Recruiting

Remazolam Besylate for Sedation in ICU Patients After Surgery

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What is being tested

Remimazolam Besylate

+ Dexmedetomidine Hydrochloride

Drug
Who is being recruted

Pathologic Processes+3

+ Pathological Conditions, Signs and Symptoms

+ Critical Illness

From 18 to 64 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: January 2025
See protocol details

Summary

Principal SponsorBeijing Shijitan Hospital, Capital Medical University
Study ContactYuefu Wang, doctorMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleEfficacy and Safety of Remazolam Besylate in Patients Requiring Mechanical Ventilation Admitted to ICU After Non-cardiac Surgery: Protocol for a Randomized, Controlled No-inferiority Trial
NCT06575530
Principal SponsorBeijing Shijitan Hospital, Capital Medical University
Study ContactYuefu Wang, doctorMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

306 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Pathologic ProcessesPathological Conditions, Signs and SymptomsCritical IllnessDisease AttributesChemically-Induced DisordersDrug-Related Side Effects and Adverse Reactions

Criteria

6 inclusion criteria required to participate
18-64 years old

must accept no-cardiac elective surgery

must under general anaesthesia

can be combined regional tissue anesthesia

Show More Criteria

10 exclusion criteria prevent from participating
intracranial surgery or severe neurological or spinal cord disease

schizophrenia, epilepsy, and Parkinson's disease

coma, severe dementia, or language barrier before surgery

cardiac dysfunction or arrhythmia

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Light sedation will started when the patient admitted to ICU after non-cardiac surgery under general anesthesia with remimazolam besylate which will continuously intravenously pumped at a rate of 0.2-1.0mg/kg/h . Depth of sedation will assessed by RASS hourly to ensure a RASS score of 0 to -2. Adjust the dosage of remimazolam (increase or decrease) based on the RASS score. At the same time, use remifentanil (0.1-0.5/kg/min) as a combination analgesic drug to ensure that the CPOT is ≤2 points. When a satisfactory level of RASS score (0 to -2 points) is still not achieved within the upper limit of remimazolam, a remedial sedation will started using propofol. Researchers assess the patient daily during the ICU stay whether to terminate sedative drug, weaning and extubation, and compete the outcomes assessment.

Group II

Active Comparator
Light sedation will started when the patient admitted to ICU after non-cardiac surgery under general anaesthesia with dexmedetomidine, which will continuously intravenously pumped at a rate of 0.2-0.7ug/kg/h. Depth of sedation will assessed by RASS hourly to ensure a RASS score of 0 to -2. Adjust the dosage of dexmedetomidine (increase or decrease) based on the RASS score. At the same time, use remifentanil (0.1-0.5/kg/min) as a combination analgesic drug to ensure that the CPOT is ≤2 points. When a satisfactory level of RASS score (0 to -2 points) is still not achieved within upper limit of dexmedetomidine, a remedial sedation will started using propofol. Researchers assess the patient daily during the ICU stay whether to terminate sedative drug, weaning and extubation, and compete the outcomes assessment.

Study 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

Recruiting

Beijing Shijitan Hospital.CMU

Beijing, ChinaOpen Beijing Shijitan Hospital.CMU in Google Maps
Recruiting
One Study Center