Preemptive Analgesia Of Dexmedetomidine Reduces Per-operation Pain

Phase 4Not Yet RecruitingNCT06671327

China International Neuroscience Institution208 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

QUADRUPLE

Enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The coprimary efficacy outcome

The rate of intro-operative IOC2 target reachment

Time frame: During the whole operation

The coprimary efficacy outcome

The rate of none-to-slight post-operative pain, assessed with the (Numeric Rating Scale)p-NRS\< =3 at 24h post-opertively.

Time frame: post-operative 24 hours

The primary safety outcome

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.

Time frame: During 48 h post-operation

Secondary Outcomes

SBP

systolic blood pressure(intraoperative hemodynamics)

Time frame: During the whole operation

DBP

dystolic blood pressure(intraoperative hemodynamics)

Time frame: During the whole operation

MAP

mean arterial pressure(intraoperative hemodynamics)

Time frame: During the whole operation

Heart rate (intraoperative hemodynamics)

Time frame: During the whole operation

Bispectral index

Time frame: During the whole operation

EMG

Electromyogram Index

Time frame: During the whole operation

pNRS at Hour 0, Hour 24, Hour 48, and the Day 7 postoperatively

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).

Time frame: post-operation p-NRS until 7 days(inculde Hour 0, Hour 24, Hour 48, and the Day 7 timepoints)

mPONV

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).

Time frame: Postoperative immediately and until 12 hours post-operatively

The accumulation of analgesia consumption

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.

Time frame: Hour 24, Hour 48, and the Day 7 after surgery

Dizziness

Dizziness at Hour 0, Hour 24 and the Hour 48 post-operatively

Time frame: Hour 0, Hour 24 and the Hour 48 post-operatively

Agitation

Agitation immediately afer surgery(Hour 0 post-operation)

Time frame: immediately afer surgery(Hour 0 post-operation)

The rate of exhaust

The rate of exhaust at first 24hours post-operation

Time frame: until 24hours post-operation

Extubation time

Time frame: after operation immediately

Preemptive Analgesia Of Dexmedetomidine Reduces Per-operation Pain

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts