderly Patients Undergoing General Anesthesia: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04886089
- Acronym / sponsor ID
- N-126-2020
- Conditions
- Post-induction Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 13 May 2021 (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.
Hypotension after induction of general anesthesia and before surgical stimulation is a prevalent anesthesia-related side effect. The post-induction hypotension disrupts organ perfusion and may cause organ damage particularly acute kidney injury, cerebrovascular stroke, and myocardial ischemia. Post-induction hypotension occurs with greater frequency and severity in the elderly. This is because of aged-related diminished cardiac reserve and impaired autonomic homeostasis. Pleth variability index (PVI) is a software program that measures the dynamic changes of the PI that occurs during a complete respiratory cycle. Our primary outcome is to determine the predictive ability and the optimal cut-off value of pre-anesthesia PVI for predicting elderly patients who are at risk of developing post-induction hypotension
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- all patients. Patients ≥ 65 years, ASA physical status I or II, and scheduled for elective surgery under general anesthesia will be enrolled in the study.
Key inclusion criteria (2 listed)
- patients with ASA physical status I or II
- patients will receive general anesthesia
Key exclusion criteria (4 listed)
- Patients with a history of cardiorespiratory disorders
- patients with uncontrolled hypertension or cardiac dysrhythmias
- Patients with renal or hepatic diseases.
- Patients with long-standing diabetes and peripheral vascular diseases.
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 |
|---|---|---|
| Pleth variability index for prediction of post-induction hypotensionThe use of the baseline Pleth variability index values for prediction of occurrence of post-induction hypotension | Device | – |
Primary outcome
The accuracy (Area under receiver operating characteristic curves) of pre-induction PVI for prediction of post-induction hypotension
Time frame: before induction of general 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 8 Apr 2025.
- Derived from this study: PubMed 42177681Ollaek MA, Ahmed AM, Mohamed MH, Abdelhamid BM, Sewilam MR, Ismaeil SA. Pre-anesthesia pleth variability index and perfusion index for predicting post-induction hypotension in elderly surgical patients: a cohort study. J Anesth. 2026 May 24. doi: 10.1007/s00540-026-03778-w. Online ahead of print.
- Individual participant dataSharing planned: Undecided
Related trials for Post-induction Hypotension
RecruitingObservational study
The Relationship Between Hypotension and Tissue O2 in Invasive Eadyn During Anesthesia Induction in Open Heart Surgery
Post-induction Hypotension, Eadyn
Not yet recruiting
Frequency of Electrical Acupoint Stimulation on Hypotension During Induction
Anesthesia, Post-induction Hypotension (PIH)
Not yet recruitingObservational study
SV and IVC Collapsibility Index to Predict Postinduction Hypotension
Post-induction Hypotension, Intestinal Obstruction
RecruitingObservational study
Preoperative Neutrophil-to-Albumin Ratio and Post-Induction Hemodynamic Vulnerability in Major Oncologic Surgery
Hemodynamic Instability, Post-induction Hypotension (PIH)
RecruitingObservational study
Evaluation of the Relation Between Patient Fasting Time and the Occurrence of PIH (Post Induction Hypotension)
Post-induction Hypotension
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-induction 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 2 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: finished, as of the sponsor's last update on 8 Apr 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?
The accuracy (Area under receiver operating characteristic curves) of pre-induction PVI for prediction of post-induction hypotension (time frame: before induction of general anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04886089, which also lists 1 linked publication.
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 8 Apr 2025; AzTrials last refreshed its copy on 28 Oct 2026.