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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03319433
• Other study ID #: ParopakarMWH
• Status: Not yet recruiting
• First received: October 19, 2017
• Last updated: April 9, 2018
• Start date: May 1, 2018
• Est. completion date: November 15, 2018

Study information

• Verified date: April 2018
• Source: Paropakar Maternity and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: November 15, 2018
• Est. primary completion date: August 30, 2018
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension
• Perfusion Index
• Spinal

Intervention

Device:
• Perfusion Index
Use of non-invasive pulse oximeter to determine perfusion index

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Paropakar Maternity and Women's Hospital

References & Publications (4)

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:CD002251. doi: 10.1002/14651858.CD002251.pub3 — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypotension	compare the incidence of hypotension following SAB for LSCS in parturient with or without a high perfusion index.	3 months
Secondary	Perfusion index	To compare the perfusion index (PI) at various intervals between the two groups	3 months
Secondary	Side-effects	To study the profile of side effects between the two groups.	3 months
Secondary	Systolic blood pressure	To compare the systolic blood pressure (SBP) at various intervals between the two groups.	3 months
Secondary	Diastolic blood pressure	To compare the diastolic blood pressure (DBP) at various intervals between the two groups.	3 months
Secondary	Mean arterial pressure	To compare the mean arterial pressure (MAP) at various intervals between the two groups	3 months