Efficacy of Dexmedetomidine vs Midazolam for Early Extubation in Critically Ill Agitated Patients Undergoing Weaning

August 6, 2024 updated by: Momal Jaleel Khan, Sheikh Zayed Medical College

Efficacy of Dexmedetomidine Versus Midazolam for Early Extubation in Critically Ill Agitated Patients Undergoing Weaning

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..

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective sedation in icu patients lead to successful 1weaning in icu patients
Time Frame: Upto 48 hrs
Assess patients by using ramsay sedation score (score 1 =awake upto score 6=no response)
Upto 48 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheikh Zayed Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

February 22, 2022

First Submitted That Met QC Criteria

February 22, 2022

First Posted (Actual)

March 3, 2022

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MJKhan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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