Preemptive Analgesia Of Dexmedetomidine Reduces Per-operation Pain

NCT ID: NCT06671327

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-03
• Study Completion Date: 2025-06-30

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.

Conditions

Pain Management; Noncardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Preemptive Dexmedetomidine injection

Intervention Type: DRUG

The DEX group was continuously pumped at 1.5 μg /(kg·h) for 15 minutes before induction, and after induction continue infusion 15min.

Placebo group

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

Group Type: PLACEBO_COMPARATOR

Sodium Chloride 0.9% Inj

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Sodium Chloride 0.9% Inj

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

Intervention Type: DRUG

Other Intervention Names

Preemptive Dex; Preemptive Sodium Chloride 0.9%

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China International Neuroscience Institution

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Yanghai Cui, prof

Role: CONTACT

1055885750@qq.com

+861083199270 ext. +8618196987786

Facility Contacts

Yanghai Cui, PHD

Role: primary

1055885750@qq.com

83199270 ext. 15010283592

Tianlong Wang, Doctor

Role: backup

w_tl5595@yeah.net

15910851623 ext. 15910851623

Other Identifiers

CINI-AD-2024-0112

Identifier Type: -

Identifier Source: org_study_id