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Efficacy and safety of two drugs, midazolam and dexmedomidine, in sedation of children

Efficacy and safety of two drugs, midazolam, and dexmedetomidine, on the sedation of mechanically ventilated children

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190522043672N3
Enrollment
124
Registered
2023-02-16
Start date
2023-02-09
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Other side effects of anesthesia and sedation. Other complications of anesthesia

Interventions

Intervention 1: Intervention group: Dexmedomidine is injected intravenously. The bolus dose of the drug will be 0.5 micrograms per kilogram and the starting dose of the infusion will be 0.25 microgram

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Months to 18 Years

Inclusion criteria

Inclusion criteria: Suffering from dysfunction of the central nervous system, whether genetic or acquired

Exclusion criteria

Exclusion criteria: Having bradycardia Resistant hypotension during treatment

Design outcomes

Primary

MeasureTime frame
The rate of treatment failure and the need for a second sedative drug. Timepoint: The first day, the second day and the third day of the intervention. Method of measurement: Using the Ramsay score table.

Secondary

MeasureTime frame
Duration of reaching target sedation. Timepoint: The first, second and third day of the intervention. Method of measurement: Measuring time with a timer.;Duration of mechanical ventilation. Timepoint: The day of the patient's discharge. Method of measurement: patient file.;Bradycardia. Timepoint: daily during the intervention period. Method of measurement: Doctor supervision and clinical monitor.;Hypotension. Timepoint: daily during the intervention period. Method of measurement: Mercury sphygmomanometer.;Mortality rate. Timepoint: The last day of hospitalization. Method of measurement: patient file.;Duration of stay in PICU. Timepoint: The day of the patient's discharge. Method of measurement: patient file.;Re-evaluation of Ramsay score in successful patients at 6 hour later in follow-up. Timepoint: in follow-up. Method of measurement: Ramsay sedation scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMajid Sezavar

Mashhad University of Medical Sciences

sezavardm@mums.ac.ir+98 51 3870 9225

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 5, 2026