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Comparative effect of Lorazepam with Midazolam in sedative of patients under mechanical ventilatin hospitalized

Comparative effect of Lorazepam with Midazolam in sedative of patients under mechanical ventilatin hospitalized in Intensive care unit of Imam Khomeyni Hospital

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220424054631N1
Enrollment
110
Registered
2022-05-14
Start date
2022-04-30
Completion date
Unknown
Last updated
2022-05-30

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

Conditions

Patients under mechanical ventilation admitted to the intensive care unit.

Interventions

Intervention 1: Intervention group: Group L patients will receive 2 mg of lorazepam every 2 hours for 12 hours (12 mg). The drug will be diluted and infused in 250 cc of normal saline 0.9%. Interventi

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Pulmonary patients under mechanical ventilation with appropriate level of consciousness (equivalent to GCS=10) Age 18-65 years Patients who have not received benzodiazepines in the last 72 hours

Exclusion criteria

Exclusion criteria: Patients with inadequate level of consciousness GCS <10 Patients with unstable hemodynamics Allergy to benzodiazepines or contraindications to the use of benzodiazepines Age under 18 or over 65 years Patients with neurological disorders, kidney or liver failure Patients who have recently received or are dependent on long-acting benzodiazepines

Design outcomes

Primary

MeasureTime frame
Comparison of the sedative effect of lorazepam with midazolam. Timepoint: Patients will be assessed at injection start times of 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, and 12 hours after the start of the infusion. Method of measurement: During current study patients' demographic information (age and sex), body mass index, blood pressure, heart rate, respiratory rate, oxygen saturation( via pulse oximetry), level of consciousness (by Glasgow coma scale) and level of sedation ( by Richmond sedation scale and Ramsay sedation scale) will be recorded in a checklist prepared by the researcher. Also, the total amount of midazolam and lorazepam that will be used, their prices, duration of mechanical ventilation, duration of hospitalization ( either in intensive care unit or ward) and the mortality rate of patients will be recorded.

Secondary

MeasureTime frame
Richmond benchmark score. Timepoint: Patients will be evaluated at 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, and 12 hours after the start of the infusion. Method of measurement: - Aggressive, aggressive (fierce, militant, with violent and dangerous movements for themselves and others) +4- Very restless (aggressive, restless, kills tubes and catheters, dangerous for himself) +3- Restless (repetitive movements, aimless, fighting with mechanical ventilation) +2- Restless (has worries and fears, excited; but not aggressive and restless) +1- Calm-conscious (with normal movements and behavior) 0- Sleepy - confused (not fully awake but can stay awake for more than 10 seconds (make eye contact against sound for more than 10 seconds)) 1-- Slightly mild (slight (mild) drowsiness stays awake for less than 10 seconds (making eye contact against sounding less than 10 seconds)) 2-- Medium calm (opens his eyes, moves in the direction of sound but without eye contact) 3-Intense calm (does not respond to sound, but responds to the therapist's physical stimuli)- No response (does not respond to the therapist's voice and physical stimuli) 5-.;Ramsay scoring system. Timepoint: Patients will be evaluated at 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, and 12 hours after the start of the infusion. Method of measurement: Can not be assessed 0 is fully conscious 1 is drowsy, wakes up without stimulus 2 is drowsy, who wakes up with vocal stimulation 3 is drowsy and wakes up with a bang on the shoulder and loudly 4 is drowsy and wakes up with a bang on the face and a loud voice 5 is drowsy and does not respond to blows to the face and loud voice.;Glasgow Index. Timepoint: Patients will be evaluated at baseline and 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, and 12 hours after infusion. Method of measurement: An index to report the severity of anesthesia in a person with a score of 4 to 15.;Body mass index. Timepoint: Start studying. Method of measurement: ?? ??? Kg/m2.;Cau

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohamadamin Valizadeh Hasanloui

Oroumia University of Medical Sciences

aminvalizade@yahoo.com+98 44 3348 5325

Outcome results

None listed

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