Intraoperative Midazolam on Delirium Outcome of Elderly Patients

NCT06963112 | Recruiting Phase 1 DMC

• 1 other identifier: PLAGH-IMODE
• Study Type: interventional
• Target: 612
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Anxiety

Keywords

midazolam; delirium; anxiety

Outcome Measures

Primary Outcomes (2)

• Incidence of postoeprative delirium

  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

  Postoperaitve Day 1-7

• Incidence of postoperative anxiety

  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.

  Postoperaitve Day 1-7

Secondary Outcomes (11)

• 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

Study Arms (2)

Saline group

PLACEBO COMPARATOR

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

Drug: Saline

Midazolam group

EXPERIMENTAL

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

Drug: Midazolam

Interventions

Midazolam DRUG

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

Midazolam group

Saline DRUG

The control group patients were given 2 mL physiological saline.

Saline group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≤ 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;

You may not qualify if:

• Preoperative history of comorbidities such as depression and schizophrenia;
• History of neurological disorders, moderate stroke;
• Long term use of benzodiazepines before surgery;
• ≤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;

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Changhai hospital of Navy Medical University: collaborator
• China-Japan Union Hospital, Jilin University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• The First Affiliate Hospital of Guangxi Medical College: collaborator
• Second Hospital of Jilin University: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, 100853, China

RECRUITING

MeSH Terms

Conditions

Delirium; Anxiety Disorders

Interventions

Midazolam; Sodium Chloride

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: May 8, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)