NCT05539521

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of remimazolam besylate compared to propofol for sedation in critically ill patients with deep sedation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

September 26, 2022

Status Verified

September 1, 2022

Enrollment Period

5 months

First QC Date

September 12, 2022

Last Update Submit

September 23, 2022

Conditions

Critically IllDeep Sedation

Keywords

Remimazolam besylatePropofolIntensive care unitDeep sedation

Outcome Measures

Primary Outcomes (1)

  • The percentage of time in the target sedation range without rescue sedation

    The percentage of time in the target sedation range without rescue sedation

    From the beginning of using study sedatives until being discharged from our ICU, the sedation target was changed, 48 hours after enrollment, or dead, whichever came first

Secondary Outcomes (5)

  • Adverse events

    From the beginning of using study sedatives until being discharged from our ICU, the sedation target was changed, 48 hours after enrollment, or dead, whichever came first

  • 7-day ventitlator free time

    From start of study to 7 days

  • Extubation at day 7

    From start of study to 7 days

  • Length of ICU stay

    From start of study to 28 days

  • 28-day mortality

    From start of study to 28 days

Study Arms (2)

Remimazolam Besylate

EXPERIMENTAL

Patients in the remimazolam group received remimazolam besylate at an initial infusion rate of 0.3 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64.

Drug: Remimazolam Besylate

Propofol

ACTIVE COMPARATOR

Patients in the propofol group received propofol at an initial infusion rate of 3.0 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64.

Drug: Propofol

Interventions

Remimazolam BesylateDRUG

sedation drugs

Remimazolam Besylate
PropofolDRUG

Propofol

Propofol

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 and ≤ 80 years;
  • Expected to require deep sedation ≥8 hours;
  • Requirement for deep sedation (a Narcotrend index between 13 and 64).

You may not qualify if:

  • Body mass index (BMI) \<18 or \>30 kg/m2;
  • Acute severe neurological disorder and any other condition interfering with RASS assessment;
  • Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors;
  • Heart rate less than 50 beats/min;
  • Second- or third-degree heart block in the absence of a pacemaker;
  • Unstable angina;
  • Acute myocardial infarction;
  • Left ventricular ejection fraction less than 30%;
  • Contraindicate or allergic to study drugs;
  • Moribund state;
  • Acute hepatitis or serious hepatic dysfunction (Child-Pugh class C);
  • Chronic kidney disease with glomerular filtration rate (GFR) \< 60 ml/min/1.73m2;
  • Alcohol abuse;
  • Myasthenia gravis;
  • Expected to have a general anesthesia within 8 hours;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

RECRUITING

MeSH Terms

Conditions

Critical Illness

Interventions

Propofol

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • You Shang, Professor

    Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaobo Yang, MD

CONTACT

+8602785351606want.tofly@aliyun.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 14, 2022

Study Start

September 5, 2022

Primary Completion

February 1, 2023

Study Completion

March 1, 2023

Last Updated

September 26, 2022

Record last verified: 2022-09

Locations

CN(1)