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Erasme Randomized Controlled Trial Surveys Hemodynamic Excursions During Esophagectomy

NCT06563557 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2024-08-21

No results posted yet for this study

Summary

In our high volume center, the majority of esophagectomy procedures are performed with minimally invasive techniques. The thoracic epidural technique remains the gold standard and homolateral paravertebral catheter is strongly recommended. The vasoplegia and sympathetic blockade due to the epidural can cause significant hypotension especially as reverse Trendelenburg position is required during surgery. The aim is to study hemodynamic changes caused by two different techniques. Previous studies found a similar pain management between both locoregional techniques, however few studies suggested less side effects in the paravertebral group during major abdominal surgeries.

Conditions

  • Esophagectomy
  • Epidural; Anesthesia
  • Paravertebral Anesthesia
  • Hemodynamic Instability

Interventions

OTHER

Hemodynamic changes between epidural and paravertebral during esophagectomy

The thoracic epidural technique remains the gold standard for perioperative pain management for this procedure. The placement of a paravertebral catheter homolateral with the thoracic incisions is strongly recommended. A goal directed fluid therapy is proposed to guide fluid management and limit postoperative complications. Few studies suggested less side effects in the paravertebral group. The vasoplegia due to the epidural can cause significant hypotension especially as reverse Trendelenburg position is required during surgery. The aim is to bring more light to the hemodynamic changes caused by two different locoregional techniques. An algorithm for fluid and vasopressor management has been proposed. We defined hypotension as 20% of decrement of the median arterial pressure during anesthesia. To reduce bias, the locoregional techniques is performed by an experienced anesthesiologists and the rest of the perioperative management is conducted by another blinded anesthesiologist.

Sponsors & Collaborators

  • Erasme University Hospital

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2026-08-01
Completion
2026-12-12

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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 NCT06563557 on ClinicalTrials.gov