Clinical trial NCT05456230: Comparison of Postoperative Delirium in Elders Anaesthetised With Midazolam and Without Midazolam
Official title: Comparison of Postoperative Delirium in Elders Anaesthetised With Midazolam and Without Midazolam During Non-cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Delirium
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Peking University First Hospital
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Xiangya Hospital of Central South University
name: Beijing Anzhen Hospital
name: China-Japan Friendship Hospital
name: Fudan University
name: Central South University
name: Peking University People's Hospital
name: Zhejiang University
name: Sun Yat-sen University
name: Wuhan Union Hospital, China
name: Taihe Hospital
name: The Affiliated Hospital Of Guizhou Medical University
name: First Affiliated Hospital of Xinjiang Medical University
name: First Affiliated Hospital of Guangxi Medical University
name: Zhejiang Provincial People's Hospital
First posted: 2022-07-13
Enrollment: 11927
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital based group

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.

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.

Primary outcomes:
measure: Incidence of postoperative delirium
timeFrame: Day 1 postoperatively
measure: Incidence of postoperative delirium
timeFrame: Day 2 postoperatively
measure: Incidence of postoperative delirium
timeFrame: Day 3 postoperatively
measure: Incidence of postoperative delirium
timeFrame: Day 4 postoperatively
measure: Incidence of postoperative delirium
timeFrame: Day 5 postoperatively
measure: Incidence of postoperative delirium
timeFrame: Day 7 postoperatively
Secondary outcomes:
measure: the incidence of survival rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Weidong Mi, PhD
role: STUDY_CHAIR
References: