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

NCT05456230 | Completed

• 1 other identifier: PLAGH-POD-001
• Study Type: observational
• Target: 11,927
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• the incidence of survival rate

  1 year

Study Arms (2)

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

Non-Midazolam

Midazolam was not given during the operation.

Interventions

Midazolam DRUG

Midazolam as a premedication was given as the patient is taken to the operating room and typically within 15 minutes of anesthetic induction.

Also known as: benzodiazepines

Midazolam

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hospital based group

You may qualify if:

• Geriatric surgical patients ≥65 years old Underwent elective non-cardiac surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Beijing Tiantan Hospital: collaborator
• Peking University First Hospital: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Xiangya Hospital of Central South University: collaborator
• Beijing Anzhen Hospital: collaborator
• China-Japan Friendship Hospital: collaborator
• Fudan University: collaborator
• Central South University: collaborator
• Peking University People's Hospital: collaborator
• Zhejiang University: collaborator
• Sun Yat-sen University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Taihe Hospital: collaborator
• The Affiliated Hospital Of Guizhou Medical University: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Zhejiang Provincial People's Hospital: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Midazolam; Benzodiazepines

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Weidong Mi, PhD

  Chinese PLA General Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 13, 2022
• Study Start: April 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: July 11, 2022
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)