Clinical trial NCT06671327: Preemptive Analgesia Of Dexmedetomidine Reduces Per-operation Pain
Official title: Preemptive Analgesia Of Dexmedetomidine Reduces Per-operation Pain After Noncardiac Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Pain Management
Noncardiac Surgery
Lead sponsor: China International Neuroscience Institution
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The coprimary efficacy outcome
timeFrame: During the whole operation
measure: The coprimary efficacy outcome
timeFrame: post-operative 24 hours
measure: The primary safety outcome
timeFrame: During 48 h post-operation
Secondary outcomes:
measure: SBP
timeFrame: During the whole operation
measure: DBP
timeFrame: During the whole operation
measure: MAP
timeFrame: During the whole operation
measure: HR
timeFrame: During the whole operation
measure: Bispectral index
timeFrame: During the whole operation
measure: EMG
timeFrame: During the whole operation
measure: pNRS at Hour 0, Hour 24, Hour 48, and the Day 7 postoperatively
timeFrame: post-operation p-NRS until 7 days(inculde Hour 0, Hour 24, Hour 48, and the Day 7 timepoints)
measure: mPONV
timeFrame: Postoperative immediately and until 12 hours post-operatively
measure: The accumulation of analgesia consumption
timeFrame: Hour 24, Hour 48, and the Day 7 after surgery
measure: Dizziness
timeFrame: Hour 0, Hour 24 and the Hour 48 post-operatively
measure: Agitation
timeFrame: immediately afer surgery(Hour 0 post-operation)
measure: The rate of exhaust
timeFrame: until 24hours post-operation
measure: Extubation time
timeFrame: after operation immediately
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu hospital
state: Beijing
Study officials:
References: