The Effect of Analgesia Based Sedation Protocol on Brain Function of Critical Care Patients
- Registration Number
- NCT02078583
- Lead Sponsor
- Peking University People's Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fentanyl，midazolam Fentanyl 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 Normal saline 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 Remifentanil，midazolam Remifentanil 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
- Primary Outcome Measures
Name Time Method The incidence and duration of delirium in patients with different regimens 1 day
- Secondary Outcome Measures
Name Time Method Mortality 28 days Ventilator-free days an expected average of 7 days Mean days of mechanical ventilation an expected average of 7 days Length of ICU stay an expected average of 7 days Index of anesthesia depth monitoring 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
Infusion velocity and total dose of sedative drugs in different groups From admission to ICU to extubation or drug withdrawal,about 7 days Plasma melatonin level Every 6 hours during the next ICU day Total rescue dose of midazolam Seven days after giving midazolam to patient Variations of HR、RR、BP、SpO2 an expected average of 7 days