Clinical trial NCT03319433: Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia in Lower Segment Caesarean Section
Official title: Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia in Lower Segment Caesarean Section
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal
Hypotension
Perfusion Index
Keywords: spinal hypotension
perfusion index
caesarean section
Lead sponsor: Paropakar Maternity and Women's Hospital
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 130
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Parturient presenting to Paropakar Maternity and Women's Hospital for elective caesarean section.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of hypotension
timeFrame: 3 months
Secondary outcomes:
measure: Perfusion index
timeFrame: 3 months
measure: Side-effects
timeFrame: 3 months
measure: Systolic blood pressure
timeFrame: 3 months
measure: Diastolic blood pressure
timeFrame: 3 months
measure: Mean arterial pressure
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
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.
citation: 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.
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.
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.