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

Postoperative Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05456230
• Other study ID #: PLAGH-POD-001
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: July 11, 2022

Study information

• Verified date: July 2022
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11927
• Est. completion date: July 11, 2022
• Est. primary completion date: April 30, 2022
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (18)

Lead Sponsor

Collaborator

Chinese PLA General Hospital

Beijing Anzhen Hospital, Beijing Tiantan Hospital, Central South University, China-Japan Friendship Hospital, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Xinjiang Medical University, Fudan University, Peking University First Hospital, Peking University People's Hospital, Sun Yat-sen University, Taihe Hospital, The Affiliated Hospital Of Guizhou Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Wuhan Union Hospital, China, Xiangya Hospital of Central South University, Zhejiang Provincial People's Hospital, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative delirium	Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily	Day 1 postoperatively
Primary	Incidence of postoperative delirium	Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily	Day 2 postoperatively
Primary	Incidence of postoperative delirium	Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily	Day 3 postoperatively
Primary	Incidence of postoperative delirium	Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily	Day 4 postoperatively
Primary	Incidence of postoperative delirium	Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily	Day 5 postoperatively
Primary	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	the incidence of survival rate	collection of clinical data in the medical record and follow-up update	1 year