Hip OsteoarthritisNCT07743853
Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator
A study testing Dexmedetomidine in people with Hip Osteoarthritis, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 1 Aug 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malgorzata Reysner, MD PhD contact
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Medical Sciences
Poznan, 62-701
Malgorzata Reysner, M.D. Ph.D., +48 61 873 83 03, mreysner@ump.edu.pl
About this study
Official title: Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator in Total Hip Arthroplasty: a Randomized Double-Blind 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.
Read the 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.
- Conditions
- Hip Osteoarthritis
- Being tested
- Placebo, Dexmedetomidine
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
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.
DexmedetomidineDrug
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.
DexmedetomidineDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 24 hours after surgery
Secondary outcomes (30)
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
Measured: 12 hours after surgery
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
Measured: 48 hours after surgery
Neutrophil-to-Lymphocyte Ratio (NLR)
Neutrophil-to-lymphocyte ratio (NLR), calculated from routine peripheral blood counts
Measured: 12 hours after surgery
Neutrophil-to-Lymphocyte Ratio (NLR)
Neutrophil-to-lymphocyte ratio (NLR), calculated from routine peripheral blood counts
Measured: 24 hours after surgery
Neutrophil-to-Lymphocyte Ratio (NLR)
Neutrophil-to-lymphocyte ratio (NLR), calculated from routine peripheral blood counts
Measured: 48 hours after surgery
Platelet-to-Lymphocyte Ratio (PLR)
Platelet-to-lymphocyte ratio (NLR), calculated from routine peripheral blood counts
Measured: 12 hours after surgery
Platelet-to-Lymphocyte Ratio (PLR)
Platelet-to-lymphocyte ratio (NLR), calculated from routine peripheral blood counts
Measured: 24 hours after surgery
Platelet-to-Lymphocyte Ratio (PLR)
Platelet-to-lymphocyte ratio (NLR), calculated from routine peripheral blood counts
Measured: 48 hours after surgery
C-reactive protein (CRP)
postoperative C-reactive protein (CRP) concentrations
Measured: 24 hours after surgery
Postoperative opioid consumption
Cumulative postoperative opioid consumption expressed as intravenous morphine milligram equivalents (MME).
Measured: 48 hours after surgery
Time to first rescue opioid analgesia
Comparison of the time from the end of surgery to the first administration of rescue opioid analgesia among the three study groups.
Measured: 48 hours after surgery
QoR-15
Comparison of postoperative quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire among the three study groups.
Measured: 24 hours after surgery
QoR-15
Comparison of postoperative quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire among the three study groups.
Measured: 48 hours after surgery
Postoperative pain intensity at rest
Comparison of postoperative pain intensity at rest assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, among the three study groups.
Measured: 2 hours after surgery
Postoperative pain intensity at rest
Comparison of postoperative pain intensity at rest assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, among the three study groups.
Measured: 6 hours after surgery
Postoperative pain intensity at rest
Comparison of postoperative pain intensity at rest assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, among the three study groups.
Measured: 12 hours after surgery
Postoperative pain intensity at rest
Comparison of postoperative pain intensity at rest assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, among the three study groups.
Measured: 24 hours after surgery
Postoperative pain intensity at rest
Comparison of postoperative pain intensity at rest assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, among the three study groups.
Measured: 48 hours after surgery
Postoperative pain intensity at movement
Comparison of postoperative pain intensity at rest assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, among the three study groups.
Measured: 2 hours after surgery
Postoperative pain intensity at movement
Comparison of postoperative pain intensity at rest assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, among the three study groups.
Measured: 6 hours after surgery
Postoperative pain intensity at movement
Comparison of postoperative pain intensity at rest assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, among the three study groups.
Measured: 12 hours after surgery
Postoperative pain intensity at movement
Comparison of postoperative pain intensity at rest assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, among the three study groups.
Measured: 24 hours after surgery
Postoperative pain intensity at movement
Comparison of postoperative pain intensity at rest assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, among the three study groups.
Measured: 48 hours after surgery
Incidence of postoperative nausea and vomiting
Comparison of the incidence of postoperative nausea and vomiting (PONV) within the first 48 hours after surgery among the three study groups.
