Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator

NCT07743853 | Not Yet Recruiting

• 1 other identifier: 19/2026
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hip Osteoarthritis

Outcome Measures

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.

  24 24 hours after surgery

Secondary Outcomes (30)

• Change in Systemic Immune-Inflammation Index (SII)

  12 hours after surgery

• Change in Systemic Immune-Inflammation Index (SII)

  48 hours after surgery

• Neutrophil-to-Lymphocyte Ratio (NLR)

  12 hours after surgery

• Neutrophil-to-Lymphocyte Ratio (NLR)

  24 hours after surgery

• Neutrophil-to-Lymphocyte Ratio (NLR)

  48 hours after surgery

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants will receive intravenous placebo (0.9% saline) administered according to the study protocol during elective primary total hip arthroplasty performed under spinal anesthesia combined with ultrasound-guided Pericapsular Nerve Group (PENG) block. All participants will receive identical perioperative management and multimodal analgesia. Intravenous placebo is the only study intervention differing between groups.

Drug: Placebo

Low-dose Intravenous Dexmedetomidine

ACTIVE COMPARATOR

Participants will receive low-dose intravenous dexmedetomidine administered according to the study protocol during elective primary total hip arthroplasty performed under spinal anesthesia combined with ultrasound-guided Pericapsular Nerve Group (PENG) block. All participants will receive identical perioperative management and multimodal analgesia. Intravenous dexmedetomidine dose is the only study intervention differing between groups.

Drug: Dexmedetomidine

High-dose Intravenous Dexmedetomidine

ACTIVE COMPARATOR

Participants will receive high-dose intravenous dexmedetomidine administered according to the study protocol during elective primary total hip arthroplasty performed under spinal anesthesia combined with ultrasound-guided Pericapsular Nerve Group (PENG) block. All participants will receive identical perioperative management and multimodal analgesia. Intravenous dexmedetomidine dose is the only study intervention differing between groups.

Drug: Dexmedetomidine

Interventions

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.

Placebo

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.

Low-dose Intravenous Dexmedetomidine

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 62-701, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Malgorzata Reysner, MD PhD

  Poznan University of Medical Sciences

  STUDY CHAIR

Central Study Contacts

MAlgorzata Reysner, MD PhD

CONTACT

+48 61 8310122; mreysner@ump.edu.pl

Malgorzata Reysner, MD PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available beginning 6 months after publication of the primary study results and will remain available for 5 years.
• Access Criteria: Researchers who provide a scientifically sound research proposal consistent with the objectives of the original study will be granted access to de-identified individual participant data, study protocol, statistical analysis plan, and analytic code. Requests should be submitted to the corresponding author. Access will be granted following approval of the research proposal and execution of a data sharing agreement to ensure appropriate use of the shared data.

Locations

PL (1)