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

NCT ID: NCT03864692

Last Updated: 2019-06-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 88 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-22
• Study Completion Date: 2019-03-14

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Hypotension group

Parturients undergoing elective C/S under spinal anesthesia whose systolic arterial pressure drop below 80 mmHg or have symptoms of hypotension such as dizziness, nausea and vomiting during the procedure.

No interventions assigned to this group

Normotension group

Parturients undergoing elective C/S under spinal anesthesia whose systolic arterial pressure does not drop below 80 mmHg or have any symptoms of hypotension during the procedure.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role: lead

Responsible Party

MAHMUT ARSLAN

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kahramanmaras Sutcu Imam University

Kahramanmaraş, In the USA Or Canada, Please Select..., Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KSU 2018-163

Identifier Type: -

Identifier Source: org_study_id