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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03319433
Enrollment
130
Registered
2017-10-24
Start date
2018-05-01
Completion date
2018-11-15
Last updated
2018-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension, Perfusion Index, Spinal

Keywords

spinal hypotension, perfusion index, 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.

Interventions

DEVICEPerfusion Index

Use of non-invasive pulse oximeter to determine perfusion index

Sponsors

Paropakar Maternity and Women's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of hypotension3 monthscompare the incidence of hypotension following SAB for LSCS in parturient with or without a high perfusion index.

Secondary

MeasureTime frameDescription
Perfusion index3 monthsTo compare the perfusion index (PI) at various intervals between the two groups
Side-effects3 monthsTo study the profile of side effects between the two groups.
Systolic blood pressure3 monthsTo compare the systolic blood pressure (SBP) at various intervals between the two groups.
Diastolic blood pressure3 monthsTo compare the diastolic blood pressure (DBP) at various intervals between the two groups.
Mean arterial pressure3 monthsTo compare the mean arterial pressure (MAP) at various intervals between the two groups

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026