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Evaluation of the sedative effect of subcutaneous midazolam and subcutaneos methadone in intensive care unit

Evaluation and compression of the sedative effect of subcutaneous midazolam and subcutaneos methadone in intensive care unit

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160307026950N75
Enrollment
32
Registered
2026-01-10
Start date
2026-01-21
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Level of sedation in the ICU.

Interventions

Intervention 1: Intervention group 1: In this group, patients are assessed for disease severity and hemodynamic status upon admission to the ICU, and their vital signs are recorded. Then, they receive

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients admitted to the ICU with a physical status of ASA II or ASA III Age between 18 and 60 years Need for light sedation at the discretion of the attending physician Written consent from the patient or legal guardian in case of anesthesia or decision-making incapacity

Exclusion criteria

Exclusion criteria: Known hypersensitivity to midazolam or other benzodiazepines or methadone Severe hepatic or renal impairment Concomitant use of other potent sedatives Pregnancy or lactation Severe hemodynamic or respiratory disorders that, in the opinion of the attending physician, preclude entry into the study

Design outcomes

Primary

MeasureTime frame
Sedation level. Timepoint: At 15, 30, 60 and 120 minutes after injection. Method of measurement: Ramsay scale.;Side effects include hypotension, difficulty breathing, and local reactions at the injection site. Timepoint: At 15, 30, 60 and 120 minutes after injection. Method of measurement: By observing and assessing hemodynamic status.;Satisfaction of medical staff. Timepoint: After the end of the interventions in each patient. Method of measurement: Standard questionnaire with Likert scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehzad Nazem Roaya Sade

Esfahan University of Medical Sciences

behzad_nazem@med.mui.ac.ir+98 31 3792 3071

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026