Intraoperative Midazolam on Delirium Outcome of Elderly Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

612 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Delirium Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Saline group

The control group patients were given 2 mL physiological saline during anesthesia induction.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

The control group patients were given 2 mL physiological saline.

Midazolam group

The intervention group patients were given 2mg midazolam injection (Jiangsu Enhua Pharmaceutical Co., Ltd.) during anesthesia induction

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

The intervention group patients were given 2mg midazolam injection (Jiangsu Enhua Pharmaceutical Co., Ltd.) during anesthesia induction

Interventions

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Midazolam

The intervention group patients were given 2mg midazolam injection (Jiangsu Enhua Pharmaceutical Co., Ltd.) during anesthesia induction

Intervention Type DRUG

Saline

The control group patients were given 2 mL physiological saline.

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No