Preemptive Analgesia Of Dexmedetomidine Reduces Per-operation Pain After Noncardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- The primary safety outcome
研究概览
简要总结
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)].
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years to 85 years old,
- •body mass index (BMI,calculated as weight in kilograms divided by height in meters squared): 18.5~
- •ASA (American Society of Anesthesiologists) Grade I- III;
- •Scheduled for non-cardiac surgery undergoing general anesthesia
- •expected duration of operation 0.5~3 h.
排除标准
- •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.
研究组 & 干预措施
Dexmedetomidine group
The DEX group was continuously pumped at 1.5 μg /(kg·h) for 15 minutes before induction, and after induction continue infusion 15min.
干预措施: Preemptive Dexmedetomidine injection (Drug)
Placebo group
the Placebo group was infused with equal amounts of 0.9% Sodium Chloride
干预措施: Sodium Chloride 0.9% Inj (Drug)
结局指标
主要结局
The primary safety outcome
时间窗: During 48 h post-operation
Adverse events and safety outcomes within during 48 h post-operation: hypotension, Hypertension,Bradycardia,Tachycardia,Respiratory depression,Pulse oxygen desaturation and the number of patients which need intervention.
The coprimary efficacy outcome
时间窗: post-operative 24 hours
The rate of none-to-slight post-operative pain, assessed with the (Numeric Rating Scale)p-NRS\< =3 at 24h post-opertively.
次要结局
- MAP(During the whole operation)
- EMG(During the whole operation)
- SBP(During the whole operation)
- mPONV(Postoperative immediately and until 12 hours post-operatively)
- Agitation(immediately afer surgery(Hour 0 post-operation))
- DBP(During the whole operation)
- Bispectral index(During the whole operation)
- pNRS at Hour 0, Hour 24, Hour 48, and the Day 7 postoperatively(post-operation p-NRS until 7 days(inculde Hour 0, Hour 24, Hour 48, and the Day 7 timepoints))
- Extubation time(after operation immediately)
- HR(During the whole operation)
- The accumulation of analgesia consumption(Hour 24, Hour 48, and the Day 7 after surgery)
- Dizziness(Hour 0, Hour 24 and the Hour 48 post-operatively)
- The rate of exhaust(until 24hours post-operation)