Impact of Intraoperative Midazolam on Delirium Outcome of Elderly Patients (I-IMODE): a Multicentre Randomised Controlled Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 612
- Locations
- 5
- Primary Endpoint
- Incidence of postoeprative delirium
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to 85 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •65 ≤ Age ≤ 85 years old;
- •Elective surgery under general anesthesia, with an estimated surgery time of ≥ 2 hours;
- •Non cardiac surgery, non neurosurgical surgery;
- •ASA grades I-III;
- •Agree to participate and sign the informed consent form;
Exclusion Criteria
- •Preoperative history of comorbidities such as depression and schizophrenia;
- •History of neurological disorders, moderate stroke;
- •Long term use of benzodiazepines before surgery;
- •BMI≤18.5/BMI≥30 kg/m2
- •There is cognitive impairment, which is determined based on Mini Mental State Examination (MMSE) scores below the standard threshold;
- •There are communication barriers, such as severe dementia, language barriers, and severe hearing or visual impairments;
- •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);
- •Preoperative severe liver and kidney dysfunction;
- •Patients expected to enter the ICU after surgery;
Arms & Interventions
Saline group
The control group patients were given 2 mL physiological saline during anesthesia induction.
Intervention: Saline (Drug)
Midazolam group
The intervention group patients were given 2mg midazolam injection (Jiangsu Enhua Pharmaceutical Co., Ltd.) during anesthesia induction
Intervention: Midazolam (Drug)
Outcomes
Primary Outcomes
Incidence of postoeprative delirium
Time Frame: Postoperaitve Day 1-7
Confusion Assessment Method (CAM) to assess the incidence of postoperative delirium, including four features: acute change or fluctuation course of mental status; inattention; altered level of consciousness; disorganized thinking
Incidence of postoperative anxiety
Time Frame: Postoperaitve Day 1-7
Generalized Anxiety disorder-7 (GAD-7) scale to assess the incidence of postoperative anxiety, with range from 0 to 21 scores, higher scores indicating more anxious.
Secondary Outcomes
- Intraoperative awareness of the occurrence(Surgery End)
- Incidence of delayed extubation(Surgery End)
- 1-Year mortlity(Postoperative 1 year)
- Onset time of delirium episodes(Postoperative Day 1-7)
- Frequency of delirium episodes(Postoperative Day 1-7)
- Subtype of delirium episodes(Postoperative Day 1-7)
- Anxiety severity(Postoperative Day 1-7)
- Resting and movement pain scores(Postoperative Day 1-3)
- Incidence of postoeprative nausea and vomiting(Postoperative 1-7)
- Incidence of non delirium complications and all-cause mortality(Postoperative Day 1-30)
- Length of hospital stay(Postoperative Day 1-30)
Investigators
Hao Li
Professor
Chinese PLA General Hospital