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Sedation During Mechanical Ventilation Comparing Two Drugs

Comparison Of The Sedative Effects Of Intravenous Dexmedetomidine Versus Midazolam Plus Fentanyl For Post Operative Elective Mechanical Ventilation - A Randomised Control Trial - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092792
Enrollment
92
Registered
2025-08-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Dexmedetomidine: inj.Dexmedetomidine will be started as a loading dose of 1mcg /kg over15minutes followed by an infusion rate of 0.2 - 0.7 mcg/kg/hour to maintain a RASS score of -3 or

Sponsors

SRM medical college and research centre,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age more than 18 years to less than 60 years ASA I ,II,III Mechanical ventilated patients for less than 24hours

Exclusion criteria

Exclusion criteria: Patient with decompensated cardiovascular,Neurological,Renal and Hepatic diseases. Allergy to any of the study drugs Patient on Ionotropes or Vasopressor support Pregnant patients. patient non consent. patient with chronic opioid dependence. Blood loss more than 1.5litres.

Design outcomes

Primary

MeasureTime frame
the level of sedation with Dexmedetomidine and Midazolam plus Fentanyl using the Richmond Agitation Sedation Score(RASS).Timepoint: the level of sedation with Dexmedetomidine and Midazolam plus Fentanyl using the Richmond Agitation Sedation Score(RASS).

Secondary

MeasureTime frame
Behavioural pain scale assessment. Time taken for Extubation. Hemodynamic changesTimepoint: hourly for first four hours and every fifth hourly till 24 hours

Countries

India

Contacts

Public ContactYuvaraj Ponnambalam

SRM medical college and research centre,

pushpara1@srmist.edu.in9003242601

Outcome results

None listed

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