Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery

Sleep Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06451627
• Other study ID #: esketamine-JMY
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Dyssomnias
• Esketamine
• Parasomnias
• Sleep Disturbance
• Spinal Surgery

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