AnalgesiaNCT05201560
Efficacy and Safety of Butorphanol Tartrate Injection for the Patients With Mechanical Ventilation
A study testing Butorphanol Tartrate Injection and Fentanyl in people with Analgesia and Hospital-acquired Infections, run by Shanghai Zhongshan Hospital.
Trial summary
To compare the incidence of hospital-acquired infections between butorphanol and fentanyl. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia, Hospital-acquired Infections
- What is being tested?
- Butorphanol Tartrate Injection and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Butorphanol Tartrate Injection for the Patients With Mechanical Ventilation:a Randomized and Controlled Trial
To compare the incidence of hospital-acquired infections between butorphanol and fentanyl.
Read the 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.
- Conditions
- Analgesia, Hospital-acquired Infections
- Being tested
- Butorphanol Tartrate Injection, Fentanyl
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butorphanol Tartrate InjectionDrug
Also called the drug of butorphanol tartrate
Patients of this group will receive Butorphanol Tartrate Injection
FentanylDrug
Also called the drug of fentanyl
Patients of this group will receive Fentanyl
| Study group | Role | What they receive |
|---|---|---|
| Butorphanol tartrate | Experimental | Butorphanol tartrate on the patients with mechanical ventilation Receives: Drug: Butorphanol Tartrate Injection |
| fentanyl | Active comparator | fentanyl on the patients with mechanical ventilation Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hospital-acquired infections
Incidence of hospital-acquired infections
Measured: one month
Secondary outcomes (8)
duration on ventilators
patients enrolled will be followed for the duration of mechanical ventilation
Measured: one month
ICU stay
patients enrolled will be followed for length of ICU stay
Measured: one month
Hospital stay
patients enrolled will be followed for length of Hospital stay
Measured: one month
all cause mortality
all cause mortality
Measured: one month
Blood routine examination is assessed by the white blood cell count
Measured: on the 1st, 3rd，7th day after enrollment
Blood routine examination is assessed by neutrophil count.
Measured: on the 1st, 3rd，7th day after enrollment
Cytokines
Cytokines are assessed by the interleukin-1,interleukin-6 and interleukin-10
Measured: on the 1st, 3rd，7th day after enrollment
adverse events
Nausea, vomiting, dry mouth, bradycardia, hypotension, respiratory depression and other adverse events
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201560
- Sponsor's protocol ID
- SICU-20211026
- Status last verified
- Jan 2022
- First submitted
- 29 Oct 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9187957Vincent 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.
PubMed 19952319Meissner 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.
PubMed 12626983Devlin 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.
PubMed 30113379Giamberardino 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.
PubMed 17625779Baviskar 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.
PubMed 30989063Aguilar-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.
PubMed 17505683
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Butorphanol Tartrate Injection for the Patients With Mechanical Ventilation:a Randomized and Controlled Trial
- ClinicalTrials.gov ID
- NCT05201560
- Acronym / sponsor ID
- SICU-20211026
- Conditions
- Analgesia, Hospital-acquired Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Butorphanol tartrate | Experimental | Drug: Butorphanol Tartrate InjectionButorphanol tartrate on the patients with mechanical ventilation |
| fentanyl | Active comparator | Drug: Fentanylfentanyl on the patients with mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Butorphanol Tartrate InjectionAlso: the drug of butorphanol tartratePatients of this group will receive Butorphanol Tartrate Injection | Drug | Butorphanol tartrate |
| FentanylAlso: the drug of fentanylPatients of this group will receive Fentanyl | Drug | fentanyl |
Primary outcome
Incidence of hospital-acquired infections
Time frame: one month
Incidence of hospital-acquired infections
8 secondary outcomes
duration on ventilators
Time frame: one month
ICU stay
Time frame: one month
Hospital stay
Time frame: one month
all cause mortality
Time frame: one month
Blood routine examination is assessed by the white blood cell count
Time frame: on the 1st, 3rd，7th day after enrollment
Blood routine examination is assessed by neutrophil count.
Time frame: on the 1st, 3rd，7th day after enrollment
Cytokines
Time frame: on the 1st, 3rd，7th day after enrollment
adverse events
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Results publication: PubMed 9187957Fridkin 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.
- Results publication: PubMed 19952319Vincent 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.
- Results publication: PubMed 12626983Meissner 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.
- Results publication: PubMed 30113379Devlin 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.
- Results publication: PubMed 17625779Giamberardino 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.
- Results publication: PubMed 30989063Baviskar 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.
- Results publication: PubMed 17505683Aguilar-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Butorphanol Tartrate Injection and Fentanyl in people with Analgesia and Hospital-acquired Infections, run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Wu (13817976707, wu.wei@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hospital-acquired infections (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05201560, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.