Intraoperative Midazolam on Delirium Outcome of Elderly Patients

Launched by CHINESE PLA GENERAL HOSPITAL · May 6, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how a medication called midazolam might affect the development of delirium in older adults after surgery. Delirium is a condition that can cause confusion and changes in mental state, which can be especially concerning for elderly patients. In this study, researchers will compare two groups of patients: one group will receive low doses of midazolam to help with anesthesia, and the other group will receive a placebo (a treatment that looks the same but has no active ingredients). The goal is to see if midazolam helps reduce the incidence of delirium in patients aged 65 to 85 who are undergoing elective surgeries that last at least two hours.

To be eligible for this trial, patients must be between 65 and 85 years old and scheduled for certain types of non-cardiac, non-neurosurgical surgeries. They should also be generally healthy enough to undergo surgery, with no severe mental health issues or cognitive impairments. Participants will need to agree to take part in the study and sign a consent form. It's important to note that the trial is not yet recruiting participants, so there may be a wait before enrollment begins. Overall, this study aims to provide valuable insights on how midazolam can be safely used in older surgical patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 65 ≤ Age ≤ 85 years old;
• • 2. Elective surgery under general anesthesia, with an estimated surgery time of ≥ 2 hours;
• • 3. Non cardiac surgery, non neurosurgical surgery;
• • 4. ASA grades I-III;
• • 5. Agree to participate and sign the informed consent form;
• Exclusion Criteria:
• • 1. Preoperative history of comorbidities such as depression and schizophrenia;
• • 2. History of neurological disorders, moderate stroke;
• • 3. Long term use of benzodiazepines before surgery;
• • 4. 18.5≤BMI≤30 kg/m2
• • 5. There is cognitive impairment, which is determined based on Mini Mental State Examination (MMSE) scores below the standard threshold;
• • 6. There are communication barriers, such as severe dementia, language barriers, and severe hearing or visual impairments;
• • 7. There are any contraindications for the use of midazolam (contraindications for patients with severe respiratory dysfunction, patients with severe liver and kidney damage, patients with sleep apnea syndrome, and patients known to be allergic to benzodiazepines);
• • 8. Preoperative severe liver and kidney dysfunction;
• • 9. Patients expected to enter the ICU after surgery;