Optimal dose of oxycodone combined with dexmedetomidine for analgesia
| ISRCTN | ISRCTN13115201 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13115201 |
| Sponsor | Beijing Chuiyangliu Hospital |
| Funder | Enze Pain Management Medical Research Project of Bethune Charity Foundation (ezmr2022-062) |
- Submission date
- 21/05/2026
- Registration date
- 03/06/2026
- Last edited
- 28/05/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Objective: Evidence on optimal oxycodone dosing with dexmedetomidine for patients aged ≥75 years undergoing percutaneous kyphoplasty (PKP) is lacking. This randomized, double-blind trial compared three oxycodone doses (0.03, 0.05, 0.07 mg/kg) to identify the optimal analgesic ceiling.
Methods: 150 patients (≥75 years, American Society of Anesthesiologists (ASA) II–III) were randomized into three groups (n=50 each) to receive intravenous oxycodone at 0.03 (L), 0.05 (M), or 0.07 (H) mg/kg, plus dexmedetomidine (0.5 μg/kg loading, 0.2 μg/kg/h maintenance). Primary outcome: Numerical Rating Scale (NRS) pain scores at five perioperative time points. Secondary outcomes: hemodynamics, bispectral index (BIS), Modified Observer's Assessment of Alertness/Sedation (MOAA/S), adverse events, and patient/surgeon satisfaction.
Results: At T2 (trocar insertion), M and H had lower NRS than L (P<0.05), with no difference between M and H. At T3, H was lower than L (P<0.05), but M vs. L showed no difference. MOAA/S was lowest in H (P<0.0001), but all groups had median 4 (arousable sedation). Respiratory depression was higher in H (14.0%) than L (2.0%) and M (4.0%) (P=0.033). PONV was numerically highest in H (12.0% vs. 4.0% and 6.0%, P>0.05). Group M achieved the highest patient and surgeon satisfaction (P<0.05).
Conclusion: Oxycodone 0.05 mg/kg combined with dexmedetomidine provides maximal pain relief and satisfaction with a favorable safety profile, representing the optimal analgesic ceiling for PKP in patients aged ≥75 years.
Contact information
Scientific, Public, Principal investigator
No. 2, Chiyangliu South Street, Chaoyang District
Beijing
100022
China
| Phone | +86 (0)15110224069 |
|---|---|
| yangwy0026@126.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Dose comparison |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Optimal dose of oxycodone combined with dexmedetomidine for analgesia in septuagenarians undergoing percutaneous kyphoplasty: a randomized controlled trial |
| Study objectives | Evidence on optimal oxycodone dosing with dexmedetomidine for patients aged ≥75 years undergoing percutaneous kyphoplasty (PKP) is lacking. This randomized, double-blind trial compared three oxycodone doses (0.03, 0.05, 0.07 mg/kg) to identify the optimal analgesic ceiling. |
| Ethics approval(s) |
Approved 01/06/2022, Medical Ethics Committee of Beijing Chuiyangliu Hospital (No. 2, Chiyangliu South Street, Chaoyang District, Beijing, 100022, China; +86 (0)15110224068; cylkj@bjchy.gov.cn), ref: 2022-009KY |
| Health condition(s) or problem(s) studied | Percutaneous kyphoplasty (PKP) |
| Intervention | Eligible patients were randomly assigned to one of three groups (L, M and H) in a 1:1:1 ratio. A computer-generated randomization sequence was created by an independent statistician using SPSS version 26.0 (IBM Corp., Armonk, NY, USA) with random block sizes of 6 to ensure balance. Upon arrival in the operating room, all patients received supplemental oxygen via a face mask (flow rate: 3 l/min). Peripheral venous access was established, and continuous monitoring was initiated, including electrocardiography (ECG), non-invasive blood pressure (BP), pulse oxygen saturation (SpO₂), and the bispectral index (BIS). Following a 5-minute quiet rest period, baseline BP and heart rate (HR) were calculated as the mean of two consecutive measurements at 2-minute intervals and recorded as the baseline values at T0. A loading dose of dexmedetomidine (0.2 μg/kg) was administered intravenously to all patients over a 15-minute period. Given the relatively short duration of the procedure, no continuous maintenance infusion was employed. Patients were subsequently assisted into the prone position. During skin disinfection, patients in Groups L, M, and H received slow intravenous injections of oxycodone at doses of 0.03, 0.05, and 0.07 mg/kg, respectively, with an injection duration of no less than 2 minutes. Local infiltration anesthesia was performed by the surgeon using 20–30 ml of 1% lidocaine, targeting the extra-pedicular area of the corresponding segments with layer-by-layer infiltration from the skin to the vertebral periosteum. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Oxycodone |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 01/01/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Senior |
| Lower age limit | 75 Years |
| Upper age limit | 95 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Total final enrolment | 150 |
| Key inclusion criteria | 1. Age ≥75 years 2. Confirmed diagnosis of osteoporotic vertebral compression fracture (OVCF) by imaging (X-ray, CT, or MRI) 3. Elective single-segment PKP surgery indicated 4. American Society of Anesthesiologists (ASA) physical status II–III 5. Voluntary written informed consent obtained from the patient or a legal proxy |
| Key exclusion criteria | 1. Severe cardiac or cerebrovascular diseases 2. Significant hepatic or renal impairment (defined as Child-Pugh class C or a glomerular filtration rate <30 ml/min/1.73 m²) 3. A history of chronic pain or opioid dependence 4. Known hypersensitivity to the study medications |
| Date of first enrolment | 01/01/2023 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
21/05/2026: Study's existence confirmed by the Medical Ethics Committee of Beijing Chuiyangliu Hospital.
