DeliriumPhase 4NCT02078583
The Effect of Analgesia Based Sedation Protocol on Brain Function of Critical Care Patients
A Phase 4 study testing Fentanyl, Remifentanil and Normal saline in people with Delirium, run by Peking University People's Hospital.
Trial summary
Benzodiazepines is a commonly uesd sedative medication,there are many reports that Benzodiazepines is associated with delirium ,but using of analgesia reduces benzodiazepines requirements .The purpose of this study is to determine whether analgesia based sedation protocol reduces the incident of delirium. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Delirium
- What is being tested?
- Fentanyl, Remifentanil and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jun 2015
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signing a consent form
- postoperative patient
- Requirement for mechanical ventilation and anticipate time of mechanical ventilation more than 24 hours
- Requirement for sedation
- Age more than 18 and less than 85 years old
Who cannot join
- Unstable blood circulation
- Heart rate less than 50 beats per minute
- II ° ～ III ° atrioventricular conduct block
- Intracranial lesions 、neurosurgical intervention and mental disability inability to cooperate;
- Receipt of antipsychotics 、hypnotic drugs before surgery ;
- Alcohol abuse;
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- Liver failure class Child-Pugh C;
- Acute Respiratory Distress Syndrome;
- Acute or chronic renal failure;
- Other severe diseases ,septic shock;
- Receipt of neuromuscular blocking drug;
- Pregnancy and nursing woman;
- Allergy to investigational drug or other contraindication.
Trial locations and contacts
No sites are listed yet.
About this study
Benzodiazepines is a commonly uesd sedative medication,there are many reports that Benzodiazepines is associated with delirium ,but using of analgesia reduces benzodiazepines requirements .The purpose of this study is to determine whether analgesia based sedation protocol reduces the incident of delirium.
- Conditions
- Delirium
- Being tested
- Fentanyl, Remifentanil, Normal saline
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
RemifentanilDrug
Normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil，midazolam | Experimental | Remifentanil 1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02~0.1mg/kg/h continuous intravenous pump for 7days or extubation Receives: Drug: Remifentanil |
| Fentanyl，midazolam | Experimental | Fentanyl 1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02~0.1mg/kg/h continuous intravenous pump for 7days or extubation Receives: Drug: Fentanyl |
| Normal saline | Placebo comparator | Normal saline1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02~0.1mg/kg/h continuous intravenous pump for 7days or extubation Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and duration of delirium in patients with different regimens
Measured: 1 day
Secondary outcomes (9)
Mortality
Measured: 28 days
Ventilator-free days
Measured: an expected average of 7 days
Mean days of mechanical ventilation
Measured: an expected average of 7 days
Length of ICU stay
Measured: an expected average of 7 days
Index of anesthesia depth monitoring
Analgesic level、sedation level、brain function、 blood perfusion for peripheral and brain circulation、sleep stages and variation of blood volume
Measured: From admission to ICU to weaning,about 7 days
Infusion velocity and total dose of sedative drugs in different groups
Measured: From admission to ICU to extubation or drug withdrawal,about 7 days
Plasma melatonin level
Measured: Every 6 hours during the next ICU day
Total rescue dose of midazolam
Measured: Seven days after giving midazolam to patient
Variations of HR、RR、BP、SpO2
Measured: an expected average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078583
- Sponsor's protocol ID
- PEKING SEDATION
- Status last verified
- Jul 2014
- First submitted
- 28 Feb 2014
- Last updated
- 16 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Analgesia Based Sedation Protocol on Brain Function of Critical Care Patients
- ClinicalTrials.gov ID
- NCT02078583
- Acronym / sponsor ID
- PEKING SEDATION
- Conditions
- Delirium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (estimated)
- First posted
- 5 Mar 2014 (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.
Benzodiazepines is a commonly uesd sedative medication,there are many reports that Benzodiazepines is associated with delirium ,but using of analgesia reduces benzodiazepines requirements .The purpose of this study is to determine whether analgesia based sedation protocol reduces the incident of delirium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remifentanil，midazolam | Experimental | Drug: RemifentanilRemifentanil 1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02~0.1mg/kg/h continuous intravenous pump for 7days or extubation |
| Fentanyl，midazolam | Experimental | Drug: FentanylFentanyl 1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02~0.1mg/kg/h continuous intravenous pump for 7days or extubation |
| Normal saline | Placebo comparator | Drug: Normal salineNormal saline1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02~0.1mg/kg/h continuous intravenous pump for 7days or extubation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signing a consent form
- postoperative patient
- Requirement for mechanical ventilation and anticipate time of mechanical ventilation more than 24 hours
- Requirement for sedation
- Age more than 18 and less than 85 years old
Key exclusion criteria (13 listed)
- Unstable blood circulation
- Heart rate less than 50 beats per minute
- II ° ～ III ° atrioventricular conduct block
- Intracranial lesions 、neurosurgical intervention and mental disability inability to cooperate;
- Receipt of antipsychotics 、hypnotic drugs before surgery ;
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 |
|---|---|---|
| Fentanyl | Drug | Fentanyl，midazolam |
| Remifentanil | Drug | Remifentanil，midazolam |
| Normal saline | Drug | Normal saline |
Primary outcome
The incidence and duration of delirium in patients with different regimens
Time frame: 1 day
9 secondary outcomes
Mortality
Time frame: 28 days
Ventilator-free days
Time frame: an expected average of 7 days
Mean days of mechanical ventilation
Time frame: an expected average of 7 days
Length of ICU stay
Time frame: an expected average of 7 days
Index of anesthesia depth monitoring
Time frame: From admission to ICU to weaning,about 7 days
Infusion velocity and total dose of sedative drugs in different groups
Time frame: From admission to ICU to extubation or drug withdrawal,about 7 days
Plasma melatonin level
Time frame: Every 6 hours during the next ICU day
Total rescue dose of midazolam
Time frame: Seven days after giving midazolam to patient
Variations of HR、RR、BP、SpO2
Time frame: an expected average of 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl, Remifentanil and Normal saline in people with Delirium, run by Peking University People's Hospital.
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 5 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 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Dan Liu, Resident physician (+8613811365572, fancyjuice@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and duration of delirium in patients with different regimens (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2014.