Effect of esketamine on sleep disturbances after spinal surgery
Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery：A Randomized Controlled Trial
This study is testing if giving esketamine during spinal surgery can help patients sleep better and recover more smoothly afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06451627 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of intraoperative esketamine infusion on postoperative sleep disturbances in patients undergoing spinal surgery. Participants will receive either esketamine or saline during their surgery, and the study will assess various outcomes including sleep quality, pain levels, anxiety, and depression postoperatively. The trial aims to determine if esketamine can improve sleep disturbances and overall recovery in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 scheduled for elective spinal surgery under general anesthesia with an ASA classification of I to III.
Not a fit: Patients with a BMI over 35, severe organ lesions, or those requiring ICU admission post-surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative recovery and sleep quality for patients undergoing spinal surgery.
How similar studies have performed: While the specific use of esketamine in this context may be novel, similar studies have shown promising results in using ketamine for pain and sleep disturbances.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-65 years old, * American Society of Anesthesiologist (ASA) Physical Status classification I to III ; * Patients scheduled to undergo elective spinal surgery under general anesthesia; * Signed informed consent ; Exclusion Criteria: * BMI \> 35kg / m2 ; * Severe lesions of important organs and systems ; * The estimated duration of surgery is more than 4 hours * Patients who were 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.
Where this trial is running
Beijing
- Beijing Tian Tan Hospital — Beijing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.