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Status unknownNCT05264077Updated Aug 7, 2024

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

An Early Phase 1 interventional study of Dexmedetomidine Hydrochloride in Agitation, Emergence, sponsored by Sheikh Zayed Medical College. Status unknown. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-07.

Sponsored by Sheikh Zayed Medical College · Early Phase 1, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Aug 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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..

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Conditions studied

  • Agitation, Emergence

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03

In context

Emergence Delirium

788 studies on the registry are indexed under Emergence Delirium; 250 are open to participants now.

This study's planned enrollment of 66 is below the median of 120 across 491 interventional studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

Sheikh Zayed Medical College is the lead sponsor of 27 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • all patients with age \<60 irrespective of gendre

Exclusion criteria

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.

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Study design

Phase
Early Phase 1
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
66 participants (estimated)

Study arms

  • Experimental
    Dexmedetomidine

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

    Drug: Dexmedetomidine Hydrochloride

  • Experimental
    Midazolam

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

    Drug: Dexmedetomidine Hydrochloride

Interventions

  • Inj dexmedetomidine and inj midazolam given to two groups of participants and effects of both drugs will be observed for 24 hrs

    Also known as: Midazolam

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What researchers measure

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)

    Time frame: Upto 48 hrs

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05264077
Lead sponsor
Sheikh Zayed Medical College
Responsible party
Momal Jaleel Khan (Dr.Momal jaleel khan, Sheikh Zayed Medical College) — Principal investigator
First posted
Mar 3, 2022
Start date
Nov 1, 2024 (estimated)
Primary completion
Jun 30, 2025 (estimated)
Completion
Jul 31, 2025 (estimated)
Last update
Aug 7, 2024

Study contacts

Momal j Khan
Contact
momal.rehan56@gmail.com
03116660901

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Dexmedetomidine

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