Different Dose Esketamine and Dexmedetomidine for Supplemental Analgesia and Longterm Outcomes

NCT06087510 | Recruiting Phase 4 DMC

• 1 other identifier: 2023-351-2
• Study Type: interventional
• Target: 312
• 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 acute postoperative pain is one of the major risk factors of CPSP. Spinal correction surgery is associated with severe pain due to large trauma and long duration. Ketamine and esketamine are N-methyl-D-aspartate receptor antagonists; they have antihyperalgesic 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 200 patients after scoliosis correction surgery, mini-dose esketamine-dexmedetomidine in combination with opioids significantly improved analgesia and sleep quality but did not reduce CPSP. The authors speculate that increasing esketamine dose in the combination may further improve analgesia and, therefore, reduce the occurrence of CPSP.

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 3 months 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 3 months after surgery.

Secondary Outcomes (7)

• Incidence of chronic postsurgical pain at 6 or 12 months after surgery.

  At 6 or 12 months after surgery.

• Severity of chronic pain at 3, 6, and 12 months after surgery.

  At 3, 6, and 12 months after surgery.

• Proportion of chronic analgesic use after surgery.

  At 3, 6, and 12 months after surgery.

• Subjective sleep quality at 3, 6, and 12 months after surgery.

  At 3, 6, and 12 months after surgery.

• Severity of depression at 3, 6, and 12 months after surgery.

  At 3, 6, and 12 months 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 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:

• Patients aged ≥18 years and body weight≥40 kg;
• Scheduled to undergo scoliosis correction with pedicle screw fixation;
• 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;
• Patients with moderate or severe obstructive sleep apnea diagnosed preoperatively or according to the STOP-Bang score;
• History of hyperthyroidism or pheochromocytoma;
• History of schizophrenia, epilepsy, myasthenia gravis;
• Severe liver dysfunction (Child-Pugh grade C), severe renal dysfunction (preoperative dialysis), or American Society of Anaesthesiologists grade ≥IV;
• Barrier in communication;
• Other conditions that were considered unsuitable for study participation.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Beijing University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Related Publications (28)

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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

Central Study Contacts

Dong-Xin Wang, MD, PhD

CONTACT

8610-83572784; wangdongxin@hotmail.com

Fan Cui, MD

CONTACT

8610-83572460; cuifan_1987@163.com

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: October 11, 2023
• First Posted: October 17, 2023
• Study Start: January 24, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)