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

Not Applicable

• Conditions: Hospital-acquired Infections; Analgesia
• Interventions: Drug: Butorphanol Tartrate Injection; Drug: Fentanyl

• Registration Number: NCT05201560
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study First Submitted: 2021-10-29
• Status Verified: 2022-01
• Study Start: 2022-01
• Study First Submitted QC: 2022-01-20
• Last Update Submitted: 2022-01-20
• Study First Posted: 2022-01-21
• Last Update Posted: 2022-01-21
• Primary Completion: 2023-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Butorphanol tartrate	Butorphanol Tartrate Injection	Butorphanol tartrate on the patients with mechanical ventilation
fentanyl	Fentanyl	fentanyl on the patients with mechanical ventilation

Primary Outcome Measures

Name	Time	Method
Incidence of hospital-acquired infections	one month	Incidence of hospital-acquired infections

Secondary Outcome Measures

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