Effect of different doses of Midazolam at night on the incidence of delirium in ICU patients: a single center, double-blind, randomized clinical trial

Effect of different doses of Midazolam at night on the incidence of delirium in ICU patients

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300073243

Enrollment

Unknown

Registered

2023-07-05

Start date

2023-07-05

Completion date

Unknown

Last updated

2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICU delirium

Interventions

experimental group 1:The patient's basic sedation at night was halved and the dose of Midazolam received was 0.01-0.03mg/kg/h, and the dose of Midazolam was adjusted within the given range according t

experimental group 2:The patient's basic sedation at night was halved and the dose of Midazolam received was 0.03-0.05mg/kg/h, and the dose of Midazolam was adjusted within the given range according t

experimental group 3:On the basis of basic sedation, the patient continued to pump saline of the same volume as Midazolam at night, and adjusted sedative drugs to achieve the same target sedation leve

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age=18 (2) Enter the ICU and receive intermittent or continuous sedation (3) Need ventilator support (4) BMI 18-30kg/m² (5) Expected ICU hospitalization time = 24 hours

Exclusion criteria

Exclusion criteria: (1) The patient already has delirium (2) Hospitalization due to primary neurological diseases or injuries (such as Traumatic brain injury, Intracranial hemorrhage, severe mental disability, etc.) may hinder the evaluation of delirium (3) History of severe dementia (4) Continuously unconscious person (5) Hepatic encephalopathy, terminal liver disease (Child Pugh B/C), renal insufficiency (6) Current users of Midazolam (7) Have serious hearing or Visual impairment, unable to communicate effectively with doctors; Unable to understand the content of the scale, rejecting participants (8) People allergic to Midazolam (9) Angle closure glaucoma (10) Pregnancy

Design outcomes

Primary

Measure	Time frame
Delirium incidence rate;	—

Secondary

Measure	Time frame
The incidence of delirium during ICU;The incidence of delirium on the 1st, 3rd, and 5th day after leaving the ICU;The proportion of patients who experience coma (RASS = -4);Number of ICU days without coma after random grouping; Number of ICU days without delirium;Mechanical ventilation time;Duration of delirium;The total amount of sedative and analgesic drugs used 24 hours before the first delirium diagnosis is confirmed;sleep quality;	—

Measure

Time frame

The incidence of delirium during ICU;The incidence of delirium on the 1st, 3rd, and 5th day after leaving the ICU;The proportion of patients who experience coma (RASS = -4);Number of ICU days without coma after random grouping; Number of ICU days without delirium;Mechanical ventilation time;Duration of delirium;The total amount of sedative and analgesic drugs used 24 hours before the first delirium diagnosis is confirmed;sleep quality;

—

Countries

China

Contacts

Public ContactZhang Yueying

Affiliated Hospital of Xuzhou Medical University

zyy0218@126.com+86 189 1574 5293

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026