Actively Recruiting
Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery
Led by Beijing Tiantan Hospital · Updated on 2025-01-24
156
Participants Needed
1
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 65 years old
- American Society of Anesthesiologist (ASA) Physical Status classification I to III
- Scheduled for elective spinal surgery under general anesthesia
- Signed informed consent form
You will not qualify if you...
- Body mass index over 35 kg/m2
- Severe lesions of important organs or systems
- Estimated surgery duration longer than 4 hours
- Postoperative tracheal intubation or admission to intensive care unit (ICU)
- History of adverse reactions or contraindications to ketamine or esketamine
- Cognitive dysfunction or communication disorders
- Refusal to participate in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tian Tan Hospital
Beijing, China, 100070
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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