Different Dose Esketamine and Dexmedetomidine Combination for Supplemental Analgesia After Scoliosis Correction Surgery

NCT06062550 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 2023-351
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

Scoliosis correction surgery is associated with severe pain. Patients after scoliosis correction surgery usually require high dose opioids and long duration analgesia, which may increase side effects and drug tolerance. In a recent trial, mini-dose esketamine and dexmedetomidine combination as a supplement to sufentanil significantly improved analgesia and subjective sleep quality after spinal correction surgery without increasing adverse events; however, the proportion of patients with moderate-to-severe pain remained high. The authors speculate that increasing esketamine dose in the combination may further improve analgesic effects.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pain intensity with movement and opioid consumption within 72 hours.

  A comprehensive index of pain intensity and opioid consumption is calculated. The range of the index is -200% to +200%; values above 0 indicate increased summed area under curve (AUC) and opioid consumption (OC) compared to the all patients.

  Within 72 hours after surgery

Secondary Outcomes (8)

• Proportion of patients with moderate to severe pain within 72 hours.

  Up to 72 hours after surgery.

• The highest NRS pain score within 72 hours after surgery.

  Up to 72 hours after surgery.

• Area under curve of NRS pain score within 72 hours after surgery.

  Up to 72 hours after surgery

• Cumulative opioid consumption within 72 hours after surgery.

  Up to 72 hours after surgery

• Requirement of supplement analgesia within 72 hours.

  Up to 72 hours after surgery

Other Outcomes (5)

• Agitation and sedation score at various timepoints after surgery.

  Up to the 5th day after surgery.

• Incidence of postoperative delirium within the first 5 days.

  Up to the 5th day after surgery.

• Depression severity at 7 days after surgery.

  At the 7th day after surgery.

Study Arms (3)

Low-dose group

ACTIVE COMPARATOR

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

Medium-dose group

EXPERIMENTAL

Patient-controlled analgesia is established with esketamine 100 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

High-dose group

EXPERIMENTAL

Patient-controlled analgesia is established with esketamine 150 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

Interventions

Esketamine DRUG

Different doses of esketamine in the esketamine-dexmedetomidine combination as a supplement to sufentanil for postoperative intravenous analgesia.

High-dose group; Low-dose group; Medium-dose group

Eligibility Criteria

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

You may qualify if:

• Aged ≥18 years and body weight ≥40 kg;
• Scheduled to undergo scoliosis correction with pedicle screw fixation;
• Required patient-controlled intravenous analgesia after surgery.

You may not qualify if:

• Preoperative sick sinus syndrome, severe sinus bradycardia (heart rate \<50 beats/min), atrioventricular block grade II or above without pacemaker; or comorbid with congenital heart disease, arrhythmia, or other serious cardiovascular diseases with a cardiac function grade ≥III;
• Patients with moderate and severe obstructive sleep apnea diagnosed preoperatively or according to the STOP-Bang score；
• History of hyperthyroidism and pheochromocytoma;
• History of schizophrenia, epilepsy, myasthenia gravis, or delirium;
• Severe liver dysfunction (child Pugh grade C), severe renal dysfunction (preoperative dialysis), or American Society of Anesthesiologists grade ≥IV;
• Barrier in communication;
• Other conditions that are considered unsuitable for study participation.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Beijing University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

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MeSH Terms

Conditions

Pain, Postoperative

Interventions

Esketamine

Condition Hierarchy (Ancestors)

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

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: September 25, 2023
• First Posted: October 2, 2023
• Study Start: October 24, 2023
• Primary Completion: October 23, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)