midazolam
DrugThe intervention group patients were given 2mg midazolam injection (Jiangsu Enhua Pharmaceutical Co., Ltd.) during anesthesia induction
NCT Number: NCT06963112
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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Notify Me65 year–85 year
All sexes
Interventional
Phase 1
The First Affiliate Hospital of Guangxi Medical University, Guangxi, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention group patients were given 2mg midazolam injection (Jiangsu Enhua Pharmaceutical Co., Ltd.) during anesthesia induction
The control group patients were given 2 mL physiological saline.
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
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.
Time frame: Postoperative Day 1-7
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
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.
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.
Time frame: Surgery End
Intraoperative awareness of the occurrence
Time frame: Postoperative 1-7
Incidence of postoeprative nausea and vomiting
Time frame: Surgery End
Incidence of delayed extubation
Time frame: Postoperative Day 1-30
Incidence of non delirium complications and all-cause mortality
Time frame: Postoperative Day 1-30
Length of hospital stay
Time frame: Postoperative 1 year
1-Year mortlity
Chinese PLA General Hospital
Other
Impact of Intraoperative Midazolam on Delirium Outcome of Elderly Patients (I-IMODE): a Multicentre Randomised Controlled Trial
Acronym: IMODE
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