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

NCT ID: NCT05201560

Last Updated: 2022-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2023-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Analgesia Hospital-acquired Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Butorphanol tartrate

Butorphanol tartrate on the patients with mechanical ventilation

Group Type EXPERIMENTAL

Butorphanol Tartrate Injection

Intervention Type DRUG

Patients of this group will receive Butorphanol Tartrate Injection

fentanyl

fentanyl on the patients with mechanical ventilation

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

Patients of this group will receive Fentanyl

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Butorphanol Tartrate Injection

Patients of this group will receive Butorphanol Tartrate Injection

Intervention Type DRUG

Fentanyl

Patients of this group will receive Fentanyl

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

the drug of butorphanol tartrate the drug of fentanyl

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wei Wu

Role: CONTACT

13817976707

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 9187957 (View on PubMed)

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.

Reference Type RESULT
PMID: 19952319 (View on PubMed)

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.

Reference Type RESULT
PMID: 12626983 (View on PubMed)

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.

Reference Type RESULT
PMID: 30113379 (View on PubMed)

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.

Reference Type RESULT
PMID: 17625779 (View on PubMed)

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.

Reference Type RESULT
PMID: 30989063 (View on PubMed)

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.

Reference Type RESULT
PMID: 17505683 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SICU-20211026

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Staccato Fentanyl Single and Multidose PK
NCT00402350 COMPLETED PHASE1