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study to compare effect of Dexmedetomidine and Midazolam for sedation in patients on mechanical ventilation in ICU

A comparative study of Dexmedetomidine and Midazolam for sedation in patients on mechanical ventilation in ICU

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038987
Enrollment
78
Registered
2021-12-28
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J958- Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified

Interventions

Intervention1: To study the effect of injection dexmedetomidine for sedation in patients on mechanical ventilation in ICU: Patients will receive injecction dexmedetomidine with a bolus of 1micrograms/

Sponsors

Dr Sampurnanand
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Post operative patients with need of mechanical ventilation. Â

Exclusion criteria

Exclusion criteria: Patients who are hemodynamically unstable â?? bradycardia (heart rate Patients with neurological disease and active seizures. Patients with acute myocardial ischemia, second and third degree heart block etc. Diabetic patients with uncontrolled blood sugar level. Morbidly obese patients. Patients under 18 years and over 65 years of age. Known allergy to the drug. Pregnancy Patients with chronic liver disease. Patients on chronic opioid therapy or use of alpha 2 agonists or antagonist 24 hours prior to admission.

Design outcomes

Primary

MeasureTime frame
The primary efficacy outcome to be studied is the proportion of the time spent in the target sedation range ( RASS score 0 to -3).Timepoint: 24 hrs

Secondary

MeasureTime frame
To study the hemodynamic responses to administration of Dexmedetomidine and compare them with those of Midazolam. To study the advantage of use of Dexmedetomidine over Midazolam for sedation in the patients if any.  To study the effects of Dexmedetomidine and Midazolam on incidence and duration of delirium. To study the adverse effects of Dexmedetomidine if any and compare them with midazolam.  Timepoint: 24 hrs

Countries

India

Contacts

Public ContactDr Ajay Kumar Sinha

Govt. Medical College, Haldwani

drajayksinha@yahoo.co.in9897672301

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026