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

NCT05543824 | Unknown FDA Drug

• 1 other identifier: REHAEPP-2022
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pediatric surgery; Epidural analgesia; Hemodynamic monitoring

Outcome Measures

Primary Outcomes (2)

• Hemodynamic repercussion

  Drop in blood pressure after epidural levobupivacaine bolus

  time zero until 10 minutes

• Age related repercussion

  Relate the blood pressure drop to the age of the patient

  0 years until 12 years

Secondary Outcomes (2)

• Epidural level

  time zero until 10 minutes

• Gender

  time zero until 10 minutes

Study Arms (1)

Epidural and arterial catheter

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.

Drug: Levobupivacaine

Interventions

Levobupivacaine DRUG

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

Also known as: epidural catheter, invasive arterial catheter

Epidural and arterial catheter

Eligibility Criteria

• Age: 0 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients under 12 years of age undergoing major surgery in the University Hospital La Fe, in Valencia

You may qualify if:

• Patients under 12 years of age undergoing major surgery with epidural catheter placement and invasive blood pressure.

You may not qualify if:

• Allergy to local anesthetics (LA).
• Congenital diseases which affect the central nervous system.
• Inability to place an invasive arterial catheter.

Sponsors & Collaborators

• Hospital Universitario La Fe: lead

Study Sites (1)

Daniel Perez Ajami

Valencia, 46026, Spain

RECRUITING

Related Publications (3)

• Gootman PM, Gootman N, Buckley BJ. Maturation of central autonomic control of the circulation. Fed Proc. 1983 Apr;42(6):1648-55.

  PMID: 6832381 BACKGROUND

• Martinez-Telleria A., Cano Serrano M.E.: Anestesia epidural lumbar. En Anestesia Locorregional en Pediatria, Blanco Vargas D., Reinoso Barbero F., Cruz Tejado J. Ed. ARAN, 2005, Madrid, Cap.9: 129-143.

  BACKGROUND

• Alonso-Inigo JM, Escriba FJ, Carrasco JI, Fas MJ, Argente P, Galvis JM, Llopis JE. Measuring cardiac output in children undergoing cardiac catheterization: comparison between the Fick method and PRAM (pressure recording analytical method). Paediatr Anaesth. 2016 Nov;26(11):1097-1105. doi: 10.1111/pan.12997. Epub 2016 Aug 27.

  PMID: 27565740 BACKGROUND

MeSH Terms

Interventions

Levobupivacaine

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 16, 2022
• Study Start: September 12, 2022
• Primary Completion: April 18, 2023
• Study Completion: September 10, 2023
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)