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

Completed

• Conditions: Postoperative Delirium
• Interventions: Drug: Midazolam

• Registration Number: NCT05456230
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Study Start: 2020-04-01
• Primary Completion: 2022-04-30
• Status Verified: 2022-07
• Study Completion: 2022-07-11
• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-11
• Study First Posted: 2022-07-13
• Last Update Submitted: 2022-07-14
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11927

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative delirium	Day 7 postoperatively	Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily

Secondary Outcome Measures

Name	Time	Method
the incidence of survival rate	1 year	collection of clinical data in the medical record and follow-up update

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China