Clinical trial NCT06963112: Intraoperative Midazolam on Delirium Outcome of Elderly Patients
Official title: Impact of Intraoperative Midazolam on Delirium Outcome of Elderly Patients (I-IMODE): a Multicentre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Delirium
Anxiety
Keywords: midazolam
delirium
anxiety
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Changhai hospital of Navy Medical University
name: China-Japan Union Hospital, Jilin University
name: The First Affiliated Hospital of Nanchang University
name: The First Affiliate Hospital of Guangxi Medical College
First posted: 2025-05-08
Enrollment: 612
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was a multicenter, randomized, double-blind, placebo-controlled trial to treat elderly surgical patients with low-dose midazolam or placebo for anesthesia induction. The incidence of postoperative 7-day delirium was assessed and compared between two groups, to provide valuable reference for clinical practitioners in the use of midazolam in elderly surgical patients.

Detailed description: This study is a multicenter, randomized, double-blind, placebo-controlled trial. A total elderly patients who underwent elective non cardiac surgery were included in the plan and randomly divided into an intervention group and a control group. The intervention group patients were given 2mg midazolam injection (Jiangsu Enhua Pharmaceutical Co., Ltd.) during anesthesia induction; The control group patients were given equal volume physiological saline. Follow up assessment of postoperative delirium and anxiety will be conducted 1-7 days after surgery, and cognitive function follow-up will be conducted 1 month after surgery.

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;

Primary outcomes:
measure: Incidence of postoeprative delirium
timeFrame: Postoperaitve Day 1-7
measure: Incidence of postoperative anxiety
timeFrame: Postoperaitve Day 1-7
Secondary outcomes:
measure: Onset time of delirium episodes
timeFrame: Postoperative Day 1-7
measure: Frequency of delirium episodes
timeFrame: Postoperative Day 1-7
measure: Subtype of delirium episodes
timeFrame: Postoperative Day 1-7
measure: Anxiety severity
timeFrame: Postoperative Day 1-7
measure: Resting and movement pain scores
timeFrame: Postoperative Day 1-3
measure: Intraoperative awareness of the occurrence
timeFrame: Surgery End
measure: Incidence of postoeprative nausea and vomiting
timeFrame: Postoperative 1-7
measure: Incidence of delayed extubation
timeFrame: Surgery End
measure: Incidence of non delirium complications and all-cause mortality
timeFrame: Postoperative Day 1-30
measure: Length of hospital stay
timeFrame: Postoperative Day 1-30
measure: 1-Year mortlity
timeFrame: Postoperative 1 year
Other outcomes:
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