Preemptive Analgesia Of Dexmedetomidine Reduces Per-operation Pain

NCT06671327 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: CINI-AD-2024-0112
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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

Conditions

Pain Management; Noncardiac Surgery

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• SBP

  During the whole operation

• DBP

  During the whole operation

• MAP

  During the whole operation

• HR

  During the whole operation

• Bispectral index

  During the whole operation

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

the Placebo group was infused with equal amounts of 0.9% Sodium Chloride

Drug: Sodium Chloride 0.9% Inj

Interventions

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.

Also known as: Preemptive Dex

Dexmedetomidine group

Sodium Chloride 0.9% Inj DRUG

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

Also known as: Preemptive Sodium Chloride 0.9%

Placebo group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China International Neuroscience Institution: lead

Study Sites (1)

Xuanwu hospital

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Agnosia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Yanghai Cui, prof

CONTACT

+861083199270; 1055885750@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: November 4, 2024
• Study Start: April 3, 2025
• Primary Completion: June 23, 2025
• Study Completion: June 30, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-03

Locations

CN (1)