Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery：A Randomized Controlled Trial

esketamine-JMY

The goal of this clinical trial is to learn about the effect of intraoperative esketamine infusion on postoperative sleep disturbance(PSD) of patients undergoing spinal surgery. The main aims to answer are: * To explore the effect of intraoperative infusion of esketamine on the incidence of postoperative sleep disturbance and sleep quality in patients undergoing spinal surgery. * To explore the effect of intraoperative infusion of esketamine on postoperative pain, anxiety and depression ; Participants will be patients undergoing spinal surgery with general anesthesia at Beijing Tiantan Hospital. 0.3mg/kg/h esketamine or saline will be infused during surgery . The incidence of sleep disturbance , sleep quality, pain scores, hospital anxiety and depression scores and perioperative adverse events after surgery will be investigated.

2024-06-10

2025-12-28

2026-01-28

Not yet recruiting

156

Inclusion Criteria: * 18-65 years old, * American Society of Anesthesiologist (ASA) Physical Status classification I to III ; * Scheduled to undergo elective spinal surgery under general anesthesia ; * Signed informed consent ; Exclusion Criteria: * BMI \> 35kg / m2 ; * Severe lesions of important organs and systems ; * Retained tracheal intubation or admitted to intensive care unit (ICU) postoperatively. * History of adverse reactions or contraindications to ketamine and esketamine ; * Cognitive dysfunction, communication disorders ; * Refused to participate in this study.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 156, 'type': 'ESTIMATED'}}

2024-06-11