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NCT Number: NCT06963112

Intraoperative Midazolam on Delirium Outcome of Elderly Patients

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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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliate Hospital of Guangxi Medical University, Guangxi, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

midazolam

Drug

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

Saline

Drug

The control group patients were given 2 mL physiological saline.

Primary outcomes

  1. 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

  2. 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

  1. Onset time of delirium episodes

    Time frame: Postoperative Day 1-7

    Onset time of delirium episodes

  2. Frequency of delirium episodes

    Time frame: Postoperative Day 1-7

    Frequency of delirium episodes

  3. Subtype of delirium episodes

    Time frame: Postoperative Day 1-7

    Subtype of delirium episodes

  4. Anxiety severity

    Time frame: 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.

  5. Resting and movement pain scores

    Time frame: Postoperative Day 1-3

    Resting and movement pain scores using NRS scale, with the range of 0-10, higher scores indicate more pain.

  6. Intraoperative awareness of the occurrence

    Time frame: Surgery End

    Intraoperative awareness of the occurrence

  7. Incidence of postoeprative nausea and vomiting

    Time frame: Postoperative 1-7

    Incidence of postoeprative nausea and vomiting

  8. Incidence of delayed extubation

    Time frame: Surgery End

    Incidence of delayed extubation

  9. Incidence of non delirium complications and all-cause mortality

    Time frame: Postoperative Day 1-30

    Incidence of non delirium complications and all-cause mortality

  10. Length of hospital stay

    Time frame: Postoperative Day 1-30

    Length of hospital stay

  11. 1-Year mortlity

    Time frame: Postoperative 1 year

    1-Year mortlity

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Changhai Hospital
  • China-Japan Union Hospital, Jilin University
  • First Affiliated Hospital of Guangxi Medical University
  • Second Hospital of Jilin University
  • The First Affiliated Hospital of Nanchang University

Registry information

Official study title

Impact of Intraoperative Midazolam on Delirium Outcome of Elderly Patients (I-IMODE): a Multicentre Randomised Controlled Trial

Acronym: IMODE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 8, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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