DeliriumPhase 1IMODENCT06963112
Intraoperative Midazolam on Delirium Outcome of Elderly Patients
A Phase 1 study testing Midazolam and Saline in people with Delirium and Anxiety, run by Chinese PLA General Hospital at 5 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- What is being tested?
- Midazolam and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 612 participants
- Where
- 5 sitesChina
- Study dates
- 1 Sep 2025to 30 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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;
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Chinese PLA General Hospital
Beijing, 100853
The First Affiliate Hospital of Guangxi Medical University
Guangxi, Guangxi
China-Japan Union Hospital of Jilin University
Jilin City
The Second Norman Bethune Hospital of Jilin University
Jilin City
Changhai Hostpital of Navy Medical University
Shanghai
About this study
Official title: Impact of Intraoperative Midazolam on Delirium Outcome of Elderly Patients (I-IMODE): a Multicentre Randomised Controlled Trial
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.
Read the 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.
- Being tested
- Midazolam, Saline
- Keywords
- midazolam, delirium, anxiety
- Medical subject headings
- Delirium, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
The intervention group patients were given 2mg midazolam injection (Jiangsu Enhua Pharmaceutical Co., Ltd.) during anesthesia induction
SalineDrug
The control group patients were given 2 mL physiological saline.
| Study group | Role | What they receive |
|---|---|---|
| Saline group | Placebo comparator | The control group patients were given 2 mL physiological saline during anesthesia induction. Receives: Drug: Saline |
| Midazolam group | Experimental | The intervention group patients were given 2mg midazolam injection (Jiangsu Enhua Pharmaceutical Co., Ltd.) during anesthesia induction Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Postoperaitve Day 1-7
Secondary outcomes (11)
Onset time of delirium episodes
Onset time of delirium episodes
Measured: Postoperative Day 1-7
Frequency of delirium episodes
Frequency of delirium episodes
Measured: Postoperative Day 1-7
Subtype of delirium episodes
Subtype of delirium episodes
Measured: Postoperative Day 1-7
Anxiety severity
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.
Measured: Postoperative Day 1-7
Resting and movement pain scores
Resting and movement pain scores using NRS scale, with the range of 0-10, higher scores indicate more pain.
Measured: Postoperative Day 1-3
Intraoperative awareness of the occurrence
Intraoperative awareness of the occurrence
Measured: Surgery End
Incidence of postoeprative nausea and vomiting
Incidence of postoeprative nausea and vomiting
Measured: Postoperative 1-7
Incidence of delayed extubation
Incidence of delayed extubation
Measured: Surgery End
Incidence of non delirium complications and all-cause mortality
Incidence of non delirium complications and all-cause mortality
Measured: Postoperative Day 1-30
Length of hospital stay
Length of hospital stay
Measured: Postoperative Day 1-30
1-Year mortlity
1-Year mortlity
Measured: Postoperative 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 Sep 2025
- Primary completion22 May 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 612 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, China-Japan Union Hospital, Jilin University, The First Affiliated Hospital of Nanchang University, First Affiliated Hospital of Guangxi Medical University, Second Hospital of Jilin University
- Responsible party
- Principal investigator, Hao Li, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963112
- Sponsor's protocol ID
- PLAGH-IMODE
- Acronym
- IMODE
- Status last verified
- Sep 2026
- First submitted
- 9 Apr 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intraoperative Midazolam on Delirium Outcome of Elderly Patients (I-IMODE): a Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06963112
- Acronym / sponsor ID
- IMODE / PLAGH-IMODE
- Keywords
- midazolam, delirium, anxiety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 612 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Changhai Hospital, China-Japan Union Hospital, Jilin University, The First Affiliated Hospital of Nanchang University, First Affiliated Hospital of Guangxi Medical University, Second Hospital of Jilin University
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline group | Placebo comparator | Drug: SalineThe control group patients were given 2 mL physiological saline during anesthesia induction. |
| Midazolam group | Experimental | Drug: MidazolamThe intervention group patients were given 2mg midazolam injection (Jiangsu Enhua Pharmaceutical Co., Ltd.) during anesthesia induction |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamThe intervention group patients were given 2mg midazolam injection (Jiangsu Enhua Pharmaceutical Co., Ltd.) during anesthesia induction | Drug | Midazolam group |
| SalineThe control group patients were given 2 mL physiological saline. | Drug | Saline group |
Primary outcome
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.
11 secondary outcomes
Onset time of delirium episodes
Time frame: Postoperative Day 1-7
Frequency of delirium episodes
Time frame: Postoperative Day 1-7
Subtype of delirium episodes
Time frame: Postoperative Day 1-7
Anxiety severity
Time frame: Postoperative Day 1-7
Resting and movement pain scores
Time frame: Postoperative Day 1-3
Intraoperative awareness of the occurrence
Time frame: Surgery End
Incidence of postoeprative nausea and vomiting
Time frame: Postoperative 1-7
Incidence of delayed extubation
Time frame: Surgery End
Incidence of non delirium complications and all-cause mortality
Time frame: Postoperative Day 1-30
Length of hospital stay
Time frame: Postoperative Day 1-30
1-Year mortlity
Time frame: Postoperative 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Midazolam and Saline in people with Delirium and Anxiety, run by Chinese PLA General Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoeprative delirium (time frame: Postoperaitve Day 1-7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.