Erasme Randomized Controlled Trial Surveys Hemodynamic Excursions During Esophagectomy

ConditionsEsophagectomy Epidural; Anesthesia Paravertebral Anesthesia Hemodynamic Instability

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorErasme University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult, Capable of giving consent, two or three incisions esophagectomy (thoracoscopic/ thoracotomy) no laparotomy

Disqualifiers

patient refusal, total language barrier, coagulation disorders, thrombocytopenia <75 000, contraindications to locoregional anesthesia (infection local site, allergy to local anesthesic), scoliosis Cobb > 45%, atrial fibrillation, end stage renal disease),

Trial design

Design model

Parallel

Treatments tested in this trial

Hemodynamic changes between epidural and paravertebral during esophagectomy
Other intervention
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.

Treatment groups

75 Participants

are divided into 2 treatment groups

Group A: Epidural groupActive comparator 1 intervention

Group B: Paravertebral groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Consumption of norepinephrine and fluids during procedure

norepinephrine mcg/kg/hr

Time frame

6 hours

Secondary outcomes

Postoperative complications

Medical complications: Pneumonia, atrial fibrillation, thromboembolic event Surgical complications : Wound dehiscence, anastomotic leakage, chylothorax, recurrent laryngeal nerve injury

Time frame

6 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erasme University Hospital

Lead sponsor

Source ClinicalTrials.gov

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