Comparison of dexmedetomidine and ketamine on pain after total knee arthroplasty
| ISRCTN | ISRCTN11906298 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11906298 |
- Submission date
- 13/06/2025
- Registration date
- 13/06/2025
- Last edited
- 13/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
This study looked at two medications, dexmedetomidine and ketamine, to find out which one works better in reducing pain and the need for strong painkillers after knee replacement surgery (total knee arthroplasty). Both drugs are often used during surgery as part of a pain relief strategy called multimodal analgesia.
Who can participate?
Adults aged 18 years or over, who were scheduled for elective single-knee replacement surgery under spinal anesthesia and were physically fit
What does the study involve?
Participants were randomly placed into two groups. One group received dexmedetomidine, the other received ketamine, both during surgery. Everyone also received a femoral nerve block and standard spinal anesthesia. Pain levels, use of painkillers, vital signs, and satisfaction were monitored for 24 hours after surgery.
What are the possible benefits and risks of participating?
There may be better pain control and a lower need for opioids. No serious side effects were observed, and there were no cases of low blood pressure or slow heart rate. All patients reported high satisfaction.
Where is the study run from?
Hatay Mustafa Kemal University (Turkey)
When is the study starting and how long is it expected to run for?
June 2023 to December 2024
Who is funding the study?
Hatay Mustafa Kemal University (Turkey)
Who is the main contact?
Dr Senem Urfalı, senemurfali@gmail.com
Contact information
Public, Scientific, Principal Investigator
Madenli Mahallesi 3000.Sokak Borankent Sitesi C Blok Kat:2 Daire:4
Arsuz
Hatay
31225
Türkiye
 ORCID ID |
0000-0003-4500-2408 |
|---|---|
| Phone | +90 (0)5326331797 |
| senemurfali@gmail.com |
Study information
| Study design | Single-centre double-blinded prospective randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Comparing the effects of intraoperative dexmedetomidine and ketamine on postoperative pain in total knee arthroplasty: a randomized trial |
| Study acronym | DK-TKA |
| Study objectives | It was hypothesized that intraoperative dexmedetomidine infusion would provide better postoperative pain control and reduce opioid consumption compared to ketamine in patients undergoing total knee arthroplasty. |
| Ethics approval(s) |
Approved 21/06/2023, Hatay Mustafa Kemal University Clinical Research Ethics Committee (Tayfur Sökmen Kampüsü Alahan-Antakya/HATAY, Hatay, 31060, Türkiye; +90 (0)(326) 221 33 17 - 18 - 19; rektorlukyaziisleri@mku.edu.tr), ref: 02 |
| Health condition(s) or problem(s) studied | Total knee arthroplasty |
| Intervention | Patients were randomly allocated into two groups (1:1 ratio) using a computer-generated randomisation list created by an independent biostatistician before patient enrolment. Block randomisation was not used. Allocation was concealed, and both patients and outcome assessors were blinded to group assignments. Patients were randomly assigned to receive either intraoperative dexmedetomidine infusion (1 µg/kg over 10 minutes followed by 0.5 µg/kg/h) or ketamine infusion (0.1 mg/kg/h without a loading dose) under spinal anesthesia. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dexmedetomidine, ketamine |
| Primary outcome measure | Total opioid consumption (in milligrams of tramadol) is measured using data obtained from the intravenous PCA device at 24 hours postoperatively. |
| Secondary outcome measures | 1. Pain intensity is measured using the Visual Analogue Scale (VAS) (0 = no pain, 10 = worst pain) in both sitting and supine positions at 0, 4, 8, 12, 18, and 24 hours postoperatively 2. Need for rescue analgesia is determined based on VAS ≥4, and the administration of IV meperidine (0.3 mg/kg) is recorded during the first 24 hours 3. Hemodynamic parameters including heart rate, systolic, diastolic, and mean arterial pressure are measured using noninvasive monitoring at 0, 4, 8, 12, 18, and 24 hours postoperatively 4. Ambulation time (in hours) is recorded based on the time to first mobilization after surgery 5. Side effects including postoperative nausea and vomiting, hypotension, and bradycardia are documented based on clinical observation and medication use within the first 24 hours 6. Patient satisfaction is measured using a four-point scale (0 = poor, 1 = moderate, 2 = good, 3 = excellent) at 24 hours postoperatively |
| Overall study start date | 21/06/2023 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 110 Years |
| Sex | Both |
| Target number of participants | 104 |
| Total final enrolment | 104 |
| Key inclusion criteria | 1. Adult patients aged ≥18 years 2. Scheduled for elective unilateral primary total knee arthroplasty under spinal anesthesia 3. American Society of Anesthesiologists (ASA) physical status I–III 4. Provided written informed consent |
| Key exclusion criteria | 1. Body mass index (BMI) >35 kg/m² 2. Uncontrolled hypertension 3. Renal or hepatic disease 4. Mental, psychiatric or neuromuscular disorders 5. Known allergies or contraindications to dexmedetomidine, ketamine, or local anesthetics 6. Contraindications to spinal anesthesia 7. Refusal to participate in the study |
| Date of first enrolment | 01/07/2023 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Hatay
31060
Türkiye
Sponsor information
University/education
Tayfur Ata Sökmen Faculty of Medicine
Serinyol Mahallesi
Alahan-Antakya/ Hatay
31060
Türkiye
| Phone | +90 (326) 229 10 00, +90 (326) 221 33 17 - 18 - 19 |
|---|---|
| senemurfali@mku.edu.tr |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/08/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal upon completion of the study. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be available upon request from the corresponding author (please contact Dr Senem Urfalı via senemurfali@gmail.com). The data include anonymised individual participant data (IPD) related to demographics, intervention details, opioid consumption, VAS scores, and hemodynamic parameters. Data will become available after publication of the study results and will be accessible for a period of 5 years. Access will be granted for academic purposes following approval of a written proposal. Participant consent for data sharing was obtained as part of the informed consent process. All data will be anonymised to protect patient confidentiality and comply with ethical guidelines. |
Editorial Notes
13/06/2025: Study's existence confirmed by the Hatay Mustafa Kemal University Clinical Research Ethics Committee.
