Preemptive Analgesia Of Dexmedetomidine Reduces Per-operation Pain

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

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 Overview

• Status: Not yet recruiting
• Conditions: Pain Management; Noncardiac Surgery
• Intervention / Treatment: Drug: Preemptive Dexmedetomidine injection; Drug: Sodium Chloride 0.9% Inj

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.

• Study Type: Interventional
• Enrollment (Estimated): 208
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yanghai Cui, prof; Phone Number: +8618196987786 +861083199270; Email: 1055885750@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital
      • Contact: Yanghai Cui, PHD; Phone Number: 15010283592 83199270; Email: 1055885750@qq.com
      • Contact: Tianlong Wang, Doctor; Phone Number: 15910851623 15910851623; Email: w_tl5595@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: Preemptive Dex
Placebo Comparator: Placebo group; the Placebo group was infused with equal amounts of 0.9% Sodium Chloride	Drug: Sodium Chloride 0.9% Inj; The Placebo group was infused with equal amounts of isochronous normal saline.; Other Names: Preemptive Sodium Chloride 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The coprimary efficacy outcome	The rate of intro-operative IOC2 target reachment	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.	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.	During 48 h post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SBP	systolic blood pressure(intraoperative hemodynamics)	During the whole operation
DBP	dystolic blood pressure(intraoperative hemodynamics)	During the whole operation
MAP	mean arterial pressure(intraoperative hemodynamics)	During the whole operation
HR	Heart rate (intraoperative hemodynamics)	During the whole operation
Bispectral index	Bispectral index	During the whole operation
EMG	Electromyogram Index	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).	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.; point: Nausea present, no vomiting.; points: Nausea with one vomiting episode. Additional points: +1 per additional vomiting episode (e.g., 4 vomiting episodes = 5 points).	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.	Hour 24, Hour 48, and the Day 7 after surgery
Dizziness	Dizziness at Hour 0, Hour 24 and the Hour 48 post-operatively	Hour 0, Hour 24 and the Hour 48 post-operatively
Agitation	Agitation immediately afer surgery(Hour 0 post-operation)	immediately afer surgery(Hour 0 post-operation)
The rate of exhaust	The rate of exhaust at first 24hours post-operation	until 24hours post-operation
Extubation time	Extubation time	after operation immediately

Collaborators and Investigators

• Sponsor: China International Neuroscience Institution

Study record dates

Study Major Dates

• Study Start (Estimated): April 3, 2025
• Primary Completion (Estimated): June 23, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine
• Other Study ID Numbers: CINI-AD-2024-0112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No