Dexmedetomidine-esketamine Combination and Moderate-to-severe 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 improve analgesia and reduce moderate-to-severe pain in patients after spinal surgery.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
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