Whether Opioids Are Factor That Induced POD?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate whether perioperative use of low doses of opioids could reduce postoperative delirium .

Detailed Description
-----------------
Postoperative delirium (POD) is a common postoperative complication of the elderly caused by a variety of factors. POD is an acute neuropsychiatric disorder characterized by disturbance of attention consciousness and cognitive function fluctuation, and more than 40% of elderly patients have symptoms of hypoactivity POD.The incidence of POD is as high as 17% to 61% in patients with neurocognitive impairment and patients undergoing complex or emergency surgery, which usually occurs between 1 and 3 days after surgery. POD will lead to prolonged hospital stay, functional impairment and even death. How to prevent and treat POD is an urgent clinical problem to be solved at present. Opiates are commonly used perioperative sedatives and analgesics, which may be associated with the occurrence of postoperative POD in elderly patients and increase the risk of POD. It is not clear whether perioperative use of low doses of opioids could reduces the incidence of POD in elderly patients. In this study, reducing-opioids anesthesia was defined as the use of 1/3 of the conventional opioid dose to observe whether reducing-opioids anesthesia affected the incidence of POD in elderly patients undergoing gastric cancer surgery

Official Title
-----------------
Whether Opioids Are Factor That Induced Postoperative Delirium?

Conditions
-----------------
Postoperative Delirium

Intervention / Treatment
-----------------
* Drug: Sufentanil Citrate
* Drug: Ropivacaine 0.75% Injectable Solution
* Procedure: Epidural catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients' age ≥65 years Underwent elective radical gastrectomy Exclusion Criteria: Mini-Mental Scale Test (MMSE) Exclusion criteria: illiteracy <18, primary school <21, junior school and above <25 Preoperative clear systems and spiritual history of neurological disease or long-term use of sedatives or antidepressants History of alcohol abuse or a history of drug dependence Have brain surgery or trauma Cannot with the completion of tests of Postoperative Cognitive Dysfunction Refused to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sufentanyl+Epidural analgesia<br>Combined use of sufentanil and ropivacaine for intraoperative and postoperative analgesia | Drug: Sufentanil Citrate<br>* Intraoperative loading dose of sufentanil 0.6μg/kg, each additional hour 10μg, within one hour of the end of surgery to stop additional.Postoperative analgesia pump formula: sufentanil 150ug + 0.75% ropivacaine 60ml with 0.9% saline diluted to 220ml, 3ml<br>* Other names: Sufentanil;Drug: Ropivacaine 0.75% Injectable Solution<br>* Intraoperative epidural analgesia was performed with 0.5% ropivacaine 5-20 ml,Postoperative analgesia pump formula:0.75% ropivacaine 60ml with 0.9% saline diluted to 220ml, 3ml/h, Blos 3ml, locking time 15min, the maximum dose of 36ml in 4 hours Saline is used to dilute other drugs<br>* Other names: Ropivacaine;Procedure: Epidural catheter<br>* Intraoperative and postoperative analgesia<br>|
| Sham Comparator: Epidural analgesia<br>Only use of ropivacaine for intraoperative and postoperative analgesia | Drug: Ropivacaine 0.75% Injectable Solution<br>* Intraoperative epidural analgesia was performed with 0.5% ropivacaine 5-20 ml,Postoperative analgesia pump formula:0.75% ropivacaine 60ml with 0.9% saline diluted to 220ml, 3ml/h, Blos 3ml, locking time 15min, the maximum dose of 36ml in 4 hours Saline is used to dilute other drugs<br>* Other names: Ropivacaine;Procedure: Epidural catheter<br>* Intraoperative and postoperative analgesia<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative delirium | confusion assessment method for the ICU(CAM-ICU) | 3 days after surgery | 
| Incidence of postoperative delirium | Richmond agitation and sedation scale(RASS), the RASS score was divided into 10 sedation scales, ranging from +4 to -5, representing the patient's degree from aggressive to unconscious, with each score corresponding to a state of consciousness. When the RASS score was ≥-3, the CAM-ICU assessment was performed. | 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale(VAS) | VAS is a scale of 11 numbers ranging from 0 to 10, with 0 representing no pain and 10 representing the most pain. Patients choose one of the 11 numbers to represent the pain level according to their own pain. 0: no pain; Less than 3 points: mild pain, tolerable; 4-6 points: the patient's pain and affect sleep, still tolerable; 7-10: Patients have increasing pain, pain is unbearable, affect appetite, affect sleep. | 3 days after surgery | 
| Anaesthesia related adverse event | Nausea and vomiting | 3 days after surgery | 
| blood pressure | Hypertension or hypotension was defined as an increase or decrease in mean arterial pressure of more than 30% at baseline | 3 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opioid, POD, gastric cancer