Status:
RECRUITING
High Dose Dexamethasone to Reduce Postoperative Pain After Video-Assisted Thoracoscopic Surgery Lobectomy /Segmentectomy
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Analgetic
Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The aim is to conduct a randomized controlled trial (RCT) with a high dose arm (1mg/kg) vs a low dose (8mg in total) of steroid (Dexamethasone) given intravenous (IV) after the induction of anesthesia...
Detailed Description
Annually, approximately 400 anatomical resections (lobectomy and segmentectomy) are performed using video-assisted thoracoscopic surgery (VATS) at the Department of Cardiothoracic Surgery, Rigshospita...
Eligibility Criteria
Inclusion
- Age ≥ 18 year
- Able to understand written and spoken Danish language
- PCS ≥20
- Signed written informed consent form.
- Patient planned to elective VATS lobectomy/segmentectomy
Exclusion
- Patients undergoing systemic glucocorticoid or other immunosuppressive therapies, ex-cluding inhaled steroids.
- Individuals with diabetes requiring insulin treatment.
- Pregnant or breastfeeding patients.
- Patients with known allergies to the study drug.
- Individuals with mental disabilities that may impair their capacity to provide informed consent or compromise the validity of data collection.
- Patients with diagnosed schizophrenia, active psychosis, bipolar disorder, or a history of ongoing treatment with antipsychotic and/or antidepressant medications.
- Individuals with altered pain perception due to other conditions or injuries, such as spi-nal cord or brain injuries, severe polyneuropathies, or neurological disorders.
- Regular users of opioid medications.
- Patients requiring reoperation within the first two postoperative days.
- Individuals undergoing conversion to a surgical procedure other than VATS lobecto-my/segmentectomy.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07213375
Start Date
September 1 2025
End Date
November 1 2026
Last Update
January 7 2026
Active Locations (1)
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1
Department for Cardiothoracic Surgery, Rigshospitalet
Copenhagen, Copenhagen, Denmark, 2100