NCT05782894

Brief Summary

A randomized non-inferior trial comparing remimazolam besylate with propofol for short-term sedation during invasive mechanical ventilation in intensive care units

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 18, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

February 28, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2023

Completed
Last Updated

January 31, 2024

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

February 18, 2023

Last Update Submit

January 29, 2024

Conditions

SedativeMechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • Successful sedation

    70% of time in the target sedation range in participants without rescue sedation

    24 hours

Secondary Outcomes (4)

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

    24 hours

  • Number of patients needing rescue sedation

    24 hours

  • Number of patients needing repeated boluses of the study drug

    24 hours

  • The amount of remifentanil in ug/kg/h

    24 hours

Other Outcomes (2)

  • Hypotension

    24 hours

  • Delirium

    24 hours

Study Arms (2)

Remimazolam besylate

EXPERIMENTAL

Remimazolam besylate

Drug: Remimazolam besylateDrug: Remifentanil

Propofol

ACTIVE COMPARATOR

Propofol

Drug: PropofolDrug: Remifentanil

Interventions

Remimazolam besylateDRUG

0\~2.0mg/kg/h

Remimazolam besylate
PropofolDRUG

0.3\~4.0mg/kg/h

Propofol
RemifentanilDRUG

1.5\~12μg/kg/h

PropofolRemimazolam besylate

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
  • Body mass index (BMI) ≥18 and ≤ 30 kg/m2
  • Being Intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on ventilator for at least 6 hours
  • Requirement for light to moderate sedation (a Richmond agitation-sedation scale score of -2 to 1)

You may not qualify if:

  • Refusal to be included
  • Allergy or unsuitability to any composition of study drugs or remifentanil
  • Living expectancy less than 48 hours
  • Myasthenia gravis
  • Status asthmaticus
  • Abdominal compartment syndrome
  • Serious hepatic dysfunction (CTP 10-15);
  • Chronic kidney disease with glomerular filtration rate (GFR) \< 29 ml/min/1.73m2
  • Mean blood pressure less than 65 mm Hg or the need of a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain Mean blood pressure ≥ 65 mm Hg
  • Possible requirement for surgery or bedside tracheostomy in 24 hours
  • Possible requirement for renal replacement therapy in 24 hours
  • Acute severe neurological disorder and any other condition interfering with sedation assessment
  • Abuse of controlled substances or alcohol
  • Pregnancy or lactation
  • Other conditions deemed unsuitable to be included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

Related Publications (1)

  • Tang Y, Shu H, Ren L, Li R, Zou X, Qi H, Ouyang Y, Wu Y, Xu J, Fang X, Yang X, Shang Y. Remimazolam Besylate Versus Propofol for Short-Term Sedation in Critically Ill Patients Receiving Mechanical Ventilation: Protocol for a Multicenter Randomized Non-inferior Trial. Adv Ther. 2025 Aug;42(8):4081-4088. doi: 10.1007/s12325-025-03268-7. Epub 2025 Jun 10.

    PMID: 40493335DERIVED

MeSH Terms

Interventions

PropofolRemifentanil

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2023

First Posted

March 24, 2023

Study Start

February 28, 2023

Primary Completion

November 25, 2023

Study Completion

November 25, 2023

Last Updated

January 31, 2024

Record last verified: 2023-12

Locations

CN(1)