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

NCT06426784 | Completed DMC

• 1 other identifier: F-5-2/2024(ERRB)/PIMS
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of hypotension

  Number of episodes of hypotension among both groups will be compared.

  Intra-operative peroid

Secondary Outcomes (1)

• Baseline perfusion index as a predictor of hypotension

  Intra operative peroid

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant females undergoing elective Lower segment caesarean section
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• ASA class II and III
• Elective LSCS under sub-arachnoid block
• Age 18-35 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Muhammad Haroon Anwar: lead
• Pakistan Institute of Medical Sciences: collaborator

Study Sites (1)

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

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 36171921 RESULT

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Muhammad Haroon Anwar, MBBS

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Department of Anaesthesia and Critical Care Medicine

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: May 23, 2024
• Study Start: May 27, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)