Mechanical VentilationPhase 4NCT02528513
Midazolam Used Alone or Sequential Use of Midazolam and Propofol/Dexmedetomidine in Mechanically Ventilated Patients
A Phase 4 study testing midazolam, Fentanyl and propofol in people with Mechanical Ventilation and Complication, run by West China Hospital at 1 site in China.
Trial summary
The purpose of this study was to evaluate effects, safety and cost of midazolam used alone or sequential use of midazolam and propofol/dexmedetomidine for long-term sedation in critically ill, mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mechanical Ventilation, Complication, Delirium
- What is being tested?
- midazolam, Fentanyl and propofol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Feb 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intubated patients;
- Age≥18 years old;
- Anticipated Ventilation and sedation duration of at least 72 hours.
Who cannot join
- Allergy to the study drug;
- suspected pregnancy;
- gross obesity;
- Extremely unstable of circulatory system, such as systolic blood pressure less than 90 mm Hg despite plasma volume expansion and continuous infusions of vasopressors before the start of study drug infusion;
- Uncontrolled abnormal hypertension, such as systolic blood pressure more than 180 mmHg or diastolic more than105 mmHg;
- Heart rate less than 50 bpm;
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- Second or third degree heart block;
- moribund state;
- history of alcoholism or intake of anti-anxiety drugs or hypnotics;
- chronic renal failure;
- coma by cranial trauma or neurosurgery or unknown etiology or epileptic state;
- History of neuromuscular disease;
- unwillingness to provide informed consent by patients or their authorized surrogates following ICU admission.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical care medicine of West China Hospital
Chengdu, Sichuan, 610041
About this study
Official title: Midazolam Used Alone or Sequential Use of Midazolam and Propofol/Dexmedetomidine for Long-Term Sedation in Critically Ill, Mechanically Ventilated Patients: a Prospective, Randomized Study
The purpose of this study was to evaluate effects, safety and cost of midazolam used alone or sequential use of midazolam and propofol/dexmedetomidine for long-term sedation in critically ill, mechanically ventilated patients.
Read the detailed description
It is well known that sedation is frequently required as a component of compassionate care in critically ill patients. Until now, there is no ideal sedation drug and every sedation drug has its advantage and disadvantage for long-term sedation in critically ill, mechanically ventilated patients. The sequential use of midazolam and propofol for long-term sedation was associated with a faster recovery, earlier extubation, shorter mechanical ventilation time and less cost of total ICU treatment compared with midazolam alone, The protocol was associated with less cost of pharmaceutical sedation compared with propofol alone. But, propofol and midazolam may cause respiratory depression and delirium. Both drugs should be stopped after the patient passed the screen of weaning from mechanical ventilation, then it would induce the stress response and agitation, it would cause prolonged sedation and delay extubation.
Dexmedetomidine is a centrally acting a2-receptor agonist, has less effect on arousability and respiratory depression. The purpose of this study was to evaluate effects, safety and cost of midazolam used alone or sequential use of midazolam and propofol/dexmedetomidine for long-term sedation in critically ill, mechanically ventilated patients.
- Conditions
- Mechanical Ventilation, Complication, Delirium
- Being tested
- midazolam, Fentanyl, propofol, Dexmedetomidine, Procedure:sedation assessment
- Keywords
- sedation, Midazolam, Propofol, Dexmedetomidine
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolamDrug
Also called Liyuxi
Midazolam is started with an infusion bolus of 0.03-0.30 mg/kg and continuous infusion of 0.03-0.20 mg/kg/h, with the dosage adjusted to RASS score (-3 to 0).
FentanylDrug
Fentanyl is used with bolus dosage of 1-2ug/kg and maintenance dosage of 1-2ug/kg/h, with the dosage adjusted to critical care pain observation tool（CPOT）score(0-1).
propofolDrug
After the spontaneous breathing trial safety screen is passed, midazolam is switched to propofol, which is administered at the maintenance dosage of 0.50-3.00mg/kg/h, with the dosage adjusted to RASS score (-2 to 0).
