Fentanyl-induced CoughPhase 1NCT03126422
Effects of Different Doses of Dexmedetomidine on Fentanyl-induced Cough
A Phase 1 study testing Dexmedetomidine in people with Fentanyl-induced Cough, run by Yangzhou University at 1 site in China.
Trial summary
The investigators aimed to investigate the effects of pretreatment with different doses of dexmedetomidine on the cough caused by fentanyl during anesthetic induction. Patients undergoing elective surgeries under general anesthesia will be randomly allocated to 4 groups (n = 60, each group). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fentanyl-induced Cough
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 1 Sep 2017
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing elective surgeries under general anesthesia.
Who cannot join
- Patients with contraindications of dexmedetomidine.
- Patients younger than 18 years old and older than 65 years old.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Affiliated Hospital of Yangzhou University, Yangzhou University
Yangzhou, Jiangsu, 225012
Xinnong Liu, Dr., +8615062791355, zhangzhuanjy@163.com
About this study
The investigators aimed to investigate the effects of pretreatment with different doses of dexmedetomidine on the cough caused by fentanyl during anesthetic induction.
Patients undergoing elective surgeries under general anesthesia will be randomly allocated to 4 groups (n = 60, each group). Dexmedetomidine 0, 0.03, 0.06, and 0.09 μg/kg/min will be pump-administered in 10 mins to groups I, II, III, and IV, respectively, followed by the induction of general anesthesia with intravenous fentanyl 4 μg/kg. The incidences and severity of cough that occurred within 2 min after the injection of fentanyl will be recorded, and the incidences of cardiovascular adverse events that occurred between the administration of the dexmedetomidine infusion and 2 min after tracheal intubation will be recorded.
- Conditions
- Fentanyl-induced Cough
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Pretreatment of different doses of dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine 0 μg/kg/min | Experimental | Not described Receives: Drug: Dexmedetomidine |
| Dexmedetomidine 0.03 μg/kg/min | Experimental | Not described Receives: Drug: Dexmedetomidine |
| Dexmedetomidine 0.06 μg/kg/min | Experimental | Not described Receives: Drug: Dexmedetomidine |
| Dexmedetomidine 0.09 μg/kg/min | Experimental | Not described Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of cough
Yes or No
Measured: After the infusion of dexmedetomidine up to 10 minutes
The time of cough
After the infusion of dexmedetomidine up to 10 minutes
Measured: After the infusion of dexmedetomidine up to 10 minutes
The severity of cough
minor, moderate, severe
Measured: After the infusion of dexmedetomidine up to 10 minutes
The occurence of adverse effects of dexmedetomidine
bradycardia, hypotension, hypertension
Measured: After the infusion of dexmedetomidine up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start1 May 2017
- Primary completion1 Sep 2017 (estimated)
- Study completion1 Sep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fentanyl-induced CoughStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yangzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Zhang, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126422
- Sponsor's protocol ID
- 20170413
- Status last verified
- Jul 2017
- First submitted
- 14 Apr 2017
- Last updated
- 5 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou W, Zhang D, Tian S, Yang Y, Xing Z, Ma R, Zhou T, Bao T, Sun J, Zhang Z. Optimal dose of pretreated-dexmedetomidine in fentanyl-induced cough suppression: a prospective randomized controlled trial. BMC Anesthesiol. 2019 Jun 1;19(1):89. doi: 10.1186/s12871-019-0765-z.
PubMed 31153360
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Doses of Dexmedetomidine on Fentanyl-induced Cough
- ClinicalTrials.gov ID
- NCT03126422
- Acronym / sponsor ID
- 20170413
- Conditions
- Fentanyl-induced Cough
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Yangzhou UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Sep 2017 (estimated)
- Study completion
- 1 Sep 2017 (estimated)
- First posted
- 24 Apr 2017 (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.
The investigators aimed to investigate the effects of pretreatment with different doses of dexmedetomidine on the cough caused by fentanyl during anesthetic induction.
Patients undergoing elective surgeries under general anesthesia will be randomly allocated to 4 groups (n = 60, each group). Dexmedetomidine 0, 0.03, 0.06, and 0.09 μg/kg/min will be pump-administered in 10 mins to groups I, II, III, and IV, respectively, followed by the induction of general anesthesia with intravenous fentanyl 4 μg/kg. The incidences and severity of cough that occurred within 2 min after the injection of fentanyl will be recorded, and the incidences of cardiovascular adverse events that occurred between the administration of the dexmedetomidine infusion and 2 min after tracheal intubation will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine 0 μg/kg/min | Experimental | Drug: Dexmedetomidine |
| Dexmedetomidine 0.03 μg/kg/min | Experimental | Drug: Dexmedetomidine |
| Dexmedetomidine 0.06 μg/kg/min | Experimental | Drug: Dexmedetomidine |
| Dexmedetomidine 0.09 μg/kg/min | Experimental | Drug: Dexmedetomidine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective surgeries under general anesthesia.
Key exclusion criteria (2 listed)
- Patients with contraindications of dexmedetomidine.
- Patients younger than 18 years old and older than 65 years old.
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 |
|---|---|---|
| DexmedetomidinePretreatment of different doses of dexmedetomidine | Drug | Dexmedetomidine 0 μg/kg/min, Dexmedetomidine 0.03 μg/kg/min, Dexmedetomidine 0.06 μg/kg/min, Dexmedetomidine 0.09 μg/kg/min |
Primary outcome
The incidence of cough
Time frame: After the infusion of dexmedetomidine up to 10 minutes
Yes or No
The time of cough
Time frame: After the infusion of dexmedetomidine up to 10 minutes
After the infusion of dexmedetomidine up to 10 minutes
The severity of cough
Time frame: After the infusion of dexmedetomidine up to 10 minutes
minor, moderate, severe
The occurence of adverse effects of dexmedetomidine
Time frame: After the infusion of dexmedetomidine up to 10 minutes
bradycardia, hypotension, hypertension
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Derived from this study: PubMed 31153360Zhou W, Zhang D, Tian S, Yang Y, Xing Z, Ma R, Zhou T, Bao T, Sun J, Zhang Z. Optimal dose of pretreated-dexmedetomidine in fentanyl-induced cough suppression: a prospective randomized controlled trial. BMC Anesthesiol. 2019 Jun 1;19(1):89. doi: 10.1186/s12871-019-0765-z.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexmedetomidine in people with Fentanyl-induced Cough, run by Yangzhou University at 1 site in China.
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 1 inclusion and 2 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 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhuan Zhang, Professor (+8615062791355, zhangzhuanjy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of cough (time frame: After the infusion of dexmedetomidine up to 10 minutes). The study lists 4 primary outcomes in all. 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 NCT03126422, which also lists 1 linked publication.
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 5 Jul 2017.