The Ability of the Change in Positional Perfusion Index in Predicting Post-spinal Anesthesia Hypotension in Caesarian Section

NCT05269407 | Completed DMC

• 1 other identifier: N120
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

Our study aims to investigate the value of postural perfusion index changes as a non-invasive method to predict hypotension following spinal anesthesia for elective cesarean delivery.

Conditions

Obstetric Anesthesia Problems

Outcome Measures

Primary Outcomes (1)

• Sensitivity of positional index in predicting post-spinal hypotension

  The sensitivity of perfusion index postural change in predicting post-spinal anesthesia hypotension in caesarian section. surgeries.

  30 minutes post spinal anesthesia

Secondary Outcomes (3)

• The sensitivity of sitting perfusion index to predict post-spinal anesthesia hypotension in caesarian section.

  30 minutes post spinal anesthesia

• The sensitivity of supine perfusion index to predict post-spinal anesthesia hypotension in caesarian section.

  30 minutes post spinal anesthesia

• The correlation between perfusion index postural change and the degree of severity of hypotension in caesarian section post spina anesthesia.

  30 minutes post spinal anesthesia

Interventions

Peripheral perfusion index DEVICE

The study aimed to generate a model relating pre-spinal perfusion index to the likelihood and severity of the reduction in blood pressure in the first 20 min after spinal injection. A correlation between the delta PI and the delta SBP (the difference between the baseline maternal systolic blood pressure and the lowest blood pressure)will be investigated to establish a predictive model to define cut-off values at which perfusion index variation indicated a low risk (no or mild hypotension groups) or a high risk (moderate, severe groups) of reduction in blood pressure.. The incremental change of a measure PI, the ΔPI will be calculated as the absolute change in PI between supine and sitting positions, ΔPI=PIsupine-sitting. The relative change in PI the rPI, will be expressed as the percentage of change in PI, rPI=ΔPI/PIsitting× 100.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

A total of 115 consecutive adult female patients, aged \>18 years scheduled for the elective caesarian section under spinal anesthesia will be included in the study.

You may qualify if:

• ASA physical status 1-2 Age \> 18 years uncomplicated singleton pregnancy at full-term Elective scheduled caesarian section under spinal anesthesia

You may not qualify if:

• pre-existing hypertension gestational hypertension or preeclampsia Diabetes mellitus, or autonomic neuropathy Patients with peripheral vascular diseases known fetal abnormality. Emergency caesarian section. Placenta previa or placenta accrete. absolute contraindications or failure to perform spinal anesthesia.Study

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine

Cairo, 11562, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: March 8, 2022
• Study Start: March 20, 2022
• Primary Completion: March 18, 2023
• Study Completion: March 19, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

EG (1)