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

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
      • Islamabad, Federal, Pakistan, 44000
        • Deparment of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences

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.

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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