Dexmedetomidine Clinical Trial
Official title:
Effect of Mini-dose Esketamine-dexmedetomidine Supplemented Analgesia on Long-term Outcomes Following Scoliosis Correction Surgery: 2-year Follow-up of a Randomized Controlled Trial
Verified date | February 2023 |
Source | Peking University First Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Chronic postsurgical pain (CPSP) refers to pain that occurs or increases after surgery and lasts longer than 3 months. Severe postoperative acute pain is one of the major risk factors of CPSP. Spine surgery brings severe postoperative pain due to large trauma and long duration. Ketamine and esketamine are N-methyl-D-aspartate receptor antagonists; they have anti-hyperalgesic 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 the investigators, 200 patients following scoliosis correction surgery were randomzied to receive opioid analgsia supplemented with either mini-dose esketamine-dexmedetomidine combination or placebo. The results showed that esketamine-dexmedetomidine supplement analgesia significantly improved analgesia and sleep quality after surgery. This study is designed to test the hypothesis that mini-dose esketamine-dexmedetomidine supplemented analgesia may reduce CPSP at 2 years after scoliosis correction surgery.
Status | Active, not recruiting |
Enrollment | 199 |
Est. completion date | October 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients aged =18 years; - Scheduled for scoliosis correction surgery; - Required patient-controlled intravenous analgesia (PCIA) after surgery. Exclusion Criteria: - 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; - Obstructive sleep apnea syndrome, or a STOP-Bang score =3 in combination with a serum bicarbonate level =28 mmol/L; - Comorbid hyperthyroidism or pheochromocytoma; - History of schizophrenia, epilepsy, myasthenia gravis; - Preoperative delirium or communication barrier; - Severe liver dysfunction (Child-Pugh grade C), severe renal dysfunction (preoperative dialysis), or American Society of Anaesthesiologists grade =IV; - Body weight <40 kg; - Enrolled in other clinical studies; - Loss to follow-up; - Other conditions that were considered unsuitable for study participation. |
Country | Name | City | State |
---|---|---|---|
China | Peking University First Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
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Peking University First Hospital |
China,
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of chronic postsurgical pain at 2 years 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 2 years after surgery | |
Secondary | Severity of chronic pain at 2 years 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. | At 2 years after surgery | |
Secondary | Interference of chronic pain at 2 years after surgery | Interference 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 interference score corresponds to the item on pain interference. The seven subitems are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. | At 2 years after surgery | |
Secondary | Proportion of chronic analgesic use after surgery | Chronic analgesic use is defined as consecutive use of analgesics for more than 3 months. | Up to 2 years after surgery | |
Secondary | Proportion of analgesic use at 2 years after surgery | Proportion of analgesic use at 2 years after surgery (consecutive use of analgesics for more than 1 week within 3 months). | At 2 years after surgery | |
Secondary | Subjective sleep quality at 2 years after surgery | Subjective sleep quality at 2 years is assessed with the Pittsburgh Sleep Quality Index (PSQI). 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. | At 2 years after surgery | |
Secondary | Depression severity at 2 years after surgery | Depression is assessed with the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 includes 9-item requiring responses of 0 (not at all) to 3 (nearly every day) to assess the occurrence of depressive symptoms over the last two weeks. It has 8 items on depressive symptoms and 1 focused on suicidal ideation. Total scores range from 0 to 27, with higher score indicating more severe symptoms. | At 2 years after surgery | |
Secondary | Quality of life at 2 years after surgery | Quality of life is assessed using the Scoliosis Research Society-22 (SRS-22) patient questionnaire, which consists of five domains: function, pain, mental health, self-image, and satisfaction with management. | At 2 years after surgery | |
Secondary | Event-free survival | Event indicates any condition that requires hospitalization and clinical treatment for unexpected reasons. | Up to 2 years after surgery |
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