An interventional study of Dexmedetomidine and Saline in Total Knee Arthroplasty and Sedation, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-19.
Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Other
Dexmedetomidine is often used for sedation procedures. It has also been shown to have a pain-protective effect. Researchers predicted that using dexmedetomidine for sedation in total knee arthroplasties performed under spinal anesthesia would reduce the frequency of rebound pain and pain scores.
Randomization will take place before the patient enters the operating room. After spinal anesthesia is applied, 0.4 mcg/kg sedadomide loading will be done for 10 minutes in the sedation group, and then 0.4 mcg/kg/h sedadomide infusion will continue until the end of the surgery. Patients selected for the control group will be given the same amounts of saline. At the end of the surgical procedure, saline and sedadomide infusions will be stopped. All patients will undergo an adductor canal block under USG guidance in the recovery room. 50 mg of buvacin will be given to the block area. Patients will be fitted with a patient control analgesia device, which only provides bolus application and provides 20 mg of madol in each bolus. Postoperatively, sudden onset severe withdrawal pain outside the normal course of pain starting within 48 hours will be followed and Vas-bromage monitoring will be done at 0, 1, 2, 4, 8, 12, 24, 36, 48 hours.
Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.
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Exclusion Criteria:
Patients will receive the standardized pre-op meds and spinal anesthetic. Once the patient's spinal is performed, patient will receive the following: Start with bolus of 0.4 microgram/kg over 10 minutes, and then infusion of 0.4 microgram/kg/hr infusion will be stopped after the last staple or suture is performed on the incision. Interventions: Drug: Dexmedetomidine
Drug: Dexmedetomidine
Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo. Interventions: Drug: Normal Saline
Drug: Saline
Patient group to be given dexmedetomidine
Patient group to be given salin
Rebound pain VAS scores and incidence of rebound pain
Rebound pain-defined as transient acute postoperative pain within 12-24hrs that ensues following resolution of sensory blocked.
Time frame: 48 hours after surgery
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Ankara City Hospital Bilkent