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Clinical Trials/CTRI/2024/04/065859
CTRI/2024/04/065859
Not yet recruiting
Not Applicable

Perfusion index as predictor of hypotension following spinal anaesthesia in patients undergoing caesarean section for use of prophylactic phenylephrine.

Divya1 site in 1 country100 target enrollmentStarted: April 25, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Divya
Enrollment
100
Locations
1
Primary Endpoint
Perfusion index, SpO2 and heart rate

Overview

Brief Summary

This study is being conducted to assess and confirm the usefulness of perfusion index as a

predictor of spinal hypotension in parturients undergoing lower segment caesarean section.

Furthermore, by measuring PI preoperatively (value > 3.5) we can define patients at risk of

developing post spinal hypotension and guide the use of prophylactic phenylephrine infusion

in such patients. We also aim to study a control group in which perfusion index shall be used

to determine the need of bolus rescue doses of phenylephrine and this can simultaneously

determine the usefulness of either treatment methodology.

Study Design

Study Type
Interventional
Allocation
Na
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • ASA GRADE 2 ,3 pregnant female undergoing lscs elective and emergency surgery.

Exclusion Criteria

  • ASA grade 4 and above pregnant female undergoing lscs and with haemoglobin less than 4.

Outcomes

Primary Outcomes

Perfusion index, SpO2 and heart rate

Time Frame: Perfusion index, SpO2 and heart rate will be measured every 1 min and bp every 3 minutes till delivery of placenta .

the sensory level shall be assessed and thereafter the incidence of hypotension, need for vasopressors and the number of episodes of bradycardia will be recorded.

Time Frame: Perfusion index, SpO2 and heart rate will be measured every 1 min and bp every 3 minutes till delivery of placenta .

Secondary Outcomes

  • APGAR score of the baby(at 0 and 1 minute)

Investigators

Sponsor
Divya
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Divya

Sgt medical college and research institute

Study Sites (1)

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