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Not yet recruiting NCT07743853

Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator

No phase Interventional Hip Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo, Dexmedetomidine, Dexmedetomidine.
Who it may be relevant to
Registry conditions: Hip Osteoarthritis. Basic parameters: 50 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator in Total Hip Arthroplasty: a Randomized Double-Blind Trial

Overview

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.

Detailed description

Total hip arthroplasty is associated with substantial surgical stress resulting in activation of the sympathetic nervous system, neuroendocrine stress pathways, and systemic inflammation. Excessive perioperative autonomic activation contributes to inflammatory dysregulation, postoperative pain, opioid requirements, delayed functional recovery, and postoperative complications. Strategies capable of attenuating this autonomic stress response may therefore improve postoperative outcomes beyond conventional analgesia.

Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative, analgesic, sympatholytic, and anti-inflammatory properties. Experimental and clinical evidence suggests that intravenous dexmedetomidine may reduce sympathetic outflow, attenuate neuroendocrine stress responses, modulate cytokine release, and preserve autonomic homeostasis during the perioperative period. Nevertheless, prospective randomized studies evaluating its effects on both autonomic regulation and systemic inflammatory response in patients receiving contemporary regional anesthesia remain limited.

This prospective, randomized, double-blind, placebo-controlled trial will compare three perioperative strategies in patients undergoing elective primary total hip arthroplasty under spinal anesthesia combined with ultrasound-guided PENG block:

placebo, low-dose intravenous dexmedetomidine, high-dose intravenous dexmedetomidine. All patients will receive identical surgical, anesthetic, and multimodal analgesic management. Intravenous dexmedetomidine administration will constitute the only study intervention.

The primary objective is to determine whether intravenous dexmedetomidine attenuates the perioperative systemic inflammatory response as assessed by changes in the Systemic Immune-Inflammation Index (SII). Secondary objectives include evaluation of additional inflammatory biomarkers including neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), C-reactive protein (CRP), monocyte-to-lymphocyte ratio (MLR), Systemic Inflammation Response Index (SIRI), and Aggregate Index of Systemic Inflammation (AISI), together with perioperative hemodynamic stability, vasopressor requirements, postoperative pain intensity, opioid consumption, time to first rescue analgesia, quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire, postoperative nausea and vomiting, time to first ambulation, length of hospital stay, patient satisfaction, and postoperative complications.

The study is designed to investigate intravenous dexmedetomidine as a perioperative pharmacological autonomic-immune neuromodulatory strategy rather than solely an analgesic adjuvant. The findings may improve understanding of the relationship between autonomic regulation, systemic inflammation, and postoperative recovery, and contribute to optimization of perioperative multimodal anesthesia for patients undergoing total hip arthroplasty.

Interventions

  • Drug 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.
  • Drug 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.
  • Drug 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.

Primary outcome measures

  • Change in the Systemic Immune-Inflammation Index (SII) [Time frame: 24 24 hours after surgery]
Secondary outcome measures (12)
  • Change in Systemic Immune-Inflammation Index (SII) [Time frame: 12 hours after surgery]
  • Change in Systemic Immune-Inflammation Index (SII) [Time frame: 48 hours after surgery]
  • Neutrophil-to-Lymphocyte Ratio (NLR) [Time frame: 12 hours after surgery]
  • Neutrophil-to-Lymphocyte Ratio (NLR) [Time frame: 24 hours after surgery]
  • Neutrophil-to-Lymphocyte Ratio (NLR) [Time frame: 48 hours after surgery]
  • Platelet-to-Lymphocyte Ratio (PLR) [Time frame: 12 hours after surgery]
  • Platelet-to-Lymphocyte Ratio (PLR) [Time frame: 24 hours after surgery]
  • Platelet-to-Lymphocyte Ratio (PLR) [Time frame: 48 hours after surgery]
  • C-reactive protein (CRP) [Time frame: 24 hours after surgery]
  • Postoperative opioid consumption [Time frame: 48 hours after surgery]
  • Time to first rescue opioid analgesia [Time frame: 48 hours after surgery]
  • QoR-15 [Time frame: 24 hours after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Poland · 1 center
  • Poznan University of Medical Sciences — Poznan

Identifiers

NCT: NCT07743853 · 19/2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