Remimazolam for Sedation in ICU Patients Undergoing Mechanical Ventilation
Efficacy and Safety of Remimazolam for Sedation in ICU Patients Undergoing Mechanical Ventilation: a Single Center, Randomized, Controlled, Non-inferiority Trial
1 other identifier
interventional
488
0 countries
N/A
Brief Summary
Sedation is a component of the care of critically ill patients who are undergoing mechanical ventilation. Dexmedetomidine induces sedation while preserving a degree of arousability among patients in the intensive care unit (ICU), and its use has resulted in a shorter time to extubation, an increased number of days free from coma or delirium, a reduced incidence of agitated delirium, prevention of delirium, and lower mortality than other agents administered in certain populations. Hypotension and bradycardia are common side effects, which is lethal for the patients with persistent or severe hemodynamic instability. The pharmacological properties of rimazolom suggest that it is an ideal sedative drug for critically ill patients, but there is no relevant clinical research to confirm it. Therefore, this study mainly discusses the efficacy and safety of remidazolam in ICU patients with mechanical ventilation, so as to provide theoretical basis for individualized sedation treatment of patients with mechanical ventilation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2021
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2021
CompletedFirst Posted
Study publicly available on registry
March 24, 2021
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedMarch 24, 2021
March 1, 2021
2.8 years
March 22, 2021
March 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time to reach targeted sedation goals
the ratio of the time to reach the target sedation (RASS score, 0 to -3) in the total duration of drug infusion
an average of 1-2 year
the duration of mechanical ventilation
Duration of mechanical ventilation in ICU
average of 1-2 year
Secondary Outcomes (3)
Length of stay in hospital
2 years
Length of stay in ICU
about 2 years
Total expenses during hospitalization
24 months
Study Arms (2)
Experimental group
EXPERIMENTALParticipants in the experimental group received remimazolam for sedation
Control group
ACTIVE COMPARATORparticipants in the control group received dexmedetomidine for sedation
Interventions
Eligibility Criteria
You may not qualify if:
- Refuse to participate in this study
- Patients with severe bradycardia (HR\<50 bpm)
- Patients who is pregnancy
- Patients with brain injury or neurosurgery
- Patients receiving sedation for treatment indications (such as epilepsy), not to tolerate a ventilator.
- Patients receiving any study medication within 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
Shehabi Y, Chan L, Kadiman S, Alias A, Ismail WN, Tan MA, Khoo TM, Ali SB, Saman MA, Shaltut A, Tan CC, Yong CY, Bailey M; Sedation Practice in Intensive Care Evaluation (SPICE) Study Group investigators. Sedation depth and long-term mortality in mechanically ventilated critically ill adults: a prospective longitudinal multicentre cohort study. Intensive Care Med. 2013 May;39(5):910-8. doi: 10.1007/s00134-013-2830-2. Epub 2013 Jan 24.
PMID: 23344834BACKGROUNDBarr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.
PMID: 23269131BACKGROUNDShehabi Y, Howe BD, Bellomo R, Arabi YM, Bailey M, Bass FE, Bin Kadiman S, McArthur CJ, Murray L, Reade MC, Seppelt IM, Takala J, Wise MP, Webb SA; ANZICS Clinical Trials Group and the SPICE III Investigators. Early Sedation with Dexmedetomidine in Critically Ill Patients. N Engl J Med. 2019 Jun 27;380(26):2506-2517. doi: 10.1056/NEJMoa1904710. Epub 2019 May 19.
PMID: 31112380RESULTAntonik LJ, Goldwater DR, Kilpatrick GJ, Tilbrook GS, Borkett KM. A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): Part I. Safety, efficacy, and basic pharmacokinetics. Anesth Analg. 2012 Aug;115(2):274-83. doi: 10.1213/ANE.0b013e31823f0c28. Epub 2011 Dec 20.
PMID: 22190555RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jianbo Yu
Tianjin Nankai Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Anesthesiology and Critical Care Medicine
Study Record Dates
First Submitted
March 22, 2021
First Posted
March 24, 2021
Study Start
April 1, 2021
Primary Completion
December 31, 2023
Study Completion
June 30, 2024
Last Updated
March 24, 2021
Record last verified: 2021-03