Preemptive Analgesia Of Dexmedetomidine Reduces Per-operation Pain
- Conditions
- Pain ManagementNoncardiac Surgery
- Interventions
- Drug: Sodium Chloride 0.9% Inj
- Registration Number
- NCT06671327
- Lead Sponsor
- China International Neuroscience Institution
- Brief 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 \[Pain numeric rating scale was assessed with the (Numeric Rating Scale, p-NRS)\].
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 208
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexmedetomidine group 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. Placebo group Sodium Chloride 0.9% Inj the Placebo group was infused with equal amounts of 0.9% Sodium Chloride
- Primary Outcome Measures
Name Time Method The primary safety outcome 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 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.
- Secondary Outcome Measures
Name Time Method MAP During the whole operation mean arterial pressure(intraoperative hemodynamics)
EMG During the whole operation Electromyogram Index
SBP During the whole operation systolic blood pressure(intraoperative hemodynamics)
mPONV Postoperative immediately and until 12 hours post-operatively modified postoperative nausea vomiting (mPONV) score at postoperative immediately (0 hour)and 24 hours post-operatively.
Modified PONV Scoring Criteria:
0 points: No nausea or vomiting.
1. point: Nausea present, no vomiting.
2. points: Nausea with one vomiting episode. Additional points: +1 per additional vomiting episode (e.g., 4 vomiting episodes = 5 points).Agitation immediately afer surgery(Hour 0 post-operation) Agitation immediately afer surgery(Hour 0 post-operation)
DBP During the whole operation dystolic blood pressure(intraoperative hemodynamics)
Bispectral index During the whole operation Bispectral index
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) Record and compared the pNRS at Hour 0, Hour 24, Hour 48, and the Day 7 postoperatively. (The p-NRS was an 11-point scale with 0 indicating no pain and 10 equaled worst pain).
Extubation time after operation immediately Extubation time
HR During the whole operation Heart rate (intraoperative hemodynamics)
The accumulation of analgesia consumption Hour 24, Hour 48, and the Day 7 after surgery The accumulation of analgesia consumption was used to describe oxycodone accumulation (oral administration of oxycodone 5 mg for each complaint of pain) at Hour 24, Hour 48, and the Day 7 after surgery.
Dizziness Hour 0, Hour 24 and the Hour 48 post-operatively Dizziness at Hour 0, Hour 24 and the Hour 48 post-operatively
The rate of exhaust until 24hours post-operation The rate of exhaust at first 24hours post-operation
Trial Locations
- Locations (1)
Xuanwu hospital
🇨🇳Beijing, Beijing, China