Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery

NCT06451627 | Recruiting DMC

• 1 other identifier: esketamine-JMY
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esketamine; Sleep Disturbance; Spinal Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• objective sleep quality(total sleep time) of patients with spinal surgery assesssed by the sleep monitoring equipment.

  on the postoperative day 1 and postoperative day 3 after surgery

• The pain scores

  within 72hours after surgery

• dosage of analgesics

  within 72 hours after surgery

• Postoperative hospital anxiety and depression scale ( HADS ) score.

  on the postoperative day 1 and postoperative day 3 after surgery

Other Outcomes (1)

• The incidence of all drug-related adverse events

  within 72hours after surgery

Study Arms (2)

esketamine

EXPERIMENTAL

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

saline

PLACEBO COMPARATOR

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

Interventions

Esketamine DRUG

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

esketamine

saline DRUG

Saline will be infused at a speed of 0.3mg / kg / h during surgery .

saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tian Tan Hospital

Beijing, 100070, China

RECRUITING

Related Publications (1)

• Jian M, Chen Y, Wang S, Zhou Y, Liu H, Liang F, Han R, Wang H. Effect of esketamine on postoperative sleep disturbance in patients undergoing spinal surgery: a study protocol for a randomised, double-blinded, placebo-controlled clinical trial. BMJ Open. 2025 Mar 4;15(3):e090089. doi: 10.1136/bmjopen-2024-090089.

  PMID: 40037679 DERIVED

MeSH Terms

Conditions

Parasomnias

Interventions

Esketamine; Sodium Chloride

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: June 11, 2024
• Study Start: June 10, 2024
• Primary Completion: December 28, 2025
• Study Completion: January 28, 2026
• Last Updated: January 24, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Access Criteria: The data that support the findings of this study are available from the corresponding author, HW upon reasonable request.

Locations

CN (1)