Effect of Remimazolam With Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared With Midazolam

NCT05160987 | Recruiting DMC

• 1 other identifier: 2021-KY-089-02
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

In this parallel, multicenter, single-blind randomized controlled trial, mechanical ventilated patients will be randomly assigned to two groups. One receives remimazolam to achieve sedation goals, while the other receives Midazolam. The primary outcome is the effect of remimazolam on duration of mechanical ventilated of critical patients compared to midazolam.

Conditions

Sedation and Analgesia

Keywords

Remimazolam; Midazolam; duration of mechanical ventilation; Sedation

Outcome Measures

Primary Outcomes (1)

• Duration of mechanical ventilation

  Weaning success is typically regarded as consecutive ventilator-free over 24h following liberation from a ventilator. The duration of mechanical ventilation is from the enrollment time to the weaning time. The study and observation would be stopped due to difficult ventilator weaning, which features weaning failure repeatedly for 3 weeks.

  From the date of enrollment until the date of successful ventilator withdrawal, assessed up to 28 days

Secondary Outcomes (6)

• Duration of endotracheal intubation

  From the date of enrollment until the date of pulling out the endotracheal tube, assessed up to 28 days

• Completion rate of sedation goal

  From the date of enrollment until the date of successful ventilator withdrawal, assessed up to 28 days

• Remediation is defined as requiring combination with other sedations

  From the date of enrollment until the date of successful ventilator withdrawal, assessed up to 28 days

• Length of stay in ICU and total length of stay

  From the date of admission in ICU until the date of transfer from ICU

• Anterograde amnesia

  From the date of enrollment until the date of successful ventilator withdrawal

Study Arms (2)

Remimazolam Group

EXPERIMENTAL

The patients are administered with sedation of remimazolam and analgesia of remifentanil on the basis of routine treatment. If the patient does not receive sedative drug before enrollment, patient would be administered with a bolus of remimazolam with 0.1-0.3mg/kg intravenously in 1 minute for the first time. And maintenance dose is 0.25-0.1mg/kg/h, meanwhile the dose of remimazolam should be titrated according to RASS scores. Nonbenzodiazepines could be administrated to the patients if sedation targets were not achieved, and the medication and dosage is recorded.

Drug: Remimazolam

Midazolam Group

PLACEBO COMPARATOR

The patients are administered with sedation of midazolam analgesia of remifentanil on the basis of routine treatment. If the patient does not receive sedative drugs before enrollment, patients would be administered with a bolus of midazolam with 0.01-0.05mg/kg intravenously in 1 minute for the first time. And the maintenance dose is 0.02-0.1mg/kg/h, meanwhile the dose of midazolam should be titrated according to RASS scores. Nonbenzodiazepines could be administrated to the patients if sedation targets were not achieved, and the medication and dosage is recorded.

Drug: Midazolam

Interventions

Remimazolam DRUG

Remimazolam will be diluted with 0.9% saline to ensure that the therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.

Remimazolam Group

Midazolam DRUG

Midazolam will be diluted with 0.9% saline to ensure that the therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.

Midazolam Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Critical ill patients that are mechanically ventilated within the first 48h of admission to the ICU and who would remain in the ICU for over 72h were enrolled in this study.
• Age 18-80 years.
• Voluntary informed consent.

You may not qualify if:

• Surgical treatment is performed within 24 hours.
• Craniocerebral injury, post neurosurgery, non drug coma, mental illness or peripheral neuropathy.
• Heart rates are less than 50 beats / min or severe atrioventricular block without pacemaker support.
• The mean arterial pressure is less than 55 mmHg even though fluids and vasoactive drugs are administrated.
• Patients who are known or suspected allergy to benzodiazepines, propofol, dexmedetomidine or opioids.
• History of alcohol and drug abuse.
• End stages of lung diseases, such as pulmonary fibrosis, lung damage, etc.
• Pregnancy.

Sponsors & Collaborators

• Zhujiang Hospital: lead
• Affiliated Hospital of Guangdong Medical University: collaborator
• Integrated traditional Chinese and Western Medicine Hospital of Southern Medical University: collaborator
• First Affiliated Hospital of Shantou University Medical College: collaborator
• Yunfu People's Hospital: collaborator
• Zhongshan Hospital Of Traditional Chinese Medicine: collaborator
• Guangdong Province Traditional Medical hospital: collaborator
• The Third Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (1)

Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University

Guangzhou, Guangdong, 510282, China

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

remimazolam; Midazolam

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Zhanguo Liu, M.D.PhD

  Department of Critical Care Medicine of Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Cai

CONTACT

+86-2062782927; caijing78@hotmail.com

Zhanguo Liu, M.D.PhD

CONTACT

+86-2062782927; zhanguoliu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician of critical medicine department

Model Details: The participants in remimazolam group receive intravenous remimazolam. The participants in midazolam group receive midazolam.

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 16, 2021
• Study Start: March 29, 2022
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)