SufentanilPhase 4NCT03901716
Comparison of Sufentanil, Fentanyl and Remifentanil in Combination With Midazolam During Bronchoscopy Under Conscious Sedation
A Phase 4 study testing Sufentanil, Fentanyl and Remifentanil in people with Sufentanil and Remifentanil, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
The best opioid for bronchoscopy is still unclear.This randomized double-blind prospective study was conducted on a total of 60 patients who were randomly allocated into 3 groups: Group S received sufentanil 0.1 mcg/kg, Group F received fentanyl 1 mcg/kg and Group R received remifentanil target-controlled infusion… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sufentanil, Remifentanil, Fentanyl
- What is being tested?
- Sufentanil, Fentanyl and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2019to 26 Mar 2019
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA grade I-II
Who cannot join
- psychological disorders
- SpO2<90% in ambient air
- hypersensitivity or allergy to anaesthetic drugs or benzodiazepine
- severe chronic obstructive pulmonary disease (forced expiratory volume in 1 s ,50% of predicted value, requirement for oxygen therapy)
- unstable haemodynamic status
- habitual alcohol consumption
- asthmatic patients
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
About this study
Official title: Comparison of Sufentanil, Fentanyl and Remifentanil in Combination With Midazolam During Bronchoscopy Under Conscious Sedation: A Randomized Double-blind Prospective Study
The best opioid for bronchoscopy is still unclear.This randomized double-blind prospective study was conducted on a total of 60 patients who were randomly allocated into 3 groups: Group S received sufentanil 0.1 mcg/kg, Group F received fentanyl 1 mcg/kg and Group R received remifentanil target-controlled infusion with effect-site target concentration of 1ng/ml. Patients in all groups received midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2). Adverse events, patient tolerance and physician satisfaction were analized.
- Conditions
- Sufentanil, Remifentanil, Fentanyl, Bronchoscopy, Narcotrend, Conscious Sedation
- Being tested
- Sufentanil, Fentanyl, Remifentanil, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SufentanilDrug
Patients in Group S received sufentanil 0.1 mcg/kg.
FentanylDrug
Patients in Group F received fentanyl 1 mcg/kg.
RemifentanilDrug
Patients in Group R received remifentanil target-controlled infusion with effect-site target concentration of 1ng/ml.
MidazolamDrug
Patients in all groups received midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2).
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil | Experimental | Group S received sufentanil 0.1 mcg/kg and midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2). Receives: Drug: Sufentanil; Drug: Midazolam |
| Fentanyl | Experimental | Group F received fentanyl 1 mcg/kg and midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2). Receives: Drug: Fentanyl; Drug: Midazolam |
| Remifentanil | Experimental | Group R received remifentanil target-controlled infusion with effect-site target concentration of 1ng/ml and midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2). Receives: Drug: Remifentanil; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of midazolam
Dosage of midazolam applied
Measured: during the procedure
Secondary outcomes (4)
severity of cough
total times of cough
Measured: during the procedure
patient's subjective tolerance
the intensity of four key symptoms during bronchoscopy (pain, nausea, breathlessness and cough) and memory using a visual analogic scale (VAS: 1 mm: excellent tolerance, 100 mm very low tolerance)
Measured: 30minutes after bronchoscopy
patient's global tolerance assessed by operator
the global tolerance of patient to the procedure using a visual analogic scale (VAS: 1 mm: excellent tolerance, 100 mm very low tolerance)
Measured: 30minutes after bronchoscopy
rate of oxygen desaturation
oxygen desaturation (SaO2 decrease<90% for >30 s)
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start15 Jan 2019
- Primary completion15 Mar 2019
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SufentanilStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShiYue Li, Guangzhou Institute of Respiratory Disease
- Investigators
- Shiyue Li, Professor, Study director, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901716
- Sponsor's protocol ID
- Opioid2019
- Status last verified
- Apr 2019
- First submitted
- 30 Mar 2019
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sufentanil, Fentanyl and Remifentanil in Combination With Midazolam During Bronchoscopy Under Conscious Sedation: A Randomized Double-blind Prospective Study
- ClinicalTrials.gov ID
- NCT03901716
- Acronym / sponsor ID
- Opioid2019
- Conditions
- Sufentanil, Remifentanil, Fentanyl, Bronchoscopy, Narcotrend, Conscious Sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 3 Apr 2019 (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 best opioid for bronchoscopy is still unclear.This randomized double-blind prospective study was conducted on a total of 60 patients who were randomly allocated into 3 groups: Group S received sufentanil 0.1 mcg/kg, Group F received fentanyl 1 mcg/kg and Group R received remifentanil target-controlled infusion with effect-site target concentration of 1ng/ml. Patients in all groups received midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2). Adverse events, patient tolerance and physician satisfaction were analized.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sufentanil | Experimental | Drug: Sufentanil, Drug: MidazolamGroup S received sufentanil 0.1 mcg/kg and midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2). |
| Fentanyl | Experimental | Drug: Fentanyl, Drug: MidazolamGroup F received fentanyl 1 mcg/kg and midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2). |
| Remifentanil | Experimental | Drug: Remifentanil, Drug: MidazolamGroup R received remifentanil target-controlled infusion with effect-site target concentration of 1ng/ml and midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA grade I-II
Key exclusion criteria (7 listed)
- psychological disorders
- SpO2<90% in ambient air
- hypersensitivity or allergy to anaesthetic drugs or benzodiazepine
- severe chronic obstructive pulmonary disease (forced expiratory volume in 1 s ,50% of predicted value, requirement for oxygen therapy)
- unstable haemodynamic status
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 |
|---|---|---|
| SufentanilPatients in Group S received sufentanil 0.1 mcg/kg. | Drug | Sufentanil |
| FentanylPatients in Group F received fentanyl 1 mcg/kg. | Drug | Fentanyl |
| RemifentanilPatients in Group R received remifentanil target-controlled infusion with effect-site target concentration of 1ng/ml. | Drug | Remifentanil |
| MidazolamPatients in all groups received midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2). | Drug | Fentanyl, Remifentanil, Sufentanil |
Primary outcome
Dosage of midazolam
Time frame: during the procedure
Dosage of midazolam applied
4 secondary outcomes
severity of cough
Time frame: during the procedure
patient's subjective tolerance
Time frame: 30minutes after bronchoscopy
patient's global tolerance assessed by operator
Time frame: 30minutes after bronchoscopy
rate of oxygen desaturation
Time frame: during the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
Shiyue Li, Professor study director
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sufentanil, Fentanyl and Remifentanil in people with Sufentanil and Remifentanil, run by Guangzhou Institute of Respiratory Disease 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 7 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: finished, as of the sponsor's last update on 3 Apr 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of midazolam (time frame: during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2019.