NCT06563557

Erasme Randomized Controlled Trial Surveys Hemodynamic Excursions During Esophagectomy

ERASME ULB: Erasme Randomized Controlled Trial Surveys Hemodynamic Excursions During Esophagectomy - a Double Blind Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-08-01
• Completion: 2026-12-12
• First posted: 2024-08-21
• Last updated: 2024-08-21