Skip to main content
OpenTrials
Completed

NCT Number: NCT05456230

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: benzodiazepines

Primary outcomes

  1. Incidence of postoperative delirium

    Time frame: Day 1 postoperatively

    Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily

  2. Incidence of postoperative delirium

    Time frame: Day 2 postoperatively

    Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily

  3. Incidence of postoperative delirium

    Time frame: Day 3 postoperatively

    Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily

  4. Incidence of postoperative delirium

    Time frame: Day 4 postoperatively

    Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily

  5. Incidence of postoperative delirium

    Time frame: Day 5 postoperatively

    Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily

  6. Incidence of postoperative delirium

    Time frame: Day 7 postoperatively

    Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily

Secondary outcomes

  1. the incidence of survival rate

    Time frame: 1 year

    collection of clinical data in the medical record and follow-up update

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 13, 2022
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.