Sedative Withdrawal Delirium
Conditions
Brief summary
The study was designed to explore the effects of different sedation protocol on incidence rates of delirium and PTSD in severe patients with mechanically ventilation.
Interventions
DRUGDeep sedation(midazolam and fentanyl )
0.05\ 0.1mg/kg midazolam and 1\ 2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1\ 2μg/kg.h fentanyl,continuous intravenous infusion ; the target level of sedation,RASS score between -5 and -3
DRUGDeep and daily interruption of sedation(midazolam and fentanyl )
0.05\ 0.1mg/kg midazolam and 1\ 2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1\ 2μg/kg.h fentanyl continuous intravenous infusion ; The target level of sedation,RASS score between -5 and -3. Daily interruption of sedation will be taken from the second day after admitted in ICU
DRUGLight sedation(midazolam and fentanyl )
0.05\ 0.1mg/kg midazolam and 1\ 2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1\ 2μg/kg.h fentanyl,continuous intravenous infusion ; The target level of sedation,RASS score between -2 and +1;
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Critically ill adults whose expected time of mechanical ventilation is longer than 24 hours * Aged between 18 years old to 85 years old.
Exclusion criteria
* Subjects with brain injury; * History of cardiopulmonary resuscitation; * Mental disability; * Taken neuromuscular blocking drugs; * Inability to exchange; * Contraindicated to midazolam or morphine; * Inconvenience to daily interruption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incident rate of delirium | From weaning to discharged from ICU,about 7 days. |
| The incident rates of PTSD | 30th day and 180th day after discharged from ICU |
| The duration of delirium | From weaning to discharged from ICU,about 7 days. |
Secondary
| Measure | Time frame |
|---|---|
| Duration of ICU | From admitted to ICU to discharged from ICU,about 7 days |
| The whole hospitalization time | From admitted to hospital to discharged from hospital,about 7 days |
| Patients' death rates within ICU stay | From admitted to ICU to discharged from ICU,about 7 days |
| Incidence rate of unexpected extubation | From intubation to weaning,about 7 days |
| The cost in ICU | From admitted to ICU to discharged from ICU,about 7 days |
| The total cost in hospital | From admitted to hospital to discharged from hospital,about 7 days |
| Patients' death rates within hospitalized stay | From admitted to hospital to discharged from hospital,about 7 days |
| Dosage of analgesics and sedatives | From intination of analgesics and sedatives to stopping drug appication,about 7 days |
| The duration of mechanical ventilation | From intubation to weaning,about 7days |
Outcome results
None listed