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Sedating Effects of Dexmedetomidine Versus Midazolam in Agitated Patients Undergoing Weaning in Icu.

Sponsor
Sheikh Zayed Medical College (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05264077
Collaborator
(none)
66
Enrollment
2
Arms
10
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Comparison of sedating effect of dexmedetomidine and midazolam for sedation in icu patients who put on mechanical ventilation and undergoing weaning. Selction of better sedating agent minimises the drug related side effects like respiratory depression but also helps in weaning in shorter time,give hemodynamic stability and reduce morbidity and mortality in icu..

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexmedetomidine Hydrochloride
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Health Services Research
Official Title:
Sedating Effects of Dexmedetomidine Versus Midazolam in Agitated Patients Undergoing Weaning in ICU
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dexmedetomidine

Inj.Dexmedetomidine(precidex ) 200mcg/2ml Given to participants in infusion form for 24 hours

Drug: Dexmedetomidine Hydrochloride
Inj dexmedetomidine and inj midazolam given to two groups of participants and effects of both drugs will be observed for 24 hrs
Other Names:
  • Midazolam

    		•
    Experimental: Midazolam

    Inj.midazolam 5mg/ml given to participants in infusion form for 24 hrs

    Drug: Dexmedetomidine Hydrochloride
    Inj dexmedetomidine and inj midazolam given to two groups of participants and effects of both drugs will be observed for 24 hrs
    Other Names:
  • Midazolam

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effective sedation in icu patients lead to successful weaning in icu patients [Upto 48 hrs]

      Assess patients by using ramsay sedation score (score 1 =awake upto score 6=no response)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • all patients with age <60 irrespective of gendre
    Exclusion Criteria:
    • 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sheikh Zayed Medical College

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Momal Jaleel Khan, Dr.Momal jaleel khan, Sheikh Zayed Medical College
    ClinicalTrials.gov Identifier:
    NCT05264077
    Other Study ID Numbers:
    • MJKhan
    First Posted:
    Mar 3, 2022
    Last Update Posted:
    Mar 3, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Psychomotor Agitation
    Midazolam
    Dexmedetomidine

    Study Results

    No Results Posted as of Mar 3, 2022