RecruitingNot ApplicableNCT06451627

Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery

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

Sponsor

Beijing Tiantan Hospital

Enrollment

156 participants

Start Date

Jun 10, 2024

Study Type

INTERVENTIONAL

Conditions

Sleep Disturbance Esketamine

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

-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 Criteria7

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.