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

NCT05201560 | Unknown

• 1 other identifier: SICU-20211026
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Analgesia; Hospital-acquired Infections

Outcome Measures

Primary Outcomes (1)

• Incidence of hospital-acquired infections

  Incidence of hospital-acquired infections

  one month

Secondary Outcomes (8)

• duration on ventilators

  one month

• ICU stay

  one month

• Hospital stay

  one month

• all cause mortality

  one month

• Blood routine examination is assessed by the white blood cell count

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

Study Arms (2)

Butorphanol tartrate

EXPERIMENTAL

Butorphanol tartrate on the patients with mechanical ventilation

Drug: Butorphanol Tartrate Injection

fentanyl

ACTIVE COMPARATOR

fentanyl on the patients with mechanical ventilation

Drug: Fentanyl

Interventions

Butorphanol Tartrate Injection DRUG

Patients of this group will receive Butorphanol Tartrate Injection

Also known as: the drug of butorphanol tartrate

Butorphanol tartrate

Fentanyl DRUG

Patients of this group will receive Fentanyl

Also known as: the drug of fentanyl

fentanyl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Related Publications (7)

• 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. doi: 10.1016/s0891-5520(05)70366-4.

  PMID: 9187957 RESULT

• 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;302(21):2323-9. doi: 10.1001/jama.2009.1754.

  PMID: 19952319 RESULT

• 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. doi: 10.1097/01.CCM.0000053652.80849.9F.

  PMID: 12626983 RESULT

• Devlin JW, Skrobik Y, Gelinas 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 JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.

  PMID: 30113379 RESULT

• Giamberardino HI, Cesario EP, Carmes ER, Mulinari RA. Risk factors for nosocomial infection in trauma patients. Braz J Infect Dis. 2007 Apr;11(2):285-9. doi: 10.1590/s1413-86702007000200024.

  PMID: 17625779 RESULT

• 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.

  PMID: 30989063 RESULT

• 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 Med J. 2007 Jan 4;125(1):34-41. doi: 10.1590/s1516-31802007000100007.

  PMID: 17505683 RESULT

MeSH Terms

Conditions

Agnosia

Interventions

Butorphanol; Fentanyl

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Wei Wu

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: January 21, 2022
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share