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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05201560
• Other study ID #: SICU-20211026
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2022
• Est. completion date: January 2023

Study information

• Verified date: January 2022
• Source: Shanghai Zhongshan Hospital
• Contact: Wei Wu
• Phone: 13817976707
• Email: wu.wei[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Hospital-acquired Infections

Intervention

Drug:
• Butorphanol Tartrate Injection
Patients of this group will receive Butorphanol Tartrate Injection
• Fentanyl
Patients of this group will receive Fentanyl

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

References & Publications (7)

Aguilar-Nascimento JE, Marra JG, Slhessarenko N, Fontes CJ. Efficacy of National Nosocomial Infection Surveillance score, acute-phase proteins, and interleukin-6 for predicting postoperative infections following major gastrointestinal surgery. Sao Paulo M — View Citation

Baviskar AS, Khatib KI, Rajpal D, Dongare HC. Nosocomial infections in surgical intensive care unit: A retrospective single-center study. Int J Crit Illn Inj Sci. 2019 Jan-Mar;9(1):16-20. doi: 10.4103/IJCIIS.IJCIIS_57_18. — View Citation

Devlin JW, Skrobik Y, Gélinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress — View Citation

Fridkin SK, Welbel SF, Weinstein RA. Magnitude and prevention of nosocomial infections in the intensive care unit. Infect Dis Clin North Am. 1997 Jun;11(2):479-96. Review. — View Citation

Giamberardino HI, Cesário EP, Carmes ER, Mulinari RA. Risk factors for nosocomial infection in trauma patients. Braz J Infect Dis. 2007 Apr;11(2):285-9. — View Citation

Meissner W, Dohrn B, Reinhart K. Enteral naloxone reduces gastric tube reflux and frequency of pneumonia in critical care patients during opioid analgesia. Crit Care Med. 2003 Mar;31(3):776-80. — View Citation

Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2; — View Citation

Outcome

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