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NCT Number: NCT06671327

Preemptive Analgesia Of Dexmedetomidine Reduces Per-operation Pain

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)].

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Key information

Conditions

Pain Management Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Noncardiac Surgery Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preemptive Dexmedetomidine injection

Drug

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

Sodium Chloride 0.9% Inj

Drug

The Placebo group was infused with equal amounts of isochronous normal saline.

Other names: Preemptive Sodium Chloride 0.9%

Primary outcomes

  1. The coprimary efficacy outcome

    Time frame: During the whole operation

    The rate of intro-operative IOC2 target reachment

  2. The coprimary efficacy outcome

    Time frame: 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.

  3. The primary safety outcome

    Time frame: 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.

Secondary outcomes

  1. SBP

    Time frame: During the whole operation

    systolic blood pressure(intraoperative hemodynamics)

  2. DBP

    Time frame: During the whole operation

    dystolic blood pressure(intraoperative hemodynamics)

  3. MAP

    Time frame: During the whole operation

    mean arterial pressure(intraoperative hemodynamics)

  4. HR

    Time frame: During the whole operation

    Heart rate (intraoperative hemodynamics)

  5. Bispectral index

    Time frame: During the whole operation

    Bispectral index

  6. EMG

    Time frame: During the whole operation

    Electromyogram Index

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

    Time frame: 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).

  8. mPONV

    Time frame: 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.

    • 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).

  9. The accumulation of analgesia consumption

    Time frame: 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.

  10. Dizziness

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

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

  11. Agitation

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

    Agitation immediately afer surgery(Hour 0 post-operation)

  12. The rate of exhaust

    Time frame: until 24hours post-operation

    The rate of exhaust at first 24hours post-operation

  13. Extubation time

    Time frame: after operation immediately

    Extubation time

Study contacts

Contact information is provided by the study sponsor or research team.

Yanghai Cui, prof

CONTACT

[email protected]

+861083199270 ext. +8618196987786

Sponsors and collaborators

Lead sponsor

China International Neuroscience Institution

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 4, 2024
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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