Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery
- Conditions
- EsketamineSpinal SurgerySleep Disturbance
- Interventions
- Drug: saline
- Registration Number
- NCT06451627
- Lead Sponsor
- Beijing Tiantan Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 156
- 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 ;
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description saline 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 . esketamine 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 .
- Primary Outcome Measures
Name Time Method The incidence of postoperative sleep disturbance(PSD) in patients undergoing spinal surgery during the first three days after 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.
- Secondary Outcome Measures
Name Time Method 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 It will be evaluated by an sleep monitoring equipment which can record total sleep time in hour.
dosage of analgesics within 72 hours after surgery The analgesic consumption(PCIA) and supplemental analgesics within 72h will be recorded.
Postoperative hospital anxiety and depression scale ( HADS ) score. on the postoperative day 1 and postoperative day 3 after surgery 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.
The pain scores within 72hours after surgery 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.
Trial Locations
- Locations (1)
Beijing Tian Tan Hospital
🇨🇳Beijing, China