Comparison of Postoperative Delirium in Elders Anaesthetised With Midazolam and Without Midazolam

Study Overview
=================
Brief Summary
-----------------
This research project is an observational cohort study by prospective chart review of patients that underwent surgery in multi-centers, China, in the years 2020-2022. The purpose of this study is to compare the occurrence of postoperative delirium With Midazolam and Without Midazolam During Non-cardiac Surgery in Elders.

Detailed Description
-----------------
Post operative delirium will be diagnosed using the 3D- CAM(Confusion Assessment Method) which tests for four features with a series of questions. The features include 1) acute onset and fluctuating course,2) inattention,3) disorganized thinking and 4) altered level of consciousness. Diagnosis of delirium is made if features 1 and 2 and either 3 or 4 are present. The demographic data of the patients,type and site of surgery will be noted. Preoperative hemoglobin, serum electrolytes and blood urea will be recorded. The intraoperative factors like duration of surgery and anaesthesia,use of intravenous fluids ,blood loss, number blood units transfused and opioid use will be studied at the time of surgery. The time to emergence and extubation following the completion of surgery will be noted. The postoperative factors like postoperative pain, nausea and vomiting, fever,hemoglobin,serum electrolytes and blood urea will be noted. Preoperative and postoperative pain will be assessed using the numerical rating score on a scale of one to ten. The association of various preoperative,intraoperative and postoperative factors with POD will be determined.

Official Title
-----------------
Comparison of Postoperative Delirium in Elders Anaesthetised With Midazolam and Without Midazolam During Non-cardiac Surgery

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

Intervention / Treatment
-----------------
* Drug: Midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Geriatric surgical patients ≥65 years old Underwent elective non-cardiac surgery Exclusion Criteria: History of neuropsychiatric diseases including delirium, mental disorders, Parkinson, dementia, etc.; The operation was cancelled due to various reasons after the patient was enrolled; severe liver disease; severe renal dysfunction defined as either having creatinine clearance < 30 ml/min or being dialysis-dependent; Patients who undergo second operation in a short period; Refused to participate in the study.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Midazolam<br>Midazolam as a premedication was given as the patient is taken to the operating room and typically within 15 minutes of anesthetic induction. | Drug: Midazolam<br>* Midazolam as a premedication was given as the patient is taken to the operating room and typically within 15 minutes of anesthetic induction.<br>* Other names: benzodiazepines;|
| Non-Midazolam<br>Midazolam was not given during the operation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative delirium | Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily | Day 1 postoperatively | 
| Incidence of postoperative delirium | Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily | Day 2 postoperatively | 
| Incidence of postoperative delirium | Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily | Day 3 postoperatively | 
| Incidence of postoperative delirium | Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily | Day 4 postoperatively | 
| Incidence of postoperative delirium | Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily | Day 5 postoperatively | 
| Incidence of postoperative delirium | Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily | Day 7 postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of survival rate | collection of clinical data in the medical record and follow-up update | 1 year |