Postoperative delirium (POD) is a common surgical complication.It is associated with a range of negative outcomes such as delayed postoperative recovery,prolonged hospitalization,additional medical expenditures and higher mortality. Meanwhile,sleep disorders are not only an important predisposing factor for delirium,but also one of the main symptoms of delirium.Systemic inflammatory responses caused by sleep disorders may be an important mechanism for POD. Many studies have shown that esketamie may inhibit inflammatory factors and enhance neuroplasticity. In summary,we felt the need to further explore the therapeutic potential of esketamine in the area of POD as well as postoperative sleep disorders.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
loading dose:intravenous infusion of 0.25mg/kg esketamine after induction of aneshtesia; postoperative intravenous analgesia:1.5ug/kg sufentail+1mg/kg esketamine diluted into 100ml will be provided to the patients after surgery at a rate of 2ml/h for 48h.
loading dose:intravenous infusion the same volume of 0.9% saline as the other group after induction of aneshtesia; postoperative intravenous analgesia:1.5ug/kg sufentail diluted into 100ml will be provided to the patients after surgery at a rate of 2ml/h for 48h.
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
The incidence of postoperative delirium
Postoperative delirium is assessed by the 3-minute diagnostic interview for CAM (3D-CAM) or the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) as applicable.
Time frame: postoperative 7 day
The incidence of postoperative sleep disturbance
Postoperative sleep disturbance is evaluated by the Athens Insomnia Scale (AIS). The AIS is a self-rated psychometric questionnaire to quantify sleep difficulties according to the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision criteria. The AIS consists of 8 items: waking up at night, sleep induction, final awakening, total sleep duration, sleep quality, well-being, functional ability, and daytime sleepiness. The AIS score ranges from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.
Time frame: postoperative 3 day
The incidence of postoperative cognitive dysfunction
Postoperative delirium is assessed by the Montreal Cognitive Assessment (MoCA). MoCA scale was widely identified in the detection of mild cognitive impairment. MoCA assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points; a score of 26 or above is considered normal.
Time frame: 7 days after surgery and 90 days after surgery
postoperative pain severity score
The degree of surgical incision pain will be assessed at rest and on movement by Visual Analogue Scale (VAS). VAS ranges from 0 to 10, with the highest score indicating the worst pain.
Time frame: 2 hours after surgery、postoperative 3 day and 90 days after surgery
The incidence of postoperative adverse reactions
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Postoperative adverse reactions within 90 days were defined as postoperative adverse reactions that are new, have an adverse effect on the patient, and require medical intervention (including psychiatric system symptoms, 30-day all-cause mortality etc.).
Time frame: postoperative 90 days