Remimazolam for Sedation in ICU Patients Undergoing Mechanical Ventilation

• Sponsor: Tianjin Nankai Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04815265
• Collaborator: (none)
• Enrollment: 488
• Arms: 2
• Anticipated Duration (Months): 39

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sedation	Drug: Remimazolam; Drug: Dexmedetomidine	Phase 4

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 488 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Efficacy and Safety of Remimazolam for Sedation in ICU Patients Undergoing Mechanical Ventilation: a Single Center, Randomized, Controlled, Non-inferiority Trial
• Anticipated Study Start Date: Apr 1, 2021
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group Participants in the experimental group received remimazolam for sedation	Drug: Remimazolam; Remimazolam is used for sedation
Active Comparator: Control group participants in the control group received dexmedetomidine for sedation	Drug: Dexmedetomidine; Dexmedetomidine is used for sedation

Outcome Measures

Primary Outcome Measures

1. Time to reach targeted sedation goals [an average of 1-2 year]

   the ratio of the time to reach the target sedation (RASS score, 0 to -3) in the total duration of drug infusion

2. the duration of mechanical ventilation [average of 1-2 year]

   Duration of mechanical ventilation in ICU

Secondary Outcome Measures

1. Length of stay in hospital [2 years]

   Length of stay in hospital

2. Length of stay in ICU [about 2 years]

   Length of stay in hospital

3. Total expenses during hospitalization [24 months]

   Total expenses during hospitalization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Tianjin Nankai Hospital

Investigators

• Study Chair: Jianbo Yu, Tianjin Nankai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Jianbo Yu, Department of Anesthesiology and Critical Care Medicine, Tianjin Nankai Hospital
• ClinicalTrials.gov Identifier: NCT04815265
• Other Study ID Numbers: NKYY_YWKT_IRB_2020_007_01
• First Posted: Mar 24, 2021
• Last Update Posted: Mar 24, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jianbo Yu, Department of Anesthesiology and Critical Care Medicine, Tianjin Nankai Hospital: Sedation; Mechanical Ventilation
• Additional relevant MeSH terms: Dexmedetomidine

Study Results

No Results Posted as of Mar 24, 2021