- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02078583
The Effect of Analgesia Based Sedation Protocol on Brain Function of Critical Care Patients
July 15, 2014 updated by: Peking University People's Hospital
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dan Liu, Resident physician
- Phone Number: +8613811365572
- Email: fancyjuice@126.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Remifentanil,midazolam
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
|
|
EXPERIMENTAL: Fentanyl,midazolam
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
|
|
PLACEBO_COMPARATOR: Normal saline
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence and duration of delirium in patients with different regimens
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 28 days
|
28 days
|
|
Ventilator-free days
Time Frame: an expected average of 7 days
|
an expected average of 7 days
|
|
Mean days of mechanical ventilation
Time Frame: an expected average of 7 days
|
an expected average of 7 days
|
|
Length of ICU stay
Time Frame: an expected average of 7 days
|
an expected average of 7 days
|
|
Index of anesthesia depth monitoring
Time Frame: From admission to ICU to weaning,about 7 days
|
Analgesic level、sedation level、brain function、 blood perfusion for peripheral and brain circulation、sleep stages and variation of blood volume
|
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
|
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
|
Every 6 hours during the next ICU day
|
|
Total rescue dose of midazolam
Time Frame: Seven days after giving midazolam to patient
|
Seven days after giving midazolam to patient
|
|
Variations of HR、RR、BP、SpO2
Time Frame: an expected average of 7 days
|
an expected average of 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (ANTICIPATED)
June 1, 2015
Study Registration Dates
First Submitted
February 28, 2014
First Submitted That Met QC Criteria
March 4, 2014
First Posted (ESTIMATE)
March 5, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
July 16, 2014
Last Update Submitted That Met QC Criteria
July 15, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Delirium
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Remifentanil
- Fentanyl
Other Study ID Numbers
- PEKING SEDATION
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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