NCT07523321

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 improve analgesia and reduce moderate-to-severe pain in patients after spinal surgery.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for phase_4

Timeline
10mo left

Started Apr 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Apr 2026May 2027

Study Start

First participant enrolled

April 1, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 4, 2026

Last Update Submit

April 9, 2026

Conditions

Spinal SurgeryPain IntensityPostoperative AnalgesiaDexmedetomidineEsketamine

Keywords

Spinal surgeryPain intensityDexmedetomidineEsketaminePostoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • Incidence of moderate-to-severe pain within 72 hours after surgery

    Pain intensity will be assessed at 1 and 6 hours, and then twice daily (8:00-10:00, 18:00-20:00) until 72 hours after surgery, using the Numerical Rating Scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain) both at rest and with movement (e.g., bed turning, walking). NRS pain scores 1-3 points indicate mild pain, 4-6 points indicate moderate pain, and 7-10 points indicate severe pain.

    Up to 72 hours after surgery

Secondary Outcomes (2)

  • Incidence of delayed neurocognitive recovery at postoperative day 5

    Up to 5 days after surgery

  • Incidence of cardiovascular events within 30 days after surgery

    Up to 30 days after surgery

Other Outcomes (8)

  • Area under curve of pain intensity within 72 hours postoperatively

    Up to 72 hours after surgery

  • Consumption of sufentanil-equivalent dose within 72 hours postoperatively

    Up to 72 hours after surgery

  • Quality of recovery score at 24 and 72 hours postoperatively

    Up to 72 hours after surgery

  • +5 more other outcomes

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 sufentanil 1.25 ug/h) 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 (sufentanil 1.25 ug/h) background infusion, and used for up to 48 hours.

Drug: Placebo administration

Interventions

Combined dexmedetomidine-esketamine administrationDRUG

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 sufentanil 1.25 ug/h) background infusion, and used for up to 48 hours.

Also known as: Dexmedetomidine and esketamine
Combined dexmedetomidine-esketamine group
Placebo administrationDRUG

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 (sufentanil 1.25 ug/h) background infusion, and used for up to 48 hours.

Also known as: Placebo (normal saline)
Placebo group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Uncontrolled preoperative hypertension (ward systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg);
  • Severe bradycardia (heart rate \<= 50 bpm), sick sinus syndrome, atrioventricular block of grade II or higher without pacemaker implantation, a history of myocardial infarction within one year, or presence of rapid ventricular arrhythmia;
  • History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis, or prresence of intracranial hypertension;
  • Uncontrolled hyperthyroidism or pheochromocytoma;
  • Inability to communicate due to coma, severe dementia, or language barrier;
  • Severe cardiac insufficiency (preoperative left ventricular ejection fraction \< 30% or New York Heart Association Functional classification IV), severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (preoperative dialysis), or American Society of Anesthesiologists physical status \>= IV;
  • Other conditions that are considered unsuitable for study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

DexmedetomidineEsketamineSaline Solution

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Dong-Xin Wang

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Xin Wang, MD, PhD

CONTACT

01083572784wangdongxin@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 4, 2026

First Posted

April 13, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)