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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05456230
Enrollment
11927
Registered
2022-07-13
Start date
2020-04-01
Completion date
2022-07-11
Last updated
2022-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Delirium

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.

Interventions

DRUGMidazolam

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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of postoperative deliriumDay 1 postoperativelyOccurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily

Secondary

MeasureTime frameDescription
the incidence of survival rate1 yearcollection of clinical data in the medical record and follow-up update

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026