- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06426784
Perfusion Index as a Predictor of Hypotension Following Sub-arachnoid Block Among Patients Undergoing Lower Segment Caesarean Section
May 27, 2025 updated by: Muhammad Haroon Anwar
C-section is one of the commonly performed surgical procedures.
During this surgical procedure the surgeon cuts into uterine cavity through abdominal wall and takes out the baby.
This is done by by making the lower half body of the patient numb by injecting local anesthesia drugs into the space surrounding the spinal cord.
This allows the mother to remain awake and immediately bond with the baby once it gets delivered.
Also this technique provides effective pain relief both during and after the surgery.
However like any other technique or drug it is associated with a number of side effects.
The most important being fall in blood pressure.
There are numerous ways to treat it.
However if one is able to predict fall in blood pressure before administration of anesthetic technique one can easily prevent it.
One of the recently discovered novel way to predict fall in blood pressure is Perfusion index which is calculated by Pulse oximeter.
It is a device use to check amount of oxygen in blood and heart rate.
Perfusion index refers to the total amount of blood present in the limbs of the person.
Once we administer drug in the space surrounding the spinal cord the amount of blood in the limbs increases while the amount returning to heart decreases which ultimately results in less amount of blood being pumped out by heart resulting in fall in blood pressure.
Therefore theoretically those individuals who have a high baseline Perfusion index will more likely to develop low blood pressure.
This study aims to identify the cut off value of perfusion index to predict fall in blood pressure.
Study Overview
Status
Completed
Detailed Description
Spinal anesthesia is employed to provide excellent surgical conditions in case of C-Section.
It is the anesthetic technique of choice among obstetric patients.
However it is associated with sympathectomy which reduces the venous return and ultimately causes hypotension.
This hypotension is mainly due to redistribution of blood volume to the peripheral compartment.
Perfusion index which is measured by Pulse Oximetery is a ratio of pulsatile to non-pulsatile blood in the peripheral compartment of the body.
As spinal anesthesia causes sympathectomy, peripheral blood volume increases.
As a result perfusion index value should rise.
This will then co-relate with hypotension.
In simple terms those individuals who have a high baseline Perfusion index value will more likely to develop hypotension.
This study aims to identify the baseline perfusion index value which co-relates with development of hypotension following sub-arachnoid block for C-section.
Study Type
Observational
Enrollment (Actual)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Federal
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Islamabad, Federal, Pakistan, 44000
- Deparment of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Pregnant females undergoing elective lower segment caesarean section under spinal anesthesia at Pakistan Institute of Medical sciences will be enrolled in the study.
Description
Inclusion Criteria:
- ASA class II and III
- Elective LSCS under sub-arachnoid block
- Age 18-35 years
Exclusion Criteria:
- Hypertensive disorders of pregnancy
- Autonomic neuropathy
- Fetal distress
- NPO >8h
- Lack of maintenance fluid or oral clear fluid intake during NPO period.
- BMI > 35 kg/m2
- Patients requiring Vasopressor and Ionotropic support.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Low Perfusion index
Pregnant patients having baseline perfusion index less than 3.5 will be enrolled into this group.
|
|
High Perfusion index
Pregnant patients having baseline perfusion index ≥ 3.5 will be enrolled into this group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of hypotension
Time Frame: Intra-operative peroid
|
Number of episodes of hypotension among both groups will be compared.
|
Intra-operative peroid
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Baseline perfusion index as a predictor of hypotension
Time Frame: Intra operative peroid
|
Sensitivity and specificity of baseline perfusion index to predict intra-operative hypotension following sub-arachnoid block
|
Intra operative peroid
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Muhammad Haroon Anwar, MBBS, Department of Anesthesia and Critical Care, Pakistan Institute of Medical Sciences, Islamabad
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 27, 2024
Primary Completion (Actual)
April 30, 2025
Study Completion (Actual)
April 30, 2025
Study Registration Dates
First Submitted
May 19, 2024
First Submitted That Met QC Criteria
May 19, 2024
First Posted (Actual)
May 23, 2024
Study Record Updates
Last Update Posted (Actual)
May 28, 2025
Last Update Submitted That Met QC Criteria
May 27, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F-5-2/2024(ERRB)/PIMS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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