Dexmedetomidine-esketamine Combination and Chronic Postsurgical Pain After Spinal Surgery

NCT07525999 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2026-0136-LT
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal surgery is generally followed by severe postoperative pain, and poor pain control may cause adverse outcomes such as cardiovascular events, neurocognitive disorders, and chronic postsurgical pain (CPSP). In previous studies, perioperative use of dexmedetomidine or esketamine is each associated with improved analgesia after surgery. Recent studies suggest that combined use of dexmedetomidine and esketamine may produce synergetic effects in improving analgesia. This trial is designed to test the hypothesis that perioperative combined use of dexmedetomidine and esketamine may reduce CPSP in patients after spinal surgery.

Conditions

Spinal Surgery; Pain Intensity; Dexmedetomidine; Esketamine; Postoperative Analgesia

Keywords

Spinal surgery; Pain intensity; Dexmedetomidine; Esketamine; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Incidence of chronic pain at 3 months after surgery

  Chronic post-spinal surgery pain is a specific type of Chronic Postsurgical Pain (CPSP), defined as pain lasting \>=3 months postoperatively after exclusion of other known causes. The presence of persistent pain beyond the postoperative recovery period is confirmed if any one of the following three criteria is met (either alone or in combination): 1. Any additional lumbar spine surgery within 3 months after the index surgery; 2. At least one pain-related physician visit within 3 months after the index surgery; 3. Any other surgical intervention for pain management at any time after surgery (not limited to 24 months), such as neuromodulation or implantation of a drug delivery system.

  Up to 3 months after surgery.

Secondary Outcomes (1)

• Incidence of chronic pain at 6 months after surgery

  Up to 6 months after surgery.

Other Outcomes (3)

• Pain scores (Numerical Rating Scale, NRS) at 3 and 6 months after surgery

  Up to 6 months after surgery.

• Incidence of neurocognitive disorders at 3 and 6 months postoperatively

  Up to 6 months after surgery.

• Oswestry Disability Index (ODI) at 3 and 6 months postoperatively

  Up to 6 months after surgery.

Study Arms (2)

Combined dexmedetomidine-esketamine group

EXPERIMENTAL

During anesthesia, a loading dose (0.2 ml/kg) of dexmedetomidine-esketamine (DEX-ESK) combination (DEX 2 ug/ml; ESK 1 mg/ml) will be infused after anesthesia induction (DEX 0.4 ug/kg; ESK 0.2 mg/kg), followed by a continuous infusion at 0.1 ml/kg/h (DEX 0.2 ug/kg/h; ESK 0.1 mg/kg/h) until 1 hour before the expected end of surgery. After surgery, patient-controlled intravenous analgesia will be established with dexmedetomidine (DEX 1.5 ug/ml), esketamine (ESK 0.5 mg/ml), and sufentanil (1.25 ug/ml), programmed to deliver 2-ml boluses (DEX 3.0 ug, ESK 1 mg, and sufentanil 2.5 ug) with a 8-10-minute lockout interval and a 1-ml/h (DEX 1.5 ug/h, ESK 0.5 mg/h, and 1.25 ug/h sufentanil) background infusion, and used for up to 48 hours.

Drug: Combined dexmedetomidine-esketamine administration

Placebo group

PLACEBO COMPARATOR

During anesthesia, a loading dose (0.2 ml/kg) of normal saline will be infused after anesthesia induction, followed by a continuous infusion at 0.1 ml/kg/h until 1 hour before the expected end of surgery. After surgery, patient-controlled intravenous analgesia will be established with sufentanil (1.25 ug/ml), programmed to deliver 2-ml boluses (sufentanil 2.5 ug) with a 8-10-minute lockout interval and a 1-ml/h (1.25 ug/h sufentanil) background infusion, and used for up to 48 hours.

Drug: Placebo administration

Interventions

Placebo administration DRUG

During anesthesia, a loading dose (0.2 ml/kg) of normal saline will be infused after anesthesia induction, followed by a continuous infusion at 0.1 ml/kg/h until 1 hour before the expected end of surgery. After surgery, patient-controlled intravenous analgesia will be established with sufentanil (1.25 ug/ml), programmed to deliver 2-ml boluses (sufentanil 2.5 ug) with a 8-10-minute lockout interval and a 1-ml/h (1.25 ug/h sufentanil) background infusion, and used for up to 48 hours.

Also known as: Placebo (normal saline)

Placebo group

Combined dexmedetomidine-esketamine administration DRUG

During anesthesia, a loading dose (0.2 ml/kg) of dexmedetomidine-esketamine (DEX-ESK) combination (DEX 2 ug/ml; ESK 1 mg/ml) will be infused after anesthesia induction (DEX 0.4 ug/kg; ESK 0.2 mg/kg), followed by a continuous infusion at 0.1 ml/kg/h (DEX 0.2 ug/kg/h; ESK 0.1 mg/kg/h) until 1 hour before the expected end of surgery. After surgery, patient-controlled intravenous analgesia will be established with dexmedetomidine (DEX 1.5 ug/ml), esketamine (ESK 0.5 mg/ml), and sufentanil (1.25 ug/ml), programmed to deliver 2-ml boluses (DEX 3.0 ug, ESK 1 mg, and sufentanil 2.5 ug) with a 8-10-minute lockout interval and a 1-ml/h (DEX 1.5 ug/h, ESK 0.5 mg/h, and 1.25 ug/h sufentanil) background infusion, and used for up to 48 hours.

Also known as: Dexmedetomidine and esketamine

Combined dexmedetomidine-esketamine group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \>= 40 years and \< 80 years;
• Scheduled to undergo elective posterior cervical, thoracic or lumbar spine surgery under general anesthesia, with an expected operative duration \>= 2 hours;
• Requirement for patient-controlled intravenous analgesia (PCIA) postoperatively.

You may not qualify if:

• Severe uncontrolled hypertension preoperatively (baseline ward blood pressure: SBP \> 180 mmHg or DBP \> 110 mmHg);
• Severe bradycardia (heart rate \<= 50 bpm), sick sinus syndrome, atrioventricular block of grade II or higher without pacemaker implantation, or a history of myocardial infarction within one year, severe heart failure (NYHA class \>= III), or rapid ventricular arrhythmia;
• Preoperative history of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or intracranial hypertension;
• Preoperative history of hyperthyroidism or pheochromocytoma;
• Inability to communicate preoperatively due to coma, severe dementia, or language impairment;
• Severe cardiac insufficiency (preoperative LVEF \< 30% or NYHA class IV), severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (preoperative dialysis), or ASA physical status \>= grade IV;
• Other conditions deemed inappropriate for study participation by the investigator or attending physician.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (48)

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MeSH Terms

Conditions

Pain

Interventions

Dexmedetomidine; Esketamine; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Xin Wang, MD, PhD

CONTACT

01083572784; wangdongxin@hotmail.com

Huai-Jin Li, MD

CONTACT

sophie.lee.coffee@gmail.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: Chief Physician, Professor

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)