Efficacy and Safety of Butorphanol Tartrate Injection for the Patients With Mechanical Ventilation

Study Overview
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Brief Summary
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To compare the incidence of hospital-acquired infections between butorphanol and fentanyl.

Detailed Description
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Butorphanol can improve inflammation and promote the recovery of pro-inflammatory/anti-inflammatory cytokine balance.However, there is still a lack of relevant clinical studies on butorphanol and fentanyl for the incidence of hospital-acquired infections in ICU mechanically ventilated patients.The objective of this study was to evaluate the analgesic efficacy,safety and the incidence of nosocomial infection of butorphanol in mechanical ventilation patients between butorphanol and fentanyl.

Official Title
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Efficacy and Safety of Butorphanol Tartrate Injection for the Patients With Mechanical Ventilation:a Randomized and Controlled Trial

Conditions
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Analgesia, Hospital-acquired Infections

Intervention / Treatment
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* Drug: Butorphanol Tartrate Injection
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: need mechanical ventilation for more than 48 hours more than 18 years old without hospital-acquired infection before admission to ICU volunteer to participate in this study Exclusion Criteria: allergic or contraindicated to the drug severe cardiac insufficiency, conduction block and bradycardia recent use of analgesic, sedative and antidepressant drugs psychiatric or neurological diseases or neurosurgery-related diseases history of steroid cortisol and immunosuppressants severe liver dysfunction or renal dysfunction pregnancy refuse to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Butorphanol tartrate<br>Butorphanol tartrate on the patients with mechanical ventilation | Drug: Butorphanol Tartrate Injection<br>* Patients of this group will receive Butorphanol Tartrate Injection<br>* Other names: the drug of butorphanol tartrate;|
| Active Comparator: fentanyl<br>fentanyl on the patients with mechanical ventilation | Drug: Fentanyl<br>* Patients of this group will receive Fentanyl<br>* Other names: the drug of fentanyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hospital-acquired infections | Incidence of hospital-acquired infections | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration on ventilators | patients enrolled will be followed for the duration of mechanical ventilation | one month | 
| ICU stay | patients enrolled will be followed for length of ICU stay | one month | 
| Hospital stay | patients enrolled will be followed for length of Hospital stay | one month | 
| all cause mortality | all cause mortality | one month | 
| Blood routine examination is assessed by the white blood cell count |  | on the 1st, 3rd，7th day after enrollment | 
| Blood routine examination is assessed by neutrophil count. |  | on the 1st, 3rd，7th day after enrollment | 
| Cytokines | Cytokines are assessed by the interleukin-1,interleukin-6 and interleukin-10 | on the 1st, 3rd，7th day after enrollment | 
| adverse events | Nausea, vomiting, dry mouth, bradycardia, hypotension, respiratory depression and other adverse events | one month |