Prediction of Hypotension Using Perfusion Index and Pleth Variability Index After Spinal Anesthesia for C/S

Completed

• Conditions: Hypotension; Cesarean Section Complications; Perfusion Index; Spinal Anesthesia; Pleth Variability Index

• Registration Number: NCT03864692
• Lead Sponsor: Kahramanmaras Sutcu Imam University

Brief Summary

Spinal anesthesia for caesarean section is associated with a decrease in systemic vascular resistance and cardiac output and may cause hypotension in a significant portion of the parturients. Hypotension during delivery may cause maternal and fetal complications. If parturients who are likely to develop hypotension after spinal anesthesia can be identified before surgery, anesthesiologists would have opportunity to take measures such as prophylactic vasopressor administration.

Perfusion index (PI) measured by pulse oximetry reflects vasomotor tone which affects the degree of hypotension after spinal anesthesia. This is a non-invasive method of assessing the relative vascular tone with the use of pulse oximeter which calculates the ratio of pulsatile versus the non-pulsatile component of the blood flow. A lower PI indicates greater peripheral vasomotor tone.

Pleth variability index (PVI) is calculated using maximum and minimum values of perfusion index during respiratory cycles. PVI is one of the dynamic indices that can predict fluid responsiveness.

The aim of this study is to investigate whether the PI and PVI values at different patient positions can predict hypotension during caesarean section.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-22
• Study First Submitted: 2019-02-28
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-06
• Primary Completion: 2019-03-14
• Study Completion: 2019-03-14
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-15
• Last Update Posted: 2019-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

• singleton parturient
• planned for elective LSCS under spinal anesthesia

Exclusion Criteria

• gestational age < 36 weeks
• emergency cases
• placenta previa, pre-eclampsia
• BMI>40
• Reynauld disease
• patient refusal
• cardiovascular disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perfusion index (PI)	perioperative	PI values (%) at supine, head-up, head-down, lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.
pleth variability index (PVI)	perioperative	PVI values (%)at supine, head-up, head-down, lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.

Secondary Outcome Measures

Name	Time	Method
heart rate	perioperative	Heart rate (beat per minute) at supine, head-up, head-down and lateral positions will be recorded and compared between the 2 groups.

Trial Locations

Locations (1)

Kahramanmaras Sutcu Imam University; 🇹🇷 Kahramanmaras, In The USA Or Canada, Please Select..., Turkey