Perfusion Index as a Predictor of Hypotension Following Sub-arachnoid Block Among Patients Undergoing Lower Segment Caesarean Section

NCT ID: NCT06426784

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-27

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypotension Hypotension on Induction Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Low Perfusion index

Pregnant patients having baseline perfusion index less than 3.5 will be enrolled into this group.

No interventions assigned to this group

High Perfusion index

Pregnant patients having baseline perfusion index ≥ 3.5 will be enrolled into this group.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pakistan Institute of Medical Sciences

OTHER_GOV

Sponsor Role collaborator

Muhammad Haroon Anwar

OTHER_GOV

Sponsor Role lead

Responsible Party

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Muhammad Haroon Anwar

Principal Investigator, Department of Anaesthesia and Critical Care Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Muhammad Haroon Anwar, MBBS

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia and Critical Care, Pakistan Institute of Medical Sciences, Islamabad

Locations

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Deparment of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences

Islamabad, Federal, Pakistan

Site Status

Countries

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Pakistan

References

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Lal J, Bansal T, Bhardwaj S, Jain M, Singh AK. A study to evaluate perfusion index as a predictor of hypotension following spinal anesthesia for caesarean section. J Anaesthesiol Clin Pharmacol. 2022 Apr-Jun;38(2):294-299. doi: 10.4103/joacp.JOACP_385_20. Epub 2022 Jun 16.

Reference Type RESULT
PMID: 36171921 (View on PubMed)

Other Identifiers

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F-5-2/2024(ERRB)/PIMS

Identifier Type: -

Identifier Source: org_study_id

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