Different Dose Esketamine and Dexmedetomidine for Supplemental Analgesia and Longterm Outcomes

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University First Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Esketamine

    Drug

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

Treatment groups

312 Participants
are divided into 3 treatment groups
Group A: Low-dose groupActive comparator 1 intervention
Group B: medium-dose groupExperimental treatment 1 intervention
Group C: High-dose groupExperimental treatment 1 intervention

Trial outcomes

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).

Time frame
At 3 months after surgery.

Secondary outcomes

1

Incidence of chronic postsurgical pain at 6 or 12 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).

Time frame
At 6 or 12 months after surgery.
2

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

Severity of chronic pain is assessed with the Brief Pain Inventory (BPI). The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40.

Time frame
At 3, 6, and 12 months after surgery.
3

Proportion of chronic analgesic use after surgery.

Chronic analgesic use is defined as consecutive use of analgesics for more than 3 months.

Time frame
At 3, 6, and 12 months after surgery.
4

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

Subjective sleep quality is assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a 7-item questionnaire consisting 19 self-rated questions that assesses sleep quality over the last month, each weighted equally on a 0-3 scale; higher scores indicate worse sleep quality.

Time frame
At 3, 6, and 12 months after surgery.

Other outcomes

Sponsors and contacts

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