Postoperative Delirium (POD), Postoperative Sleep Disturbance
Conditions
Keywords
esketamine, non-cardiac surgery, Postoperative Delirium (POD), Postoperative Sleep Disturbance
Brief summary
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.
Interventions
DRUGEsketamine
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.
DRUG0.9 % saline
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.
Sponsors
Shanghai Chest Hospital
Shanghai Xuhui Central Hospital
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Drug: Esketamine After anesthesia induction intubation and before surgery,0.25mg/kg esketamine will be diluted into a 10ml syringe and injected intravenously. After surgery,a postoperative intravenous analgesia pump will be given with the following drugs and dosages:sufentanil 1.5ug/kg,esketaminge 1.0mg/kg and tolansetron 5mg, diluted into100ml at 2ml/h for 48h. Drug: 0.9% saline After anesthesia induction intubation and before surgery,10ml of 0.9% saline will be injected intravenously. After surgery,a postoperative intravenous analgesia pump will be given with the following drugs and dosages:sufentanil 1.5ug/kg and tolansetron 5mg, diluted into100ml at 2ml/h for 48h.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≧ 65 years; 2. ASA Ⅰ-Ⅲ; 3. Elective major non-cardiac surgery; 4. Voluntary signed informed consent.
Exclusion criteria
1. People with mental illness; 2. Suffering from serious central nervous system disorders such as arkinson's disease, Alzheimer's disease, etc; 3. Elevated intracranial pressure; 4. Emergency or trauma surgery; 5. Prior history of postoperative delirium or postoperative cognitive decline; 6. The patient has impaired hearing or impaired vision; 7. Suffering from severe systemic underlying diseases (e.g. cardiac insufficiency, malignant arrhythmia, malignant hypertension, hepatic failure, renal failure, etc.); 8. The patient is in chronic pain; 9. The patient is severely malnourished; 10. Patients with stage 3 or 4 malignant tumors, pancreatic cancer, allbladder cancer, cholangiocarcinoma and other tumors with high malignancy and poor prognosis. 11. history of allergy to or contraindication to esketamine; 12. inability or unwillingness to complete questionnaires or clinical testing; 13. Unable or unwilling to use a postoperative intravenous analgesic pump.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of postoperative delirium | postoperative 7 day | 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. |
| The incidence of postoperative sleep disturbance | postoperative 3 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of postoperative cognitive dysfunction | 7 days after surgery and 90 days after surgery | 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. |
| postoperative pain severity score | 2 hours after surgery、postoperative 3 day and 90 days after surgery | 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. |
| The incidence of postoperative adverse reactions | postoperative 90 days | 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.). |
Countries
China
Outcome results
None listed