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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06451627
Other study ID # esketamine-JMY
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 10, 2024
Est. completion date January 28, 2026

Study information

Verified date June 2024
Source Beijing Tiantan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 156
Est. completion date January 28, 2026
Est. primary completion date December 28, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Intervention

Drug:
Esketamine
Esketamine ( 50mg, dissolved in 50ml normal saline ) will be infused at a speed of 0.3mg / kg / h during surgery .
saline
Saline will be infused at a speed of 0.3mg / kg / h during surgery .

Locations

Country Name City State
China Beijing Tian Tan Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other The incidence of all drug-related adverse events All drug-related adverse events including bradycardia, hypotension, tachycardia, hypertension, arrhythmia, nystagmus, hypersalivation, euphoria, emergence agitation, hallucinations, dreaminess and nightmares during surgery or before discharge.etc.Patients will be followed up for 3 days consecutively(at 8-10am). within 72hours after surgery
Primary The incidence of postoperative sleep disturbance(PSD) in patients undergoing spinal surgery It will be evaluated by Athens Insomnia Scale (AIS) on the morning(8-10 am) of postoperative days 1-3, a score of 6 or higher will be defined as PSD. during the first three days after surgery
Secondary objective sleep quality(total sleep time) of patients with spinal surgery assesssed by the sleep monitoring equipment. It will be evaluated by an sleep monitoring equipment which can record total sleep time in hour. on the postoperative day 1 and postoperative day 3 after surgery
Secondary The pain scores Postoperative pain at rest and movement will be evaluated on the morning(8-10 am) of postoperative days 1-3 using NRS.0 indicating no pain, 10 indicating worst pain imaginable. within 72hours after surgery
Secondary dosage of analgesics The analgesic consumption(PCIA) and supplemental analgesics within 72h will be recorded. within 72 hours after surgery
Secondary Postoperative hospital anxiety and depression scale ( HADS ) score. Postoperative anxiety and depression scores will be measured by the Hospital Anxiety and Depression Scale, on the morning(8-10 am) of postoperative days (PODs) 1 and 3 , a score of 8 points or higher will be diagnosed as depression or anxiety. on the postoperative day 1 and postoperative day 3 after surgery
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