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NCT03956186
Can Right Toe Perfusion Index or Pleth Variability Index Predict Spinal Anesthesia Induced Hypotension?
trial in Cesarean Section Complications in 60 participants. Completed in 11 July 2019.
11 July 2019
Quick facts
| Lead sponsor | Kahramanmaras Sutcu Imam University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 21 May 2019 |
| Primary completion | 11 July 2019 |
| Estimated completion | 11 July 2019 |
| Sites | 1 location across Turkey (Türkiye) |
Conditions studied
- Cesarean Section Complications — all drugs for Cesarean Section Complications →
- Hypotension — all drugs for Hypotension →
- Spinal Anesthesia — all drugs for Spinal Anesthesia →
- Perfusion Index — all drugs for Perfusion Index →
Sponsor
Kahramanmaras Sutcu Imam University
Who can join
Adults 18 to 45, any sex, with Cesarean Section Complications or Hypotension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03956186 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kahramanmaras Sutcu Imam University
- Last refreshed: 24 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03956186.
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