DexmedetomidineDrug
After the spontaneous breathing trial safety screen is passed, midazolam is switched to dexmedetomidine, which is administered at an infusion bolus of 0.5μg/kg over 10 min (given or not according to patients' condition) and the maintenance dosage of 0.2-0.7ug/kg/h, with the dosage adjusted to RASS score (-2 to 0).
Procedure:sedation assessmentProcedure or surgery
The nursing staff continuously monitored the sedation depth and adjusted the dosages of sedative and analgesic drugs to maintain the sedation target level. The sedation depth were assessed and recorded every 4 h (or more frequently when indicated).
Procedure:WeaningProcedure or surgery
the respiratory therapists managed patients with a daily interruption of continuous sedation and the spontaneous breathing trial (SBT) protocols daily.
midazolam(used for passing the SBT safety screen)Drug
Also called Liyuxi
After the spontaneous breathing trial safety screen is passed,in the midazolam group, midazolam will continue to be used for sedation, with the dosage adjusted to RASS score (-2 to 0).
| Study group | Role | What they receive |
|---|---|---|
| midazolam | Experimental | 1. Midazolam is started with an infusion bolus of 0.03-0.30 mg/kg and continuous infusion of 0.03-0.20 mg/kg/h, with the dosage adjusted to achieve the desired level of sedation.
2. After the spontaneous breathing trial safety screen is passed, midazolam will continue to be used for sedation, with the dosage adjusted to achieve the desired level of sedation. Receives: Drug: midazolam; Drug: Fentanyl; Procedure: Procedure:sedation assessment; Procedure: Procedure:Weaning; Drug: midazolam(used for passing the SBT safety screen) |
| midazolam/propofol | Experimental | 1. Midazolam is started with an infusion bolus of 0.03-0.30 mg/kg and continuous infusion of 0.03-0.20 mg/kg/h, with the dosage adjusted to achieve the desired level of sedation.
2. After the spontaneous breathing trial safety screen is passed, midazolam is switched to propofol, which is administered at the maintenance dosage of 0.50-3.00mg/kg/h, with the dosage adjusted to achieve the desired level of sedation. Receives: Drug: midazolam; Drug: Fentanyl; Drug: propofol; Procedure: Procedure:sedation assessment; Procedure: Procedure:Weaning |
| midazolam/dexmedetomidine | Experimental | 1. Midazolam is started with an infusion bolus of 0.03-0.30 mg/kg and continuous infusion of 0.03-0.20 mg/kg/h, with the dosage adjusted to achieve the desired level of sedation.
2. After the spontaneous breathing trial safety screen is passed, midazolam is switched to dexmedetomidine, which is administered at an infusion bolus of 0.5 μg/kg over 10 min (given or not according to patients' condition) and the maintenance dosage of 0.2-0.7ug/kg/h, with the dosage adjusted to achieve the desired level of sedation. Receives: Drug: midazolam; Drug: Fentanyl; Drug: Dexmedetomidine; Procedure: Procedure:sedation assessment; Procedure: Procedure:Weaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning time
Measured: From sedation sequential criteria to extubation, up to 28 days
Secondary outcomes (4)
The pharmaceutical costs of sedation
Measured: From sedation drug is used to cessation of sedation up to 28 days.
The total ICU costs
Measured: From admitted to ICU until ventilation and participants discharged from ICU, up to 28 days.
The incidence of delirium (patients with diagnosis of delirium/ total patients in each group × 100% )
After the daily interruption of continuous sedation,delirium is assessed by the the confusion assessment method for the diagnosis of delirium in ICU(CAM-ICU). If the patient has the clinical features of 1 and 2, or 3,or 4 in the CAM-ICU, delirium can be diagnosed.
Measured: From sedation drug is used to cessation of sedation, up to 28 days.
