Midazolam, propofol used alone or sequentially for long-term sedation in critically ill, mechanically ventilated patients

Midazolam, propofol used alone or sequentially for long-term sedation in critically ill, mechanically ventilated patients: a prospective, randomized study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN01173443

Enrollment

105

Registered

2014-03-03

Start date

2010-03-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Mechanical ventilation Not Applicable

Interventions

All the patients received continuous intravenous fentanyl for analgesia with bolus dosage of 1-2 ug/kg and maintenance dosage of 1-2 ug/kg/h. Patients allocated to the midazolam group (group M) were t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Intubated patients (>18 years old) who were expected to receive long-term (>3 days) mechanical ventilation on admission to the ICU within West China Hospital of Sichuan University between March 2009 and September 2011

Exclusion criteria

Exclusion criteria: 1. Known or suspected allergy to propofol or midazolam 2. Suspected pregnancy 3. Gross obesity 4. Hyperlipemia 5. Moribund state 6. History of alcoholism or intake of anti-anxiety drugs or hypnotics 7. Chronic renal failure 8. Coma by cranial trauma or neurosurgery or unknown etiology or status epilepticus 9. Unwillingness to provide informed consent by patients or their authorized surrogates following ICU admission

Design outcomes

Primary

Measure	Time frame
To determine the recovery and extubation time, which were defined as the time from the cessation of sedation until awakening and extubation	—

Secondary

Measure	Time frame
To determine the cost of sedation, the primary monetary pharmaceutical costs of sedation and total ICU costs (including ICU therapy and sedation) were calculated. After patients were transferred out of ICU, their recollection of mechanical ventilation-related events (rolling over, suction, and endotracheal tube stimulation and pain) were recorded using a questionnaire. The patients responded from the following options: (A) unbearable memory, (B) bearable memory, and (C) no memory.	—

Measure

Time frame

To determine the cost of sedation, the primary monetary pharmaceutical costs of sedation and total ICU costs (including ICU therapy and sedation) were calculated. After patients were transferred out of ICU, their recollection of mechanical ventilation-related events (rolling over, suction, and endotracheal tube stimulation and pain) were recorded using a questionnaire. The patients responded from the following options: (A) unbearable memory, (B) bearable memory, and (C) no memory.

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Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026