| May 16, 2019
|
| May 20, 2019
|
| July 24, 2019
|
| May 21, 2019
|
| July 11, 2019 (Final data collection date for primary outcome measure)
|
- 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.
- 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.
|
|
Same as current
|
|
|
| blood pressure (mmHg) [ Time Frame: perioperative ] blood pressure will be recorded
|
|
Same as current
|
| Not Provided
|
| Not Provided
|
| |
| Can Right Toe Perfusion Index or Pleth Variability Index Predict Spinal Anesthesia Induced Hypotension?
|
| Can we Predict Predict Spinal Anesthesia Induced Hypotension During Caesarean Section Using Right Toe Perfusion Index or Pleth Variability Index?
|
| 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.
|
| Not Provided
|
| Observational
|
Observational Model: Cohort Time Perspective: Prospective
|
| Not Provided
|
| Not Provided
|
| Probability Sample
|
| Parturients scheduled for elective low segment caesarean section under spinal anesthesia
|
- Cesarean Section Complications
- Hypotension
- Spinal Anesthesia
- Perfusion Index
- Pleth Variability Index
|
| Not Provided
|
- 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.
|
| Not Provided
|
| |
| Completed
|
| 60
|
|
Same as current
|
| July 11, 2019
|
| July 11, 2019 (Final data collection date for primary outcome measure)
|
|
Inclusion Criteria:
- singleton parturient
- planned for elective LSCS under spinal anesthesia
Exclusion Criteria:
|
| Sexes Eligible for Study: |
All |
|
| 18 Years to 45 Years (Adult)
|
| No
|
|
Contact information is only displayed when the study is recruiting subjects
|
| Turkey
|
|
|
| |
| NCT03956186
|
| KSU 2019-07
|
| No
|
| Studies a U.S. FDA-regulated Drug Product: |
No |
| Studies a U.S. FDA-regulated Device Product: |
No |
|
|
|
| MAHMUT ARSLAN, Kahramanmaras Sutcu Imam University
|
| Kahramanmaras Sutcu Imam University
|
| Not Provided
|
| Study Director: |
MAHMUT ARSLAN |
KSU school of medicine |
|
| Kahramanmaras Sutcu Imam University
|
| July 2019
|