MedTrace Logo

Hemodynamic Impact of Epidural Anesthesia in Relation to Age in Pediatric Patients.

NCT05543824 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2022-09-21

No results posted yet for this study

Summary

Epidural analgesia is established as the gold standard in the management of post-surgical pain in multiple modalities, including the pediatric patient. It is a technique that is not without risks, but with multiple benefits such as less response to stress, less incidence of chronic pain after surgery, less incidence of nausea and vomiting and other adverse effects derived from opioids, faster recovery and increased patient and family satisfaction.

However, as it has been mentioned, the epidural carries risks both in the technique itself (wet or intravascular puncture) and subsequently after the injection of medication that generates a sympathetic blockade with arterial hypotension and an increase in compensatory heart rate. Unlike in adult patients, in pediatric patients epidural and subarachnoid anesthesia are better tolerated hemodynamically due to less vagal and sympathetic activity and almost no systemic venodilation. This lower activity of the autonomic nervous system is due to its immaturity, which is why, with the growth of the infant, this anesthetic technique increasingly affects its hemodynamics, being similar to the adult at the age of 8-12 years.

The study hypothesis does not differ from that stated in physiology books and studies, but the investigators seek to identify the direct correlation of age with the different hemodynamic parameters available with current technology (cardiac output, systemic vascular resistance, blood pressure ) in pediatric patients after epidural anesthesia.

The study will be carried out in pediatric patients undergoing major surgery that requires the placement of an epidural catheter and invasive blood pressure, without modifying in any way the usual practice of the responsible anesthesiologist. The patient's hemodynamic data will be collected at time 0 (prior to catheter placement), one minute, 5 and 10 minutes after the bolus of local anesthetic administered to measure the child's hemodynamic response and relate it to their age and development. .

Conditions

  • Hemodynamic Monitoring
  • Anesthesia; Adverse Effect
  • Pediatric Major Surgery
  • Epidural Analgesia

Interventions

DRUG

Levobupivacaine

Patients who require placement of an epidural catheter to control postoperative pain and invasive blood pressure will be identified, allowing advanced monitoring using the MostCare Up® device. After identification, the objective of the study will be explained and their consent will be requested to collect the data after the intervention, recording the hemodynamic data before and after the initial bolus of local anesthetic administered: 0.25% levobupivacaine, the dose of which is calculated with the Takasaki formula: 0.05ml x weight (kg) x number of dermatomes to anesthetize

Sponsors & Collaborators

  • Hospital Universitario La Fe

    lead OTHER

Eligibility

Min Age
0 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-12
Primary Completion
2023-04-18
Completion
2023-09-10
FDA Drug
Yes

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05543824 on ClinicalTrials.gov