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

NCT03319433 | Unknown

• 1 other identifier: ParopakarMWH
• Study Type: observational
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Spinal; Hypotension; Perfusion Index

Keywords

spinal hypotension; perfusion index; caesarean section

Outcome Measures

Primary Outcomes (1)

• Incidence of hypotension

  compare the incidence of hypotension following SAB for LSCS in parturient with or without a high perfusion index.

  3 months

Secondary Outcomes (5)

• Perfusion index

  3 months

• Side-effects

  3 months

• Systolic blood pressure

  3 months

• Diastolic blood pressure

  3 months

• Mean arterial pressure

  3 months

Study Arms (2)

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

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

Interventions

Perfusion Index DEVICE

Use of non-invasive pulse oximeter to determine perfusion index

Group I (Perfusion Index <3.5); Group II (Perfusion index >3.5)

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• ASA II physical status.
• Planned for elective LSCS
• Gestational age \>36 weeks and \<41 weeks

You may not qualify if:

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

Sponsors & Collaborators

• Paropakar Maternity and Women's Hospital: lead

Related Publications (4)

• 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.

  PMID: 27213856 RESULT

• 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.

  PMID: 28976555 RESULT

• 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.

  PMID: 25610851 RESULT

• 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.

  PMID: 28890560 RESULT

MeSH Terms

Conditions

Hypotension

Interventions

Perfusion Index

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 24, 2017
• Study Start: May 1, 2018
• Primary Completion: August 30, 2018
• Study Completion: November 15, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04