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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05201560

Enrollment

Registered

2022-01-21

Start date

2022-01-31

Completion date

2023-01-31

Last updated

2022-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Hospital-acquired Infections

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.

Interventions

DRUGButorphanol Tartrate Injection

Patients of this group will receive Butorphanol Tartrate Injection

DRUGFentanyl

Patients of this group will receive Fentanyl

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of hospital-acquired infections	one month	Incidence of hospital-acquired infections

Secondary

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

Contacts

Primary ContactWei Wu

wu.wei@zs-hospital.sh.cn13817976707

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026