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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11927 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2022-07-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Midazolam

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

Midazolam

Intervention Type DRUG

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

Non-Midazolam

Midazolam was not given during the operation.

No interventions assigned to this group

Interventions

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Midazolam

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

Intervention Type DRUG

Other Intervention Names

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benzodiazepines

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No