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NCT Number: NCT06563557

Erasme Randomized Controlled Trial Surveys Hemodynamic Excursions During Esophagectomy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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),

Treatment and study plan

Hemodynamic changes between epidural and paravertebral during esophagectomy

Other

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.

Primary outcomes

  1. Consumption of norepinephrine and fluids during procedure

    Time frame: 6 hours

    norepinephrine mcg/kg/hr

Secondary outcomes

  1. Postoperative complications

    Time frame: 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Annalinda CIORRA, MD

CONTACT

[email protected]

+32(0)25553324

Fanny BERNARD, MD

CONTACT

[email protected]

+32(0)25553324

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

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

Acronym: ERASME ULB

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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