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

NCT05718544 | Completed Phase 4 DMC

• 1 other identifier: 2023-017
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Scoliosis Correction; Postoperative analgesia; Esketamine; Dexmedetomidine; Chronic Postsurgical Pain

Outcome Measures

Primary Outcomes (1)

• Incidence of chronic postsurgical pain at 2 years after surgery

  Chronic postsurgical pain (CPSP) is defined as pain persisted for at least three months after surgery, that is not present before surgery or that has different characteristics, and other possible causes of the pain are excluded (e.g., cancer recurrence, infection).

  At 2 years after surgery

Secondary Outcomes (8)

• Severity of chronic pain at 2 years after surgery

  At 2 years after surgery

• Interference of chronic pain at 2 years after surgery

  At 2 years after surgery

• Proportion of chronic analgesic use after surgery

  Up to 2 years after surgery

• Proportion of analgesic use at 2 years after surgery

  At 2 years after surgery

• Subjective sleep quality at 2 years after surgery

  At 2 years after surgery

Study Arms (2)

Combined supplement

EXPERIMENTAL

Patient-controlled analgesia is established with esketamine 50 mg, dexmedetomidine 200 microgram, and sufentanil 4 microgram/kg (maximum 250 microgram), diluted with normal saline to 200 ml, and programmed to administer 2-ml boluses with a lockout interval of 8 minutes and a background infusion rate at 1 ml/h.

Drug: Esketamine; Drug: Dexmedetomidine; Drug: Sufentanil

Placebo

PLACEBO COMPARATOR

Patient-controlled analgesia is established with sufentanil 4 microgram/kg (maximum 250 microgram), diluted with normal saline to 200 ml, and programmed to administer 2-ml boluses with a lock-out interval of 8 minutes and a background infusion rate at 1 ml/h.

Drug: Sufentanil

Interventions

Esketamine DRUG

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

Combined supplement

Dexmedetomidine DRUG

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

Combined supplement

Sufentanil DRUG

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

Combined supplement; Placebo

Eligibility Criteria

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

You may qualify if:

• Patients aged ≥18 years;
• Scheduled for scoliosis correction surgery;
• Required patient-controlled intravenous analgesia (PCIA) after surgery.

You may not qualify if:

• Preoperative sick sinus syndrome, severe sinus bradycardia (heart rate \<50 beats per minute), atrioventricular block grade II or above without pacemaker, congenital heart disease, arrhythmia, or other serious cardiovascular diseases with a New York Heart Association class ≥III;
• Obstructive sleep apnea syndrome, or a STOP-Bang score ≥3 in combination with a serum bicarbonate level ≥28 mmol/L;
• Comorbid hyperthyroidism or pheochromocytoma;
• History of schizophrenia, epilepsy, myasthenia gravis;
• Preoperative delirium or communication barrier;
• Severe liver dysfunction (Child-Pugh grade C), severe renal dysfunction (preoperative dialysis), or American Society of Anaesthesiologists grade ≥IV;
• Body weight \<40 kg;
• Enrolled in other clinical studies;
• Loss to follow-up;
• Other conditions that were considered unsuitable for study participation.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (26)

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MeSH Terms

Conditions

Pain, Postoperative

Interventions

Esketamine; Dexmedetomidine; Sufentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fentanyl; Piperidines

Study Officials

• Dong-Xin Wang, MD,PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anesthesiology

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 8, 2023
• Study Start: January 30, 2023
• Primary Completion: September 7, 2023
• Study Completion: September 7, 2023
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)