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

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ClinicalTrials.gov Identifier: NCT03956186
Recruitment Status : Completed
First Posted : May 20, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
MAHMUT ARSLAN, 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. 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.

Condition or disease
Cesarean Section Complications Hypotension Spinal Anesthesia Perfusion Index Pleth Variability Index

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can we Predict Predict Spinal Anesthesia Induced Hypotension During Caesarean Section Using Right Toe Perfusion Index or Pleth Variability Index?
Actual Study Start Date : May 21, 2019
Actual Primary Completion Date : July 11, 2019
Actual Study Completion Date : July 11, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. pleth variability index (PVI) [ Time Frame: perioperative ]
    PVI values (%)at supine and lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.

  2. Perfusion index (PI) [ Time Frame: perioperative ]
    PI values(%)at supine and lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.


Secondary Outcome Measures :
  1. blood pressure (mmHg) [ Time Frame: perioperative ]
    blood pressure will be recorded



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Parturients scheduled for elective low segment caesarean section under spinal anesthesia
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956186


Locations
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Turkey
Kahramanmaras Sutcu Imam University
Kahramanmaras, In The USA Or Canada, Please Select..., Turkey, 46100
Sponsors and Collaborators
Kahramanmaras Sutcu Imam University
Investigators
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Study Director: MAHMUT ARSLAN KSU school of medicine

Additional Information:
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Responsible Party: MAHMUT ARSLAN, Assistant Professor, Kahramanmaras Sutcu Imam University
ClinicalTrials.gov Identifier: NCT03956186     History of Changes
Other Study ID Numbers: KSU 2019-07
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs