Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-90
SponsorPoznan University of Medical Sciences

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Drug

    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

    Drug

    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

    Drug

    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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Low-dose Intravenous DexmedetomidineActive comparator 1 intervention
Group C: High-dose Intravenous DexmedetomidineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in the Systemic Immune-Inflammation Index (SII)

Comparison of the change in the Systemic Immune-Inflammation Index (SII) from baseline to 24 hours after surgery among the three study groups.

Time frame
24 24 hours after surgery

Secondary outcomes

1

Change in Systemic Immune-Inflammation Index (SII)

Comparison of the change in the Systemic Immune-Inflammation Index (SII) from baseline to 12 hours after surgery

Time frame
12 hours after surgery
2

Change in Systemic Immune-Inflammation Index (SII)

Comparison of the change in the Systemic Immune-Inflammation Index (SII) from baseline to 48 hours after surgery

Time frame
48 hours after surgery
3

Neutrophil-to-Lymphocyte Ratio (NLR)

Neutrophil-to-lymphocyte ratio (NLR), calculated from routine peripheral blood counts

Time frame
12 hours after surgery
4

Neutrophil-to-Lymphocyte Ratio (NLR)

Neutrophil-to-lymphocyte ratio (NLR), calculated from routine peripheral blood counts

Time frame
24 hours after surgery

Other outcomes

Sponsors and contacts

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