The Relationship Between Perfusion Index and Pleth Variability Index and Hemodynamics in Spinal Anesthesia

NCT05174260 | Completed

• 2 other identifiers: date:18/05/2021 ID:2021/05-23öznur uludağ
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

In routine practice, the preferred anesthesia method in cesarean section operations is spinal anesthesia, but it causes hypotension in a significant part of the patients. In this study, the researchers planned to evaluate the perfusion index (PI) and pleth variability index (PVI) values at different positions to predict hypotension after spinal anesthesia applied for cesarean section. When hypotension is severe and persistent, it may cause uteroplacental perfusion disorder, fetal hypoxia-acidosis, and neonatal neurological damage as well as nausea-vomiting, loss of consciousness, cardiac arrest and collapse in the mother(2) If hemodynamic changes such as hypotension and bradycardia are present, symptoms may occur. . Early intervention with vasoconstrictor agents will be provided to prevent the emergence of the disease, disturbing symptoms and other complications that may occur will be prevented.

Conditions

Effects of Anesthesia Spinal and Epidural in Pregnancy

Keywords

spinal anesthesia; perfusion index

Outcome Measures

Primary Outcomes (5)

• perfusion index (PI)

  Before and after spinal anesthesia, 4 measurements will be made until the baby is born, and 1 more measurement will be made after routine oxytocin. Its relationship with hemodynamic deterioration will be examined and compared between both groups.In basal values of PI and the rate of change of these values; There was no significant difference between the groups with and without hypotension.

  perioperative

• pleth variability index (PVI)

  Before and after spinal anesthesia, 4 measurements will be made until the baby is born, and 1 more measurement will be made after routine oxytocin. Its relationship with hemodynamic deterioration will be examined and compared between both groups.In basal values of PVI and the rate of change of these values; There was no significant difference between the groups with and without hypotension.

  perioperative

• BMİ-weight,

  There was no difference in BMI and weight values between patients who developed and did not develop hypotension after spinal anesthesia

  preoperratif value

• hemoglobin

  Hemoglobin (p=0.014) and hematocrit (p=0.012) values weres ignificantly lower in pregnant women who developed hypotension

  preoperatif value

• APGAR

  The 1st minute APGAR (p=0.005= and 5th minute APGAR (p=0.014) scores were significantly lower in the babies of pregnant women who developed hypotension.

  the 1st minute APGAR-the 5th minute APGAR

Secondary Outcomes (3)

• systolic blood pressure

  perioperative

• diastolic blood pressure

  perioperative

• pulse

  perioperative

Study Arms (2)

hypotension developing group

Pregnant women who underwent elective C/S under spinal anesthesia with systolic arterial pressure below 90 mmHg or with hypotension symptoms such as dizziness, nausea and vomiting during the procedure.

Device: perfusion index, pleth variable index

group without hypotension

Pregnant women who underwent elective cesarean section under spinal anesthesia whose systolic arterial pressure did not fall below 90 mmHg or did not have any symptoms of hypotension during the procedure.

Device: perfusion index, pleth variable index

Interventions

perfusion index, pleth variable index DEVICE

a clip will be attached to the patient's finger and the perfusion index and pvi will be measured

Also known as: a latch will be attached to the patient's finger

group without hypotension; hypotension developing group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Female patients aged 18-40 who will undergo elective cesarean section

You may qualify if:

• Pregnant women who will undergo elective cesarean section
• Patients with ASA 1-2
• Patients aged 18-40 years

You may not qualify if:

• Emergency cases
• \<18 or \> 40 years old
• Gestational age \<36 weeks
• BMI ≥40
• Cardiovascular disease
• Patients with ASA 3-4
• Those with peripheral vascular disease
• Patients for whom spinal anesthesia is contraindicated
• Refusal to participate

Sponsors & Collaborators

• Adiyaman University: lead

Study Sites (1)

Adıyaman University

Adıyaman, 32000, Turkey (Türkiye)

Location

Related Publications (4)

• Loubert C. Fluid and vasopressor management for Cesarean delivery under spinal anesthesia: continuing professional development. Can J Anaesth. 2012 Jun;59(6):604-19. doi: 10.1007/s12630-012-9705-9. Epub 2012 Apr 24. English, French.

  PMID: 22528166 BACKGROUND

• Langesaeter E, Rosseland LA, Stubhaug A. Continuous invasive blood pressure and cardiac output monitoring during cesarean delivery: a randomized, double-blind comparison of low-dose versus high-dose spinal anesthesia with intravenous phenylephrine or placebo infusion. Anesthesiology. 2008 Nov;109(5):856-63. doi: 10.1097/ALN.0b013e31818a401f.

  PMID: 18946298 BACKGROUND

• Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. Pleth variability index to monitor the respiratory variations in the pulse oximeter plethysmographic waveform amplitude and predict fluid responsiveness in the operating theatre. Br J Anaesth. 2008 Aug;101(2):200-6. doi: 10.1093/bja/aen133. Epub 2008 Jun 2.

  PMID: 18522935 BACKGROUND

• Tsuchiya M, Yamada T, Asada A. Pleth variability index predicts hypotension during anesthesia induction. Acta Anaesthesiol Scand. 2010 May;54(5):596-602. doi: 10.1111/j.1399-6576.2010.02225.x. Epub 2010 Mar 10.

  PMID: 20236098 RESULT

Related Links

• The Effects of Motion on the Performance of Pulse Oximeters in Volunteers (Revised publication

MeSH Terms

Interventions

Perfusion Index

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant doctor

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 30, 2021
• Study Start: December 2, 2021
• Primary Completion: January 2, 2022
• Study Completion: August 11, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-09

Locations

TU (1)