Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disturbance; Spinal Surgery; Esketamine
• Intervention / Treatment: Drug: Esketamine; Drug: saline

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100070
    • Recruiting
    • Beijing Tian tan Hospital
    • Contact: Ruquan Han, M.D., Ph.D; Phone Number: 8610-59976660; Email: ruquan.han@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: esketamine; Esketamine ( 50mg, dissolved in 50ml normal saline ) will be infused at a speed of 0.3mg / kg / h during surgery .Total intravenous anesthesia with propofol ,remifentanil will be implemented for anesthesia maintenance based on the bispectral index(BIS) and keep BIS between 40-60 .	Drug: Esketamine; Esketamine ( 50mg, dissolved in 50ml normal saline ) will be infused at a speed of 0.3mg / kg / h during surgery .
Placebo Comparator: saline; Saline will be infused at a speed of 0.3mg / kg / h during surgery .Total intravenous anesthesia with propofol ,remifentanil will be implemented for anesthesia maintenance based on the bispectral index(BIS) and keep BIS between 40-60 .	Drug: saline; Saline will be infused at a speed of 0.3mg / kg / h during surgery .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
dosage of analgesics	The analgesic consumption(PCIA) and supplemental analgesics within 72h will be recorded.	within 72 hours after surgery
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Estimated): December 28, 2025
• Study Completion (Estimated): January 28, 2026

Study Registration Dates

• First Submitted: May 11, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Dyssomnias; Parasomnias; Psychotropic Drugs; Antidepressive Agents; Esketamine
• Other Study ID Numbers: esketamine-JMY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data generated or analysed during this study will be included in published article. The data that support the findings of this study are available from the corresponding author, HW upon reasonable request.
• IPD Sharing Access Criteria: The data that support the findings of this study are available from the corresponding author, HW upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No