Intraoperative Midazolam on Delirium Outcome of Elderly Patients

Phase 1

Not yet recruiting

• Conditions: Delirium; Anxiety
• Interventions: Drug: Saline; Drug: Midazolam

• Registration Number: NCT06963112
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-09
• Study Start: 2025-05-01
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Study First Posted: 2025-05-08
• Last Update Posted: 2025-05-08
• Primary Completion: 2026-07-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 612

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline group	Saline	The control group patients were given 2 mL physiological saline during anesthesia induction.
Midazolam group	Midazolam	The intervention group patients were given 2mg midazolam injection (Jiangsu Enhua Pharmaceutical Co., Ltd.) during anesthesia induction

Primary Outcome Measures

Name	Time	Method
Incidence of postoeprative delirium	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	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 Outcome Measures

Name	Time	Method
Intraoperative awareness of the occurrence	Surgery End	Intraoperative awareness of the occurrence
Incidence of delayed extubation	Surgery End	Incidence of delayed extubation
1-Year mortlity	Postoperative 1 year	1-Year mortlity
Onset time of delirium episodes	Postoperative Day 1-7	Onset time of delirium episodes
Frequency of delirium episodes	Postoperative Day 1-7	Frequency of delirium episodes
Subtype of delirium episodes	Postoperative Day 1-7	Subtype of delirium episodes
Anxiety severity	Postoperative Day 1-7	GAD-7 scale to assess anxiety severity: 0-4 scores indicating no anxiety, 5-9 scores indicating mild anxiety, 10-14 scores indicating moderate anxiety, ≥15 scores indicating severe anxiety.
Resting and movement pain scores	Postoperative Day 1-3	Resting and movement pain scores using NRS scale, with the range of 0-10, higher scores indicate more pain.
Incidence of postoeprative nausea and vomiting	Postoperative 1-7	Incidence of postoeprative nausea and vomiting
Incidence of non delirium complications and all-cause mortality	Postoperative Day 1-30	Incidence of non delirium complications and all-cause mortality
Length of hospital stay	Postoperative Day 1-30	Length of hospital stay