Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia in Lower Segment Caesarean Section

Spinal anesthesia for caesarean section is invariably associated with variable degree of hypotension. Hypotension that occurs may be detrimental to various organ system due to inadequate perfusion. Various methods and agents have been tried in order to address this problem. However, this calamity is far from over.

Perfusion index is one such attempt to address the problem of hypotension by predicting which group of parturient may develop hypotension. This is a type of non-invasive method of assessing the relative vascular tone with the use of pulse oximeter which calculates the ration of pulsatile versus the non-pulsatile component of the blood flow. During normal physiological changes in pregnancy, there is relative loss of vascular tone which predisposes this group of patient to sudden development of hypotension after the sympathetic block due to spinal anesthesia.

Thus, the aim of the study is to use the non-invasive perfusion index data to predict the occurrence of hypotension in a parturient so that helps us to guide fluid and other drug therapy to address the problem of hypotension.

Study Overview

• Status: Unknown
• Conditions: Hypotension; Perfusion Index; Spinal
• Intervention / Treatment: Device: Perfusion Index

• Study Type: Observational
• Enrollment (Anticipated): 130

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Parturient presenting to Paropakar Maternity and Women's Hospital for elective caesarean section.

Description

Inclusion Criteria:

1. ASA II physical status.
2. Planned for elective LSCS
3. Gestational age >36 weeks and <41 weeks

Exclusion Criteria:

1. Patient's refusal.
2. Emergency LSCS.
3. Patient's with contraindications to spinal anesthesia
4. Patient with BMI >40, preeclampsia, placenta praevia.
5. Patients with comorbidities like cerebrovascular or cardiovascular disease, and gestational diabetes.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I (Perfusion Index <3.5); Those parturient with perfusion index <3.5 when baseline monitors are attached while the patient is being prepared for surgery.	Device: Perfusion Index; Use of non-invasive pulse oximeter to determine perfusion index
Group II (Perfusion index >3.5); Those parturient with perfusion index >3.5 when baseline monitors are attached while the patient is being prepared for surgery.	Device: Perfusion Index; Use of non-invasive pulse oximeter to determine perfusion index

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypotension	compare the incidence of hypotension following SAB for LSCS in parturient with or without a high perfusion index.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perfusion index	To compare the perfusion index (PI) at various intervals between the two groups	3 months
Side-effects	To study the profile of side effects between the two groups.	3 months
Systolic blood pressure	To compare the systolic blood pressure (SBP) at various intervals between the two groups.	3 months
Diastolic blood pressure	To compare the diastolic blood pressure (DBP) at various intervals between the two groups.	3 months
Mean arterial pressure	To compare the mean arterial pressure (MAP) at various intervals between the two groups	3 months

Collaborators and Investigators

• Sponsor: Paropakar Maternity and Women's Hospital

Publications and helpful links

General Publications

• Soma-Pillay P, Nelson-Piercy C, Tolppanen H, Mebazaa A. Physiological changes in pregnancy. Cardiovasc J Afr. 2016 Mar-Apr;27(2):89-94. doi: 10.5830/CVJA-2016-021.
• Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2017 Aug 4;8(8):CD002251. doi: 10.1002/14651858.CD002251.pub3.
• Nag DS, Samaddar DP, Chatterjee A, Kumar H, Dembla A. Vasopressors in obstetric anesthesia: A current perspective. World J Clin Cases. 2015 Jan 16;3(1):58-64. doi: 10.12998/wjcc.v3.i1.58.
• Duggappa DR, Lokesh M, Dixit A, Paul R, Raghavendra Rao RS, Prabha P. Perfusion index as a predictor of hypotension following spinal anaesthesia in lower segment caesarean section. Indian J Anaesth. 2017 Aug;61(8):649-654. doi: 10.4103/ija.IJA_429_16.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2018
• Primary Completion (ANTICIPATED): August 30, 2018
• Study Completion (ANTICIPATED): November 15, 2018

Study Registration Dates

• First Submitted: October 19, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (ACTUAL): October 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 9, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: caesarean section; perfusion index; spinal hypotension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: ParopakarMWH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No