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A Prospective, Comparative Clinical Study of Two Sedatives for Patients Needing Invasive Breathing Support (Ventilator) in ICU

A Prospective, Randomised Double-blind Clinical Study of IV Midazolam Vs IV Lorazepam for Sedation in ICU Patients Requiring Mechanical Ventilation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/051210
Enrollment
126
Registered
2023-03-31
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: R688- Other general symptoms and signs

Interventions

Intervention1: IV Lorazepam: Lorazepam will be delivered via a syringe pump at a concentration of 0.16mg/ml Control Intervention1: IV midazolam: IV midazolam will be delivered via a syringe pump at a

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All adults of either gender between the age of 18 â?? 85 years on mechanical ventilation requiring sedation for at least 3 days not included in the exclusion criteria.

Exclusion criteria

Exclusion criteria: 1. Consent refusal 2. Patients with h/o chronic benzodiazepine use 3. Patients with h/o allergy to either drug 4. Patients who require pharmacologic neuromuscular blockade for maintenance of mechanical ventilation 5. Patients who are mechanically ventilated for 6. Pregnant patients

Design outcomes

Primary

MeasureTime frame
Duration of adequate sedation [expressed as percentage of time patient will be sedated at the desired level as determined by Richmond Agitation Sedation Scale (RASS) Score, measured from start of the infusion, until 24 hours after discontinuation of the drug or death of the patient].Timepoint: measured from start of the infusion, until 24 hours after discontinuation of the drug or death of the patient

Secondary

MeasureTime frame
Average cost of study medication per dayTimepoint: expressed in INR;Duration of mechanical ventilationTimepoint: measured in hours;Incidence of complications such as metabolic acidosis, hypotension or any other untoward adverse eventsTimepoint: expressed in whole number; measured during the study period;Length of hsopital stayTimepoint: days;Length of ICU stayTimepoint: days;Number of infusion rate adjustmentsTimepoint: expressed in whole number; measured during the study period;Number of therapeutic failuresTimepoint: expressed in whole numbers; measured during the study period;Time taken for extubation after discontinuation of the drugTimepoint: measured in hours;Time to achieve initial desired level of sedation.Timepoint: measured in hours (from starting of infusion)

Countries

India

Contacts

Public ContactDr Shivkumar Iyer

Bharati Vidyapeeth (DTU) Medical College

suchetashiva@gmail.com9822051719

Outcome results

None listed

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