Comparison of Postoperative Delirium in Elders Anaesthetised With Midazolam and Without Midazolam
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Midazolam 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
Midazolam as a premedication was given as the patient is taken to the operating room and typically within 15 minutes of anesthetic induction.
Other Names:
|
| Non-Midazolam Midazolam was not given during the operation. |
Outcome Measures
Primary Outcome Measures
- Incidence of postoperative delirium [Day 1 postoperatively]
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
- Incidence of postoperative delirium [Day 2 postoperatively]
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
- Incidence of postoperative delirium [Day 3 postoperatively]
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
- Incidence of postoperative delirium [Day 4 postoperatively]
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
- Incidence of postoperative delirium [Day 5 postoperatively]
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
- Incidence of postoperative delirium [Day 7 postoperatively]
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
Secondary Outcome Measures
- the incidence of survival rate [1 year]
collection of clinical data in the medical record and follow-up update
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chinese PLA General Hospital | Beijing | Beijing | China | 100853 |
Sponsors and Collaborators
- Chinese PLA General Hospital
- Beijing Tiantan Hospital
- Peking University First Hospital
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Xiangya Hospital of Central South University
- Beijing Anzhen Hospital
- China-Japan Friendship Hospital
- Fudan University
- Central South University
- Peking University People's Hospital
- Zhejiang University
- Sun Yat-sen University
- Wuhan Union Hospital, China
- Taihe Hospital
- The Affiliated Hospital Of Guizhou Medical University
- First Affiliated Hospital of Xinjiang Medical University
- First Affiliated Hospital of Guangxi Medical University
- Zhejiang Provincial People's Hospital
Investigators
- Study Chair: Weidong Mi, PhD, Chinese PLA General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PLAGH-POD-001