Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-10

Study Completion Date

2026-01-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Esketamine Sleep Disturbance Spinal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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 .

Group Type EXPERIMENTAL

Esketamine

Intervention Type DRUG

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 .Total intravenous anesthesia with propofol ,remifentanil will be implemented for anesthesia maintenance based on the bispectral index(BIS) and keep BIS between 40-60 .

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

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

Interventions

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Esketamine

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

Intervention Type DRUG

saline

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No