Efficacy of Dexmedetomidine vs Midazolam for Early Extubation in Critically Ill Agitated Patients Undergoing Weaning
Efficacy of Dexmedetomidine Versus Midazolam for Early Extubation in Critically Ill Agitated Patients Undergoing Weaning
1 other identifier
interventional
66
0 countries
N/A
Brief Summary
Comparison of effect of dexmedetomidine and midazolam in icu patients who put on mechanical ventilation and show agitation on weaning.Selection of better agent minimises the drug related side effects like respiratory depression but also helps in weaning for early extubation,give hemodynamic stability and reduce morbidity and mortality in icu..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Nov 2024
Shorter than P25 for early_phase_1
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
February 22, 2022
CompletedFirst Posted
Study publicly available on registry
March 3, 2022
CompletedStudy Start
First participant enrolled
November 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedAugust 7, 2024
August 1, 2024
8 months
February 22, 2022
August 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Effective sedation in icu patients lead to successful 1weaning in icu patients
Assess patients by using ramsay sedation score (score 1 =awake upto score 6=no response)
Upto 48 hrs
Study Arms (2)
Dexmedetomidine
EXPERIMENTALInj.Dexmedetomidine(precidex ) 200mcg/2ml Given to participants in infusion form for 24 hours
Midazolam
EXPERIMENTALInj.midazolam 5mg/ml given to participants in infusion form for 24 hrs
Interventions
Inj dexmedetomidine and inj midazolam given to two groups of participants and effects of both drugs will be observed for 24 hrs
Eligibility Criteria
You may qualify if:
- all patients with age \<60 irrespective of gendre
You may not qualify if:
- \- Patients who refuse to give consent, severely altered conscious level (GCS \< 8/15), traumatic injury causing hypoxemia e.g., severe head / chest / facial trauma or pneumothorax, severe pneumonia, arrhythmia, impaired hearing or blindness, severe hepatic or renal disease, on neuromuscular blocking agents, recent myocardial infarction, use of anti-psychotics, hypersensitivity to any of the drug under study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.Momal jaleel khan
Study Record Dates
First Submitted
February 22, 2022
First Posted
March 3, 2022
Study Start
November 1, 2024
Primary Completion
June 30, 2025
Study Completion
July 31, 2025
Last Updated
August 7, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share