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Mini-dose Esketamine-dexmedetomidine Supplemented Analgesia and Long-term Outcomes

NCT05718544 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2025-07-30

No results posted yet for this study

Summary

Chronic postsurgical pain (CPSP) refers to pain that occurs or increases after surgery and lasts longer than 3 months. Severe postoperative acute pain is one of the major risk factors of CPSP. Spine surgery brings severe postoperative pain due to large trauma and long duration. Ketamine and esketamine are N-methyl-D-aspartate receptor antagonists; they have anti-hyperalgesic effects and may reduce CPSP. Dexmedetomidine is an alpha 2-adrenoceptor agonist with sedative, anxiolytic, and analgesic effect; it is frequently used as an adjuvant to postoperative analgesia. In a previous trial of the investigators, 200 patients following scoliosis correction surgery were randomzied to receive opioid analgsia supplemented with either mini-dose esketamine-dexmedetomidine combination or placebo. The results showed that esketamine-dexmedetomidine supplement analgesia significantly improved analgesia and sleep quality after surgery. This study is designed to test the hypothesis that mini-dose esketamine-dexmedetomidine supplemented analgesia may reduce CPSP at 2 years after scoliosis correction surgery.

Conditions

  • Scoliosis Correction
  • Postoperative Analgesia
  • Esketamine
  • Dexmedetomidine
  • Chronic Postsurgical Pain

Interventions

DRUG

Esketamine

Esketamine 50 mg is included in the mixture for patient-controlled analgesia.

DRUG

Dexmedetomidine

Dexmedetomidine 200 microgram is included in the mixture for patient-controlled analgesia.

DRUG

Sufentanil

Sufentanil 4 microgram/kg (maximum 250 microgram) is included in the mixture for patient-controlled analgesia.

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Dong-Xin Wang, MD,PhD · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-30
Primary Completion
2023-09-07
Completion
2023-09-07

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05718544 on ClinicalTrials.gov