drugset / Trial / NCT06671327

Preemptive Analgesia Of Dexmedetomidine Reduces Per-operation Pain

NCT06671327 ↗

Phase 4 Not yet recruiting 208 enrolled China International Neuroscience Institution
RandomizedParallel-groupQuadruple-blindHealth-services research

Summary

Background:Preemptive analgesia is the initiation of analgesic regimen before the onset of nociceptive stimulation, preventing the amplification of pain due to peripheral and central sensitization and thereby reducing subsequent pain. Preemptive analgesia of dexmedetomidine (DEX) in the epidural and subarachnoid space can effectively prevent the central sensitization, and significantly reduce the phantom limb pain, residual pain after one year of lower limb amputation. Objective: To investigate the per-operative effects of DEX preemptive analgesia. Method:The patients scheduled noncardiac surgery undergoing general anesthesia were selected and divided into DEX group and Placebo group randmized. The DEX group was continuously pumped at 1.5 μg /(kg·h) for 15 minutes before induction, and 15min after induction. The Placebo group was infused with equal amounts of normal saline.The Coprimary efficacy outcome was a composite of analgesia effect, one is the Compliance Rate of IOC2 target in intra-operation, another is the the rate of none-to-slight post-operative pain assessed with the p-NRS≦3 at 12 hours after surgery \[Pain numeric rating scale was assessed with the (Numeric Rating Scale, p-NRS)\].

Timeline

Start
2025-04-03
Primary completion
2025-06-23
Completion
2025-06-30

Outcome

Met primary endpoint

paper The DEX group demonstrated a significantly higher NOX compliance rate compared to the placebo group (98/108, 90.7% vs 14/112, 12.5%; P <.001). PMID 42207991 ↗

paper The incidence of NRS>3 was significantly lower in the DEX group at all postoperative time points (3/108, 2.8% vs 29/112, 25.9% at 0 hour; PMID 42207991 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 1.5 ug/kg Intravenous

Indications

No indication recorded.