Clinical trial NCT05201560: Efficacy and Safety of Butorphanol Tartrate Injection for the Patients With Mechanical Ventilation
Official title: Efficacy and Safety of Butorphanol Tartrate Injection for the Patients With Mechanical Ventilation:a Randomized and Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia
Hospital-acquired Infections
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the incidence of hospital-acquired infections between butorphanol and fentanyl.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of hospital-acquired infections
timeFrame: one month
Secondary outcomes:
measure: duration on ventilators
timeFrame: one month
measure: ICU stay
timeFrame: one month
measure: Hospital stay
timeFrame: one month
measure: all cause mortality
timeFrame: one month
measure: Blood routine examination is assessed by the white blood cell count
timeFrame: on the 1st, 3rd，7th day after enrollment
measure: Blood routine examination is assessed by neutrophil count.
timeFrame: on the 1st, 3rd，7th day after enrollment
measure: Cytokines
timeFrame: on the 1st, 3rd，7th day after enrollment
measure: adverse events
timeFrame: one month
Other outcomes:
Locations:
Study officials:
References:
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