Anxiety, Delirium
Conditions
Keywords
midazolam, delirium, anxiety
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.
Interventions
DRUGMidazolam
The intervention group patients were given 2mg midazolam injection (Jiangsu Enhua Pharmaceutical Co., Ltd.) during anesthesia induction
DRUGSaline
The control group patients were given 2 mL physiological saline.
Sponsors
Chinese PLA General Hospital
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 design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
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. BMI≤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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Intraoperative awareness of the occurrence | Surgery End | Intraoperative awareness of the occurrence |
| Incidence of postoeprative nausea and vomiting | Postoperative 1-7 | Incidence of postoeprative nausea and vomiting |
| Incidence of delayed extubation | Surgery End | Incidence of delayed extubation |
| 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 |
| 1-Year mortlity | Postoperative 1 year | 1-Year mortlity |
Countries
China
Outcome results
None listed