Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator
Condition(s) studied
Investigational drug(s) / intervention(s)
Placebo: Intravenous administration of 0.9% saline according to the study protocol during elective primary total hip arthroplasty performed under spinal anesthesia combined with ultrasound-guided Pericapsular Nerve Group (PENG) block. The placebo solution will be identical in appearance and volume to dexmedetomidine to maintain blinding.
Dexmedetomidine: Intravenous dexmedetomidine administered according to the randomized study protocol during elective primary total hip arthroplasty performed under spinal anesthesia combined with ultrasound-guided Pericapsular Nerve Group (PENG) block. Participants will receive low-dose dexmedetomidine according to group allocation.
Dexmedetomidine: Intravenous dexmedetomidine administered according to the randomized study protocol during elective primary total hip arthroplasty performed under spinal anesthesia combined with ultrasound-guided Pericapsular Nerve Group (PENG) block. Participants will receive high-dose dexmedetomidine according to group allocation.
Study summary
Surgical trauma induces activation of the sympathetic nervous system and triggers a systemic inflammatory response that may adversely affect postoperative recovery. Dexmedetomidine, a highly selective α2-adrenoceptor agonist, has been proposed as a pharmacological neuromodulatory strategy capable of attenuating sympathetic activation and modulating neuroimmune interactions during the perioperative period. However, the extent to which intravenous dexmedetomidine influences perioperative inflammatory biomarkers and clinical recovery in patients undergoing total hip arthroplasty under regional anesthesia remains unclear.
This prospective, randomized, double-blind, placebo-controlled trial aims to evaluate the effects of two doses of intravenous dexmedetomidine administered during spinal anesthesia combined with ultrasound-guided pericapsular nerve group (PENG) block on autonomic regulation, systemic inflammatory response, postoperative pain, opioid consumption, and quality of recovery following elective primary total hip arthroplasty.
Eligibility
Primary outcome measure(s)
- Change in the Systemic Immune-Inflammation Index (SII) — 24 24 hours after surgery
Comparison of the change in the Systemic Immune-Inflammation Index (SII) from baseline to 24 hours after surgery among the three study groups.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Poznan University of Medical Sciences | Poznan | Poland |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07743853 on ClinicalTrials.gov ↗ ← All trials in Poland