RecruitingN/Aketamine

Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery

Sponsored by Beijing Tiantan Hospital

NCT ID
NCT06451627
Target Enrollment
156 participants
Start Date
2024-06-10
Est. Completion
2026-01-28

About This Study

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 Studied

EsketamineSleep DisturbanceSpinal Surgery

Interventions

  • Esketamine
  • saline

Eligibility

Age:18 Years - 65 Years
Healthy Volunteers:No
View full eligibility 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.

Study Locations (1)

Beijing Tian Tan Hospital
Beijing, China

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

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