Sedation satisfaction degree (The total time within target sedation level/total evaluation times ×100% )
Measured: From sedation drug is used to cessation of sedation up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Yongfang, West China Hospital
- Investigators
- Y Kang, Dr, Study chair, Critical Medicine Department,West China Hospital of Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528513
- Sponsor's protocol ID
- HaxiICU
- Status last verified
- Apr 2016
- First submitted
- 15 Aug 2015
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhou Y, Yang J, Wang B, Wang P, Wang Z, Yang Y, Liang G, Jing X, Jin X, Zhang Z, Deng Y, Hu C, Liao X, Yin W, Tang Z, Tian Y, Tao L, Kang Y. Sequential use of midazolam and dexmedetomidine for long-term sedation may reduce weaning time in selected critically ill, mechanically ventilated patients: a randomized controlled study. Crit Care. 2022 May 3;26(1):122. doi: 10.1186/s13054-022-03967-5.
PubMed 35505432
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midazolam Used Alone or Sequential Use of Midazolam and Propofol/Dexmedetomidine for Long-Term Sedation in Critically Ill, Mechanically Ventilated Patients: a Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT02528513
- Acronym / sponsor ID
- HaxiICU
- Conditions
- Mechanical Ventilation, Complication, Delirium
- Keywords
- sedation, Midazolam, Propofol, Dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate effects, safety and cost of midazolam used alone or sequential use of midazolam and propofol/dexmedetomidine for long-term sedation in critically ill, mechanically ventilated patients.
Detailed description
It is well known that sedation is frequently required as a component of compassionate care in critically ill patients. Until now, there is no ideal sedation drug and every sedation drug has its advantage and disadvantage for long-term sedation in critically ill, mechanically ventilated patients. The sequential use of midazolam and propofol for long-term sedation was associated with a faster recovery, earlier extubation, shorter mechanical ventilation time and less cost of total ICU treatment compared with midazolam alone, The protocol was associated with less cost of pharmaceutical sedation compared with propofol alone. But, propofol and midazolam may cause respiratory depression and delirium. Both drugs should be stopped after the patient passed the screen of weaning from mechanical ventilation, then it would induce the stress response and agitation, it would cause prolonged sedation and delay extubation.
Dexmedetomidine is a centrally acting a2-receptor agonist, has less effect on arousability and respiratory depression. The purpose of this study was to evaluate effects, safety and cost of midazolam used alone or sequential use of midazolam and propofol/dexmedetomidine for long-term sedation in critically ill, mechanically ventilated patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| midazolam | Experimental | Drug: midazolam, Drug: Fentanyl, Procedure: Procedure:sedation assessment, Procedure: Procedure:Weaning, Drug: midazolam(used for passing the SBT safety screen)1. Midazolam is started with an infusion bolus of 0.03-0.30 mg/kg and continuous infusion of 0.03-0.20 mg/kg/h, with the dosage adjusted to achieve the desired level of sedation. 2. After the spontaneous breathing trial safety screen is passed, midazolam will continue to be used for sedation, with the dosage adjusted to achieve the desired level of sedation. |
| midazolam/propofol | Experimental | Drug: midazolam, Drug: Fentanyl, Drug: propofol, Procedure: Procedure:sedation assessment, Procedure: Procedure:Weaning1. Midazolam is started with an infusion bolus of 0.03-0.30 mg/kg and continuous infusion of 0.03-0.20 mg/kg/h, with the dosage adjusted to achieve the desired level of sedation. 2. After the spontaneous breathing trial safety screen is passed, midazolam is switched to propofol, which is administered at the maintenance dosage of 0.50-3.00mg/kg/h, with the dosage adjusted to achieve the desired level of sedation. |
| midazolam/dexmedetomidine | Experimental | Drug: midazolam, Drug: Fentanyl, Drug: Dexmedetomidine, Procedure: Procedure:sedation assessment, Procedure: Procedure:Weaning1. Midazolam is started with an infusion bolus of 0.03-0.30 mg/kg and continuous infusion of 0.03-0.20 mg/kg/h, with the dosage adjusted to achieve the desired level of sedation. 2. After the spontaneous breathing trial safety screen is passed, midazolam is switched to dexmedetomidine, which is administered at an infusion bolus of 0.5 μg/kg over 10 min (given or not according to patients' condition) and the maintenance dosage of 0.2-0.7ug/kg/h, with the dosage adjusted to achieve the desired level of sedation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Intubated patients;
- Age≥18 years old;
- Anticipated Ventilation and sedation duration of at least 72 hours.
