Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Location status: Recruiting
NCT Number: NCT07002723
1. Eligible patients are randomly divided into experimental and control groups; 2. The experimental group is given esketamine combined with dexmedetomidine,while the control group is given normal saline; 3. The patients' sleep, pain, and cognition are followed up after surgery.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Shenzhen, Guangdong, China
Location status: Recruiting
One day before surgery, the investigators collect baseline data from patients at the bedside. Preoperative sleep quality is assessed using Pittsburgh sleep quality index(PSQI); Three-Minute Confusion Assessment Method(3D-CAM)is used to assess the incidence of delirium; cognitive function is assessed using Montreal Cognitive Assessment(MoCA); The Hospital Anxiety and Depression Scale (HADS) is used to assess patients' mood; Wong-Baker faces pain scale revision(FPS-R) and Numeric Rating Scale(NRS) are used to assess the patient's pain score at rest and during activity, and laboratory tests (Hb, Alb, K, NA, Cr, Alb, e-GFR) are recorded.
On the day of surgery, after successful neuraxial anesthesia, in the experimental group ,0.125mg/kg esketamine and 0.3ug/kg dexmedetomidine are diluted into 30ml of normal saline and continuously pumped for 20 minutes, followed by a micropump: 15ug/kg/h esketamine 0.02ug/kg/h dexmedetomidine to 96ml saline, continuous amount: 2ml/h, continuous pumping for 48h. Morphine 1 mg is given epidural at the beginning of surgery;while in the control group, same amount of normal saline is given. The patients are followed up for sleep quality, pain and delirium incidence after surgery. Long-term telephone follow-up of patients are focused on their cognitive function and recovery quality.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After successful neuraxial anesthesia, 0.125mg/kg esketamine and 0.3ug/kg dexmedetomidine are diluted into 30ml of normal saline and continuously pumped for 20 minutes, then connected to a micropump: 15ug/kg/h esketamine 0.02ug/kg/h dexmedetomidine to 96ml saline, continuous amount: 2ml/h, continuous pumping for 48h.
After successful neuraxial anesthesia, 30ml of normal saline was continuously pumped for 20 minutes, followed by a micropump: 96ml of saline, continuous amount: 2ml/h for 48h.
Time frame: the first postoperative night
Richards-Campbell sleep questionnaire (RCSQ) score is used to assess the sleep quality, the total score is 100 point, the lowest score is 0 point, and the highest score is 100 point, with higher scores representing better sleep quality.
Time frame: the second postoperative night, third postoperative night
Richards-Campbell sleep questionnaire (RCSQ) score is used to assess the sleep quality, the total score is 100 point, the lowest score is 0 point, and the highest score is 100 point, with higher scores representing better sleep quality.
Time frame: from the first to the fifth postoperative day
Incidence of delirium
Time frame: from the first day to the fifth postoperative day
Wong-Baker facial expression pain scale revision (FPS-R) at rest and during activity, the lowest score is 0 point, and the highest score is 10 points, with higher scores indicating more severe pain.
Time frame: from the first day to the fifth postoperative day
Numeric Rating Scale (NRS) at rest and during activity, the total score is 10 points, the lowest score is 0 point, and the highest score is 10 points, with higher scores indicating more severe pain.
Time frame: from the first day to the fifth postoperative day
Additional consumption of analgesic drugs
Time frame: perioperatively
Postoperative complications during hospitalization: pulmonary infection, myocardial infarction, renal failure, gastrointestinal bleeding, hypotension, bradycardia, dizziness, nausea, vomiting, nightmares and other psychiatric symptoms
Time frame: one month after surgery
Cognitive function : Montreal Cognitive Assessment (t-MoCA) score of the telephone version, the total score is 22 points, with a minimum of 0 point and a maximum of 22 points, with higher scores, the cognitive function is better.
Time frame: one month after surgery
Mortality rate
Time frame: one month after surgery
complications
Contact information is provided by the study sponsor or research team.
Peking University Shenzhen Hospital
Other
Effects of Esketamine Combined With Dexmedetomidine on Postoperative Sleep Quality in Elderly Patients Undergoing Hip Surgery:A Superiority Randomized Controlled Trail
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