Preemptive Analgesia Of Dexmedetomidine Reduces Per-operation Pain

Официальное название

Preemptive Analgesia Of Dexmedetomidine Reduces Per-operation Pain After Noncardiac Surgery

Обзор

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 \[Pain numeric rating scale was assessed with the (Numeric Rating Scale, p-NRS)\].

Подробное описание

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 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.

Вмешательства

• Препарат Preemptive Dexmedetomidine injection
  The DEX group was continuously pumped at 1.5 μg /(kg·h) for 15 minutes before induction, and after induction continue infusion 15min.
• Препарат Sodium Chloride 0.9% Inj
  The Placebo group was infused with equal amounts of isochronous normal saline.

Первичные конечные точки

• The coprimary efficacy outcome [Срок оценки: During the whole operation]
• The coprimary efficacy outcome [Срок оценки: post-operative 24 hours]
• The primary safety outcome [Срок оценки: During 48 h post-operation]

Вторичные конечные точки (12)

• SBP [Срок оценки: During the whole operation]
• DBP [Срок оценки: During the whole operation]
• MAP [Срок оценки: During the whole operation]
• HR [Срок оценки: During the whole operation]
• Bispectral index [Срок оценки: During the whole operation]
• EMG [Срок оценки: During the whole operation]
• pNRS at Hour 0, Hour 24, Hour 48, and the Day 7 postoperatively [Срок оценки: post-operation p-NRS until 7 days(inculde Hour 0, Hour 24, Hour 48, and the Day 7 timepoints)]
• mPONV [Срок оценки: Postoperative immediately and until 12 hours post-operatively]
• The accumulation of analgesia consumption [Срок оценки: Hour 24, Hour 48, and the Day 7 after surgery]
• Dizziness [Срок оценки: Hour 0, Hour 24 and the Hour 48 post-operatively]
• Agitation [Срок оценки: immediately afer surgery(Hour 0 post-operation)]
• The rate of exhaust [Срок оценки: until 24hours post-operation]

Критерии участия

Критерии включения

• 18 years to 85 years old,
• body mass index (BMI,calculated as weight in kilograms divided by height in meters squared): 18.5\~35.
• ASA (American Society of Anesthesiologists) Grade I- III;
• Scheduled for non-cardiac surgery undergoing general anesthesia
• expected duration of operation 0.5\~3 h.

Критерии исключения

• disagreed to participate;
• body mass index (BMI) of greater 35
• American Society of Anesthesiologists (ASA) classification 4 or above;
• previous severe central nervous systemheart, liver, kidney or and lung dysfunction ;
• diagnosed neuropsychological disorders, that is, schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis，Alzheimer's disease and other autonomic disorders of patients affecting EEG outcomes;
• comatose, dementia, or language barrier which impeded communication and assessment;
• history of neurosurgical procedures;
• Systolic blood pressure continuously lower than 85mmHg or higher than 180mmHg; heart rate continuously lower than 45 times / min; sever arrhythmia need intervation and implantable pacemaker.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Организация здравоохранения

Центры проведения

Китай · 1 центр

• Xuanwu hospital — Пекин

Публикации

• Wang X, Chang H, Qi W, Wang H, Huang Y, Wu Z, Wang Q, Jiang W, Wang T. Dexmedetomidine Preemptive Analgesia on Intra- and Postoperative Pain in Noncardiac Surgery: A Randomized, Double-Blind, Controlled Study. Anesth Analg. 2026 May 28. doi: 10.1213/ANE.0000000000008078. Online ahead of print. PMID 42207991

Идентификаторы

NCT: NCT06671327 · CINI-AD-2024-0112

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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