Measured: 48 haours after surgery
Intraoperative vasopressor requirement
Comparison of cumulative vasopressor requirements administered to maintain adequate arterial blood pressure during surgery.
Measured: durring surgery
Incidence of intraoperative hypotension
Comparison of the incidence of intraoperative hypotension defined as a mean arterial pressure below 65 mmHg requiring therapeutic intervention.
Measured: durring surgery
Systemic Inflammation Response Index (SIRI)
Comparison of the Systemic Inflammation Response Index (SIRI), calculated from routine peripheral blood counts, among the three study groups as a marker of the perioperative systemic inflammatory response.
Measured: 24 hours after surgery
Systemic Inflammation Response Index (SIRI)
Comparison of the Systemic Inflammation Response Index (SIRI), calculated from routine peripheral blood counts, among the three study groups as a marker of the perioperative systemic inflammatory response.
Measured: 48 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
Comparison of the Aggregate Index of Systemic Inflammation (AISI), calculated from routine peripheral blood counts, among the three study groups as a marker of the perioperative systemic inflammatory response.
Measured: 24 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
Comparison of the Aggregate Index of Systemic Inflammation (AISI), calculated from routine peripheral blood counts, among the three study groups as a marker of the perioperative systemic inflammatory response.
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Aug 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malgorzata Reysner, MD PhD, Study chair, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743853
- Sponsor's protocol ID
- 19/2026
- Status last verified
- Nov 2026
- First submitted
- 29 Jul 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be made available upon reasonable request to the corresponding author. Data will be shared after publication of the primary study results following approval of a methodologically sound research proposal and completion of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator in Total Hip Arthroplasty: a Randomized Double-Blind Trial
- ClinicalTrials.gov ID
- NCT07743853
- Acronym / sponsor ID
- 19/2026
- Conditions
- Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
| Low-dose Intravenous Dexmedetomidine | Active comparator | Drug: DexmedetomidineParticipants 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. |
| High-dose Intravenous Dexmedetomidine | Active comparator | Drug: DexmedetomidineParticipants 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboIntravenous 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 | Placebo |
| DexmedetomidineIntravenous 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 | Low-dose Intravenous Dexmedetomidine |
| DexmedetomidineIntravenous 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. | Drug | High-dose Intravenous Dexmedetomidine |
Primary outcome
Change in the Systemic Immune-Inflammation Index (SII)
Time frame: 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.
30 secondary outcomes
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
QoR-15
Time frame: 48 hours after surgery
Postoperative pain intensity at rest
Time frame: 2 hours after surgery
Postoperative pain intensity at rest
Time frame: 6 hours after surgery
Postoperative pain intensity at rest
Time frame: 12 hours after surgery
Postoperative pain intensity at rest
Time frame: 24 hours after surgery
Postoperative pain intensity at rest
Time frame: 48 hours after surgery
Postoperative pain intensity at movement
Time frame: 2 hours after surgery
Postoperative pain intensity at movement
Time frame: 6 hours after surgery
Postoperative pain intensity at movement
Time frame: 12 hours after surgery
Postoperative pain intensity at movement
Time frame: 24 hours after surgery
Postoperative pain intensity at movement
Time frame: 48 hours after surgery
Incidence of postoperative nausea and vomiting
Time frame: 48 haours after surgery
Intraoperative vasopressor requirement
Time frame: durring surgery
Incidence of intraoperative hypotension
Time frame: durring surgery
Systemic Inflammation Response Index (SIRI)
Time frame: 24 hours after surgery
Systemic Inflammation Response Index (SIRI)
Time frame: 48 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
Time frame: 24 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
Time frame: 48 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be made available upon reasonable request to the corresponding author. Data will be shared after publication of the primary study results following approval of a methodologically sound research proposal and completion of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Malgorzata Reysner, MD PhD contact
Malgorzata Reysner, MD PhD study chair
Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Hip Osteoarthritis, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MAlgorzata Reysner, MD PhD (+48 61 8310122, mreysner@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Systemic Immune-Inflammation Index (SII) (time frame: 24 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.