Remimazolam for Sedation in ICU Patients Undergoing Mechanical Ventilation

Sedation Clinical Trial

Official title:

Efficacy and Safety of Remimazolam for Sedation in ICU Patients Undergoing Mechanical Ventilation: a Single Center, Randomized, Controlled, Non-inferiority Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04815265
• Other study ID #: NKYY_YWKT_IRB_2020_007_01
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2021
• Source: Tianjin Nankai Hospital
• Contact: Yuan Zhang, PHD
• Phone: 13642066361
• Email: 13642066361[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

1. Title: Efficacy and Safety of Remimazolam for Sedation in ICU Patients Undergoing Mechanical Ventilation

2. Research center: Single Center

3. The Design of the study: Randomized, Controlled, Non-inferiority Trial

4. The population of the study: The main inclusion criteria are 18 years old or above, invasive mechanical ventilation is required, and the clinical need is mild to moderate Sedated (RASS score 0 to -3) patients

5. Sample size: Enroll 488 patients (244patients in each group)

6. Interventions: Participants in the test group received remimazolam for sedation, while participants in the control group received dexmedetomidine, The analgesia drug in two group is fentanyl.

7. The aim of the research: To investigate the efficacy and safety of remimazolam for sedation in ICU patients undergoing mechanical ventilation

8. Outcome# 1) Primary outcome# the ratio of the time to reach the target sedation (RASS score, 0 to -3)in the total duration of drug infusion, and the duration of mechanical ventilation. 2)Secondary outcome#; Length of stay in ICU and Length of stay in hospital; Incidence of complications (including re-hospitalization); Total expenses during hospitalization

9. The estimated duration of the study#2-3years

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 488
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

The main inclusion criteria are 18 years old or above, invasive mechanical ventilation is required, and the clinical need is mild to moderate Sedated (RASS score 0 to -3) patients.

Exclusion Criteria:

1. Refuse to participate in this study

2. Patients with severe bradycardia (HR<50 bpm)

3. Patients who is pregnancy

4. Patients with brain injury or neurosurgery

5. Patients receiving sedation for treatment indications (such as epilepsy), not to tolerate a ventilator.

6. Patients receiving any study medication within 30 days

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• Remimazolam
Remimazolam is used for sedation
• Dexmedetomidine
Dexmedetomidine is used for sedation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Nankai Hospital

References & Publications (4)

Antonik 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, an — View Citation

Barr J, Fraser GL, Puntillo K, Ely EW, Gélinas 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. Review. — View Citation

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. — View Citation

Shehabi 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 Critic — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	the duration of mechanical ventilation	Duration of mechanical ventilation in ICU	average of 1-2 year
Secondary	Length of stay in hospital	Length of stay in hospital	2 years
Secondary	Length of stay in ICU	Length of stay in hospital	about 2 years
Secondary	Total expenses during hospitalization	Total expenses during hospitalization	24 months