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

N/AUnknownNCT05201560

Shanghai Zhongshan Hospital40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Analgesia Hospital-acquired Infections

Interventions

Butorphanol Tartrate InjectionDRUG

Patients of this group will receive Butorphanol Tartrate Injection

FentanylDRUG

Patients of this group will receive Fentanyl

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of hospital-acquired infections

Time frame: one month

Secondary Outcomes

duration on ventilators

patients enrolled will be followed for the duration of mechanical ventilation

Time frame: one month

ICU stay

patients enrolled will be followed for length of ICU stay

Time frame: one month

Hospital stay

patients enrolled will be followed for length of Hospital stay

Time frame: one month

all cause mortality

Time frame: one month

Blood routine examination is assessed by the white blood cell count

Time frame: on the 1st, 3rd，7th day after enrollment

Blood routine examination is assessed by neutrophil count.

Time frame: on the 1st, 3rd，7th day after enrollment

Cytokines

Cytokines are assessed by the interleukin-1,interleukin-6 and interleukin-10

Time frame: on the 1st, 3rd，7th day after enrollment

adverse events

Nausea, vomiting, dry mouth, bradycardia, hypotension, respiratory depression and other adverse events

Time frame: one month

Central Contacts

Wei Wu

CONTACT

13817976707 wu.wei@zs-hospital.sh.cn

Data from ClinicalTrials.gov

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