Dexmedetomidine-esketamine Combination and Chronic Postsurgical Pain After Spinal Surgery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-80
SponsorPeking University First Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Combined dexmedetomidine-esketamine administration
- Placebo administration
Treatment groups
274 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov