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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium
• Intervention / Treatment: Drug: Midazolam

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 Type: Observational
• Enrollment (Actual): 11927

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

hospital based group

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Midazolam as a premedication was given as the patient is taken to the operating room and typically within 15 minutes of anesthetic induction.; Other Names: benzodiazepines
Non-Midazolam; Midazolam was not given during the operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of survival rate	collection of clinical data in the medical record and follow-up update	1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2020
• Primary Completion (ACTUAL): April 30, 2022
• Study Completion (ACTUAL): July 11, 2022

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (ACTUAL): July 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: PLAGH-POD-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No