Magnesium sulfate and reducing sedative requirement

Evaluation of magnesium sulfate efficacy in reducing sedative requirement in patients under mechanical ventilation

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20100228003449N33

Enrollment

Registered

2024-12-11

Start date

2024-12-01

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

Management of pain, agitation/sedation and delirium in mechanically ventilated patients. Sedative, hypnotic, or anxiolytic related disorders

Interventions

Intervention 1: Control group: In addition to the sedation protocol, patients will receive placebo (saline). Intervention 2: Intervention group: In addition to the sedation protocol, patients will rec

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients in ICU who required mechanical ventilation for at least 48 hours

Exclusion criteria

Exclusion criteria: Patients with a history of allergic reactions to intravenous magnesium sulfate Patients who need deep sedation (RASS=-4) Patients with any brain damage Patients with myasthenia gravis Patients with chronic renal failure (eGFR less than 30 ml/min) Pregnant and lactating women

Design outcomes

Primary

Measure	Time frame
Cumulative dose of required intravenous opioid. Timepoint: At the end of 24 and 48 hours. Method of measurement: Based on fentanyl dose or equivalent dose of other registered opioids.	—

Secondary

Measure	Time frame
Required adjuvant sedative drugs. Timepoint: At the end of 24 and 48 hours. Method of measurement: Based on the registered drug and cumulative dosage.;Required analgesic drugs. Timepoint: At the end of 24 and 48 hours. Method of measurement: Based on the registered drug and cumulative dosage.;Duration of respiratory support. Timepoint: Daily. Method of measurement: Patient follow-up.;Duration of ICU stay. Timepoint: Daily. Method of measurement: Patient follow-up.;28-day mortality. Timepoint: 28 days after starting the intervention. Method of measurement: Patient follow-up.;Safety of intravenous magnesium sulfate. Timepoint: Continuous monitoring during the study period. Method of measurement: Patient follow-up.;Change in serum CRP level. Timepoint: 48 hours after starting the intervention. Method of measurement: Laboratory data.	—

Measure

Time frame

Required adjuvant sedative drugs. Timepoint: At the end of 24 and 48 hours. Method of measurement: Based on the registered drug and cumulative dosage.;Required analgesic drugs. Timepoint: At the end of 24 and 48 hours. Method of measurement: Based on the registered drug and cumulative dosage.;Duration of respiratory support. Timepoint: Daily. Method of measurement: Patient follow-up.;Duration of ICU stay. Timepoint: Daily. Method of measurement: Patient follow-up.;28-day mortality. Timepoint: 28 days after starting the intervention. Method of measurement: Patient follow-up.;Safety of intravenous magnesium sulfate. Timepoint: Continuous monitoring during the study period. Method of measurement: Patient follow-up.;Change in serum CRP level. Timepoint: 48 hours after starting the intervention. Method of measurement: Laboratory data.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Khalili

Tehran University of Medical Sciences

khalilih@tums.ac.ir+98 21 6695 4715

Outcome results

None listed

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