Can Right Toe Perfusion Index or Pleth Variability Index Predict Spinal Anesthesia Induced Hypotension?

NCT03956186 | Completed

• 1 other identifier: KSU 2019-07
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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. There are several studies investigating the predictive value of finger PI and PVI on hypotension after spinal anesthesia. However the aortocaval compression by the gravid uterus directly effects the lower extremity perfusion. So, in this study we aimed to investigate whether the right toe PI and PVI values at supine and left lateral positions can predict hypotension during caesarean section.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• pleth variability index (PVI)

  PVI values (%)at supine and lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.

  perioperative

• Perfusion index (PI)

  PI values(%)at supine and lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.

  perioperative

Secondary Outcomes (1)

• blood pressure (mmHg)

  perioperative

Study Arms (2)

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.

Non-hypotension 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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Parturients scheduled for elective low segment caesarean section under spinal anesthesia

You may qualify if:

• singleton parturient
• planned for elective LSCS under spinal anesthesia

You may not qualify if:

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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, In the USA Or Canada, Please Select..., 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• MAHMUT ARSLAN

  KSU school of medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 20, 2019
• Study Start: May 21, 2019
• Primary Completion: July 11, 2019
• Study Completion: July 11, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)