Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06451627

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

Led by Beijing Tiantan Hospital · Updated on 2025-01-24

156

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate how intraoperative esketamine infusion affects postoperative sleep disturbance (PSD) in patients undergoing spinal surgery. It specifically investigates whether esketamine can influence the incidence of PSD, sleep quality, pain, anxiety, and depression after surgery. The study involves adult patients aged 18 to 65 scheduled for elective spinal surgery under general anesthesia at Beijing Tiantan Hospital. Participants are randomly assigned to receive either esketamine or saline infusion during spinal surgery. Esketamine is given at a dose of 0.3 mg/kg/h dissolved in normal saline, infused throughout the surgery. Both groups receive total intravenous anesthesia maintained with propofol and remifentanil, guided by the bispectral index to keep anesthesia depth between 40 and 60. The study is double-blind, meaning neither participants nor researchers know which infusion is given. During the study, researchers will monitor the incidence of postoperative sleep disturbance within the first three days after surgery. They will also assess sleep quality using sleep monitoring equipment on postoperative days 1 and 3, measure pain scores and analgesic use within 72 hours, and evaluate anxiety and depression levels using the hospital anxiety and depression scale. Adverse events and safety will be tracked throughout. Participation lasts through these early postoperative days with careful monitoring of sleep and recovery.

CONDITIONS

Brief Title

Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 to 65 years old
  • American Society of Anesthesiologist (ASA) Physical Status classification I to III
  • Scheduled for elective spinal surgery under general anesthesia
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) greater than 35 kg/m2
  • Severe lesions of important organs and systems
  • Estimated surgery duration longer than 4 hours
  • Postoperative tracheal intubation or admission to intensive care unit (ICU)
  • History of adverse reactions or contraindications to ketamine and esketamine
  • Cognitive dysfunction or communication disorders
  • Refusal to participate in the study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - During surgery

Participants receive esketamine or saline infusion during spinal surgery under general anesthesia.

1 visit (in-person)

Post-operative Follow-up

Duration - 3 days after surgery

Participants are monitored for sleep disturbance, pain, analgesic use, and anxiety and depression scores after surgery.

Assessments on postoperative day 1 and postoperative day 3

Trial Site Locations

Total: 1 location

1

Beijing Tian Tan Hospital

Beijing, China, 100070

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Effect of esketamine on postoperative sleep disturbance in patients undergoing spinal surgery: a study protocol for a randomised, double-blinded, placebo-controlled clinical trial.

Minyu Jian, Yiwei Chen, Shuo Wang...

https://pubmed.ncbi.nlm.nih.gov/40037679