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

• Conditions: Spinal; Hypotension; Perfusion Index
• Interventions: Device: Perfusion Index

• Registration Number: NCT03319433
• Lead Sponsor: Paropakar Maternity and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-19
• Study First Submitted QC: 2017-10-19
• Study First Posted: 2017-10-24
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-09
• Last Update Posted: 2018-04-11
• Study Start: 2018-05-01
• Primary Completion: 2018-08-30
• Study Completion: 2018-11-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 130

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group I (Perfusion Index <3.5)	Perfusion Index	Those parturient with perfusion index \<3.5 when baseline monitors are attached while the patient is being prepared for surgery.
Group II (Perfusion index >3.5)	Perfusion Index	Those parturient with perfusion index \>3.5 when baseline monitors are attached while the patient is being prepared for surgery.

Primary Outcome Measures

Name	Time	Method
Incidence of hypotension	3 months	compare the incidence of hypotension following SAB for LSCS in parturient with or without a high perfusion index.

Secondary Outcome Measures

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