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| Name | Class |
|---|---|
| Changhai hospital of Navy Medical University | UNKNOWN |
| China-Japan Union Hospital, Jilin University | OTHER |
| The First Affiliated Hospital of Nanchang University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline group | Placebo Comparator | The control group patients were given 2 mL physiological saline during anesthesia induction. |
|
| Midazolam group | Experimental | The intervention group patients were given 2mg midazolam injection (Jiangsu Enhua Pharmaceutical Co., Ltd.) during anesthesia induction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | The intervention group patients were given 2mg midazolam injection (Jiangsu Enhua Pharmaceutical Co., Ltd.) during anesthesia induction |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Onset time of delirium episodes | Onset time of delirium episodes | Postoperative Day 1-7 |
| Frequency of delirium episodes | Frequency of delirium episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | 100853 | China |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| First Affiliated Hospital of Guangxi Medical University |
| OTHER |
| Second Hospital of Jilin University | OTHER |
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| Saline | Drug | The control group patients were given 2 mL physiological saline. |
|
| Postoperative Day 1-7 |
| Subtype of delirium episodes | Subtype of delirium episodes | 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. | 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. | Postoperative Day 1-3 |
| Intraoperative awareness of the occurrence | Intraoperative awareness of the occurrence | Surgery End |
| Incidence of postoeprative nausea and vomiting | Incidence of postoeprative nausea and vomiting | Postoperative 1-7 |
| Incidence of delayed extubation | Incidence of delayed extubation | Surgery End |
| Incidence of non delirium complications and all-cause mortality | Incidence of non delirium complications and all-cause mortality | Postoperative Day 1-30 |
| Length of hospital stay | Length of hospital stay | Postoperative Day 1-30 |
| 1-Year mortlity | 1-Year mortlity | Postoperative 1 year |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |