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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06563557
Acronym
ERASME ULB
Enrollment
75
Registered
2024-08-21
Start date
2024-08-31
Completion date
2026-12-12
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidural; Anesthesia, Esophagectomy, Hemodynamic Instability, Paravertebral Anesthesia

Brief 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.

Interventions

OTHERHemodynamic 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

Erasme University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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),

Design outcomes

Primary

MeasureTime frameDescription
Consumption of norepinephrine and fluids during procedure6 hoursnorepinephrine mcg/kg/hr

Secondary

MeasureTime frameDescription
Postoperative complications6 monthsMedical complications: Pneumonia, atrial fibrillation, thromboembolic event Surgical complications : Wound dehiscence, anastomotic leakage, chylothorax, recurrent laryngeal nerve injury

Contacts

Primary ContactAnnalinda CIORRA, MD
annalinda.ciorra@hubruxelles.be+32(0)25553324
Backup ContactFanny BERNARD, MD
fanny.bernard@hubruxelles.be+32(0)25553324

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026