Remazolam Besylate for Sedation in ICU Patients After Surgery
Remimazolam Besylate
+ Dexmedetomidine Hydrochloride
Pathologic Processes+3
+ Pathological Conditions, Signs and Symptoms
+ Critical Illness
Treatment Study
Summary
Study start date: January 20, 2025
Actual date on which the first participant was enrolled.This study focuses on comparing the effectiveness and safety of a medication called remazolam besylate with another drug, dexmedetomidine, for patients who need help breathing with a machine after having non-heart-related surgery. The patients involved are those in the intensive care unit (ICU) who require sedation, which means they need to be in a calm or sleep-like state to tolerate the breathing machine. This research is significant because finding the safest and most effective sedative can improve the care of patients who are critically ill and need mechanical ventilation, reducing potential complications and enhancing recovery. Participants in this study are randomly assigned to receive either remazolam besylate or dexmedetomidine, ensuring that neither the patients nor the researchers know which drug is being administered to avoid bias. The medication is likely given through an IV, which is a common method for delivering sedatives in the ICU. The study assesses how well each drug works in keeping patients sedated and monitors any side effects to determine if remazolam besylate is as safe and effective as dexmedetomidine. This ensures that the best possible sedation method is used for patients, providing both comfort and safety during their recovery.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.306 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 64 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location