Delirium
Conditions
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.
Interventions
DRUGFentanyl
DRUGRemifentanil
DRUGNormal saline
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and duration of delirium in patients with different regimens | 1 day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of ICU stay | an expected average of 7 days | — |
| Mortality | 28 days | — |
| Ventilator-free days | 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 |
| Mean days of mechanical ventilation | an expected average of 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 | — |
| Infusion velocity and total dose of sedative drugs in different groups | From admission to ICU to extubation or drug withdrawal,about 7 days | — |
Contacts
Primary ContactDan Liu, Resident physician
Outcome results
None listed