Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator (NCT07743853) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator
Poland90 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
50 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 50-90 years.
* Scheduled for elective primary total hip arthroplasty due to primary hip osteoarthritis.
* American Society of Anesthesiologists (ASA) physical status I-III.
* Planned spinal anesthesia combined with ultrasound-guided Pericapsular Nerve Group (PENG) block.
* Ability to understand the study procedures and provide written informed consent.
Exclusion Criteria:
* Refusal to participate or inability to provide written informed consent.
* Contraindications to spinal anesthesia.
* Contraindications to PENG block.
* Allergy or hypersensitivity to dexmedetomidine, ropivacaine, bupivacaine, or study medications.
* Second- or third-degree atrioventricular block without a permanent pacemaker.
* Resting heart rate \<50 beats/min.
* Severe hepatic impairment (Child-Pugh class C).
* Severe renal failure requiring dialysis.
* Chronic opioid therapy (\>3 months before surgery).
* Chronic treatment with α2-adrenergic agonists.
* Cognitive impairment or inability to complete postoperative questionnaires.
* Infection at the injection site.
* Coagulopathy or ongoing anticoagulation precluding neuraxial anesthesia according to current guidelines.
* Revision total hip arthroplasty.
* Simultaneous bilateral total hip arthroplasty.
* Participation in another interventional clinical trial within the previous 30 days.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing whether an IV drug called dexmedetomidine can reduce inflammation during hip replacement surgery — can you explain what the Systemic Immune-Inflammation Index measures and why lowering it during my surgery might or might not matter for my recovery?
2Since this trial is listed as 'not yet recruiting,' how far away might it realistically be from actually enrolling patients, and should I be making treatment decisions now rather than waiting to see if I could participate?
3This trial is labeled Phase NA, which suggests it may not fit the standard drug-testing framework — can you help me understand what that means for how much we already know about the safety and effects of dexmedetomidine in this surgical setting?
4Dexmedetomidine affects both the immune system and the autonomic nervous system — given my specific health history, are there any reasons this kind of perioperative drug might carry particular risks for me that I should weigh carefully?
5If I am a candidate for hip replacement surgery, what does standard of care currently look like for managing surgical inflammation, and how does that compare to what this trial is trying to investigate?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Systemic Immune-Inflammation Index (SII)