Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery

Capital Medical University

Status: Enrolling

Conditions: Spinal Surgery; Esketamine; Sleep Disturbance

Treatments: Drug: Esketamine; Drug: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06451627

esketamine-JMY

Details and patient eligibility

About

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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 2 patient groups, including a placebo group

esketamine

Experimental group

Description:

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 .

Treatment:

Drug: Esketamine

saline

Placebo Comparator group

Description:

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 .

Treatment:

Drug: saline