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

Hypotension Clinical Trial

Official title:

Prediction of Hypotension Using Perfusion Index and Pleth Variability Index After Spinal Anesthesia for Caesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03864692
• Other study ID #: KSU 2018-163
• Status: Completed
• Start date: January 22, 2019
• Est. completion date: March 14, 2019

Study information

• Verified date: June 2019
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 14, 2019
• Est. primary completion date: March 14, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Hypotension
• Perfusion Index
• Pleth Variability Index
• Spinal Anesthesia

Locations

Country	Name	City	State
Turkey	Kahramanmaras Sutcu Imam University	Kahramanmaras	In The USA Or Canada, Please Select...

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood pressure	Blood pressure (mmHg) at supine, head-up, head-down and lateral positions will be recorded and compared between the 2 groups.	perioperative
Primary	pleth variability index (PVI)	PVI values (%)at supine, head-up, head-down, lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.	perioperative
Primary	Perfusion index (PI)	PI values (%) at supine, head-up, head-down, lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.	perioperative
Secondary	heart rate	Heart rate (beat per minute) at supine, head-up, head-down and lateral positions will be recorded and compared between the 2 groups.	perioperative