Key exclusion criteria (13 listed)
- Allergy to the study drug;
- suspected pregnancy;
- gross obesity;
- Extremely unstable of circulatory system, such as systolic blood pressure less than 90 mm Hg despite plasma volume expansion and continuous infusions of vasopressors before the start of study drug infusion;
- Uncontrolled abnormal hypertension, such as systolic blood pressure more than 180 mmHg or diastolic more than105 mmHg;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| midazolamAlso: LiyuxiMidazolam is started with an infusion bolus of 0.03-0.30 mg/kg and continuous infusion of 0.03-0.20 mg/kg/h, with the dosage adjusted to RASS score (-3 to 0). | Drug | midazolam, midazolam/dexmedetomidine, midazolam/propofol |
| FentanylFentanyl is used with bolus dosage of 1-2ug/kg and maintenance dosage of 1-2ug/kg/h, with the dosage adjusted to critical care pain observation tool（CPOT）score(0-1). | Drug | midazolam, midazolam/dexmedetomidine, midazolam/propofol |
| propofolAfter the spontaneous breathing trial safety screen is passed, midazolam is switched to propofol, which is administered at the maintenance dosage of 0.50-3.00mg/kg/h, with the dosage adjusted to RASS score (-2 to 0). | Drug | midazolam/propofol |
| DexmedetomidineAfter the spontaneous breathing trial safety screen is passed, midazolam is switched to dexmedetomidine, which is administered at an infusion bolus of 0.5μg/kg over 10 min (given or not according to patients' condition) and the maintenance dosage of 0.2-0.7ug/kg/h, with the dosage adjusted to RASS score (-2 to 0). | Drug | midazolam/dexmedetomidine |
| Procedure:sedation assessmentThe nursing staff continuously monitored the sedation depth and adjusted the dosages of sedative and analgesic drugs to maintain the sedation target level. The sedation depth were assessed and recorded every 4 h (or more frequently when indicated). | Procedure or surgery | midazolam, midazolam/dexmedetomidine, midazolam/propofol |
| Procedure:Weaningthe respiratory therapists managed patients with a daily interruption of continuous sedation and the spontaneous breathing trial (SBT) protocols daily. | Procedure or surgery | midazolam, midazolam/dexmedetomidine, midazolam/propofol |
| midazolam(used for passing the SBT safety screen)Also: LiyuxiAfter the spontaneous breathing trial safety screen is passed,in the midazolam group, midazolam will continue to be used for sedation, with the dosage adjusted to RASS score (-2 to 0). | Drug | midazolam |
Primary outcome
Weaning time
Time frame: From sedation sequential criteria to extubation, up to 28 days
4 secondary outcomes
The pharmaceutical costs of sedation
Time frame: From sedation drug is used to cessation of sedation up to 28 days.
The total ICU costs
Time frame: From admitted to ICU until ventilation and participants discharged from ICU, up to 28 days.
The incidence of delirium (patients with diagnosis of delirium/ total patients in each group × 100% )
Time frame: From sedation drug is used to cessation of sedation, up to 28 days.
Sedation satisfaction degree (The total time within target sedation level/total evaluation times ×100% )
Time frame: From sedation drug is used to cessation of sedation up to 28 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Derived from this study: PubMed 35505432Zhou Y, Yang J, Wang B, Wang P, Wang Z, Yang Y, Liang G, Jing X, Jin X, Zhang Z, Deng Y, Hu C, Liao X, Yin W, Tang Z, Tian Y, Tao L, Kang Y. Sequential use of midazolam and dexmedetomidine for long-term sedation may reduce weaning time in selected critically ill, mechanically ventilated patients: a randomized controlled study. Crit Care. 2022 May 3;26(1):122. doi: 10.1186/s13054-022-03967-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Y Kang, Dr study chair
Critical Medicine Department,West China Hospital of Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing midazolam, Fentanyl and propofol in people with Mechanical Ventilation and Complication, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weaning time (time frame: From sedation sequential criteria to extubation, up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02528513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2016.