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

Primary Purpose

Agitation on Recovery From Sedation

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Dexmedetomidine Hydrochloride
Sponsored by
Sheikh Zayed Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Agitation on Recovery From Sedation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Dexmedetomidine

    Midazolam

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Effective sedation in icu patients lead to successful weaning in icu patients
    Assess patients by using ramsay sedation score (score 1 =awake upto score 6=no response)

    Secondary Outcome Measures

    Full Information

    First Posted
    February 22, 2022
    Last Updated
    February 22, 2022
    Sponsor
    Sheikh Zayed Medical College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05264077
    Brief Title
    Sedating Effects of Dexmedetomidine Versus Midazolam in Agitated Patients Undergoing Weaning in Icu.
    Official Title
    Sedating Effects of Dexmedetomidine Versus Midazolam in Agitated Patients Undergoing Weaning in ICU
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    March 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sheikh Zayed Medical College

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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..

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Agitation on Recovery From Sedation

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    66 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dexmedetomidine
    Arm Type
    Experimental
    Arm Description
    Inj.Dexmedetomidine(precidex ) 200mcg/2ml Given to participants in infusion form for 24 hours
    Arm Title
    Midazolam
    Arm Type
    Experimental
    Arm Description
    Inj.midazolam 5mg/ml given to participants in infusion form for 24 hrs
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine Hydrochloride
    Other Intervention Name(s)
    Midazolam
    Intervention Description
    Inj dexmedetomidine and inj midazolam given to two groups of participants and effects of both drugs will be observed for 24 hrs
    Primary Outcome Measure Information:
    Title
    Effective sedation in icu patients lead to successful weaning in icu patients
    Description
    Assess patients by using ramsay sedation score (score 1 =awake upto score 6=no response)
    Time Frame
    Upto 48 hrs

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Momal j Khan
    Phone
    03116660901
    Email
    momal.rehan56@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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