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Compares treatment options for Sedation and Analgesia
Official title Effect of Remimazolam With Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared With Midazolam
ClinicalTrials.gov ID: NCT05160987
What this study is testing
What is Remimazolam?
Remimazolam is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for sedation and analgesia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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...
- Age 18-80 years.
- Voluntary informed consent.
You likely can't join 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.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.