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New treatment option for Delirium
Official title Intraoperative Midazolam on Delirium Outcome of Elderly Patients
ClinicalTrials.gov ID: NCT06963112
What this study is testing
What is Midazolam?
Midazolam is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for delirium.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 85
You may be able to join if
- 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;
You likely can't join if
- Preoperative history of comorbidities such as depression and schizophrenia;
- History of neurological disorders, moderate stroke;
- Long term use of benzodiazepines before surgery;
- 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;
See the full eligibility 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;
- Preoperative history of comorbidities such as depression and schizophrenia;
- History of neurological disorders, moderate stroke;
- Long term use of benzodiazepines before surgery;
- 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...
- Preoperative severe liver and kidney dysfunction;
- Patients expected to enter the ICU after surgery;
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.