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

Fudan University

Status: Unknown

Conditions: Hospital-acquired Infections; Analgesia

Treatments: Drug: Butorphanol Tartrate Injection; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT05201560

SICU-20211026

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Butorphanol tartrate

Experimental group

Description:

Butorphanol tartrate on the patients with mechanical ventilation

Treatment:

Drug: Butorphanol Tartrate Injection

fentanyl

Active Comparator group

Description:

fentanyl on the patients with mechanical ventilation

Treatment:

Drug: Fentanyl