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A comparative study between two drugs that commonly induces the nervous system to calm named Dexmedetomidine and Midazolam in patients who are on ventilator in Intensive Care Units

To compare the efficacy and safety of prolonged sedation with Dexmedetomidine vs Midazolam for mechanically ventilated patients in the Intensive care unit

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/07/002844
Enrollment
60
Registered
2012-07-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- ICU Patients

Interventions

Intervention1: (up to 1 microgram/kg dexmedetomidine or 0.05mg/kg midazolam): Each patient will receive study drug within 48hrs after intubation. Control Intervention1: Dexmedetomidine: Dexmedetomidin

Sponsors

MEDANTA THE MEDICITY
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Consent by Legally Acceptable Representative •More than 18years of age. •In tuba ted and mechanically ventilated for less than 48 hours •Anticipated ventilation and sedation duration of at least 3 more days.

Exclusion criteria

Exclusion criteria: • Undergoing dialysis of any type • Pregnancy or lactation • Neuromuscular blockade other than for intubation • Epidural or spinal analgesia at the time of screening assessment • General anesthesia 24 hours prior to or planned at the time of the screening assessment. • Serious central nervous system pathology(acute stroke, uncontrolled seizures ,severe dementia) • Acute hepatitis or severe liver disease (Child-Pugh class C) • Unstable angina or acute myocardial infarction or left ventricular ejection fraction less than 30% • Heart rate less than 50/min • Second- or third degree heart block, or systolic blood pressure less than 90 mm Hg despite continuous infusions of 2 vasopressors before the start of study drug infusion. • History of microvascular flap surgical procedures cerebrovascular surgery or with a risk of vasospasm in the last three months.

Design outcomes

Primary

MeasureTime frame
To compare days of mechnical ventilation in patients receiving dexmedetomidine versus MedazolamTimepoint: 6 months

Secondary

MeasureTime frame
â?¢ Mortality in each group. â?¢ For each group the prevalence and duration of delirium, use of extra sedation and nursing assessments will also be reviewed. Sedation level and delirium will be assessed using the Richmond Agitation-Sedation Scale (RASS) and CAM(confusion assessment method)-ICU methods.Timepoint: 6 months

Countries

India

Contacts

Public ContactRajat Gupta

MEDANTA THE MEDICITY

rajat.gupta@medanta.org

Outcome results

None listed

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