| Registry | NCT03319433 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 130 (Estimated) |
| Sponsor | Paropakar Maternity and Women's Hospital (Other) |
| Conditions | Spinal, Hypotension, Perfusion Index |
| Interventions | Perfusion Index (Device) |
| Dates | start 2018-05-01 (estimated), primary completion 2018-08-30 (estimated), completion 2018-11-15 (estimated), first posted 2017-10-24, last updated 2018-04-11 |
Related Papers Related Patents Related Grants Related Experts
All trials for Spinal All trials for Hypotension All trials of Perfusion Index
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group I (Perfusion Index <3.5) | Device: 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) | Device: Perfusion Index | Those parturient with perfusion index >3.5 when baseline monitors are attached while the patient is being prepared for surgery. |
Sex: Female, ages: 20 Years to 35 Years
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.