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

Agitation on Recovery From Sedation Clinical Trial

Official title:

Sedating Effects of Dexmedetomidine Versus Midazolam in Agitated Patients Undergoing Weaning in ICU

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05264077
• Other study ID #: MJKhan
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: February 2022
• Source: Sheikh Zayed Medical College
• Contact: Momal j Khan
• Phone: 03116660901
• Email: momal.rehan56[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Agitation on Recovery From Sedation
• Psychomotor Agitation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheikh Zayed Medical College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Upto 48 hrs