Failed Conscious Sedation During Procedure
Conditions
Keywords
Pediatric intensive care unit, Sedation, Dexmedetomidine, mechanical ventilation
Brief summary
To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to the pediatric intensive care unit after surgery.
Interventions
DRUGMidazolam
midazolam 3～5μg/kg•min for maintenance of sedation.
DRUGDexmedetomidine
Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；
DRUGFentanyl
Fentanyl 0.5～4 μg/(kg.h) for maintenance of analgesia
OTHERassessment
Ramsay score for sedation assessment, Facial expression, leg movement, activity, cry, and consolability score (FLACC) for analgesia assessment.
Sponsors
Anhui Provincial Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 16 Years
Healthy volunteers
No
Inclusion criteria
1. written informed consent； 2. pediatric patients admitted to intensive care unit after general anesthesia; 3. expected mechanical ventilation time \>6 hours; （4）1 months to 16 years old; -
Exclusion criteria
1. congenital heart disease, arrhythmias and heart failure; 2. Alanine transaminase（ALT） and (or) Aspartate aminotransferase（AST） level is more than twice the upper limit of normal; 3. Creatinine and (or) Blood urea nitrogen（BUN） is more than the upper limit of normal; 4. central nervous system disease; 5. spinal analgesia or muscle relaxants is used during PICU; 6. the drug that affects the nerve conduction is used in one month; 7. allergy to the test drug or having other contraindications; 8. participated in other studies 30 days prior to admission of PICU; -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage of time at target sedation score | up to 24 hours | assess the sedation level every 2 min using Ramsay score |
| the number of patients requiring the sedation remedy | up to 24 hours | the number of patients requiring the sedation remedy during the mechanical ventilation |
| the dosage of midazolam that need for the sedation remedy | up to 24 hours | the dosage of midazolam that need for sedation remedy during the mechanical ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of blood pressure | up to 24 hours. | the change of blood pressure at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used. |
| change of heart rate | up to 24 hours | the change of heart rate at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used. |
| change of respiratory rate | up to 24 hours | the change of respiratory rate at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used. |
| change of blood oxygen saturation | up to 24 hours | the change of blood oxygen saturation at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used. |
| extubation time | up to 24 hours | time from beginning of study drug used to extubation |
| change of hepatic function | up to 24 hours | change of blood ALT、AST level at baseline and 24 hours after the sedation drug used. |
| change of renal function | up to 24 hours | change of blood Cr、BUN level at baseline and 24 hours after the sedation drug used. |
| the dosage of sedation and analgesia drug | up to 24 hours | the total dosage of sedation and analgesia drug during the sedation and analgesia period |
| the number of patients requiring fentanyl analgesia in and after 6 hours from study drug used | up to 24 hours | — |
| the dosage of fentanyl in and after 6 hours from study drug used | up to 24 hours | — |
Outcome results
None listed