Effect of DrugEOEDSAAIBTNCT06414018
Effect of Equivalent Dose of Alfentanil and Sufentanil in Bronchoscopic Treatment
A study testing Alfentanil in people with Effect of Drug, run by Tongji Hospital at 1 site in China.
Trial summary
The equivalent dose of sufentanil and afentanil combined with laryngeal mask was used for complex bronchoscopy to observe the intraoperative effect and the influence on the recovery of patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Effect of Drug
- What is being tested?
- Alfentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2024to 28 Dec 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80,
- ASA I-III level;
- BMI 18.5~23.9;
Who cannot join
- Patients with full stomach and high risk of reflux aspiration;
- Allergic to benzodiazepines, opioids, rocuronium bromide;
- Those who have taken sedative, analgesic or antidepressant drugs within 24 hours;
- Pregnant and lactating women;
- severe liver and kidney dysfunction;
- Patients with severe anemia and hypoproteinemia;
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- Previous drug use history;
- Recently participated in other clinical studies;
- Patients who cannot cooperate with communication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Equivalent Dose of Alfentanil and Sufentanil Combined With Remimazolam in Complex Bronchoscopic Treatment
The equivalent dose of sufentanil and afentanil combined with laryngeal mask was used for complex bronchoscopy to observe the intraoperative effect and the influence on the recovery of patients
Read the detailed description
Afentanil is a powerful, fast-acting narcotic analgesic, which can effectively inhibit intubation reflex. Compared with sufentanil, it has a short half-life and is safer, and can be used as the first choice for short surgical analgesics. In this study, by comparing the use of equivalent dose sufentanil and afentanil combined with laryngeal mask for complex bronchoscopy, the intraoperative analgesic effect and the influence on the recovery of patients were observed, and a better anesthesia scheme was provided for tracheoscopy.
- Conditions
- Effect of Drug
- Being tested
- Alfentanil
- Keywords
- Afentanil, sufentanil, bronchoscopy, Recovery time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfentanilDrug
Also called sufentanil
alfentanil 10ug/kg is used for anesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil group | Experimental | The dose of sufentanil group is 0.2μg/kg Receives: Drug: Alfentanil |
| Alfentanil | Experimental | The dose of aifentanil group is 10μg/kg Receives: Drug: Alfentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of Recovery
the time from the end of surgery to awake of patient
Measured: 1day
Secondary outcomes (4)
Time records
Anesthesia time, induction time, surgical time, awakening time and recovery time
Measured: 1 day
dose of drugs
The total amount of sedative and analgesic drugs used.
Measured: 1 day
rate of respiratory suppression incidence
Respiratory frequency<8 times/min or SP02<90%
Measured: 1 day
rate of Incidence of Treatment-Emergent Adverse Events
Intraoperative blood pressure and heart rate changes: record the patient's intraoperative blood pressure, heart rate, and the use of related vasoactive drugs; Postoperative adverse reactions: such as hypertension, hypotension, tachycardia, gastrointestinal symptoms, postoperative restlessness, etc
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start20 May 2024
- Primary completion25 Dec 2024
- Study completion28 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- More trials run by Tongji 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xinxiang Central Hospital
- Responsible party
- Principal investigator, aijun xu, Tongji Hospital
- Investigators
- aijun xu, Dr, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414018
- Sponsor's protocol ID
- EEDSA
- Acronym
- EOEDSAAIBT
- Status last verified
- Jan 2025
- First submitted
- 10 May 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: You can request it from the main researcher.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Equivalent Dose of Alfentanil and Sufentanil Combined With Remimazolam in Complex Bronchoscopic Treatment
- ClinicalTrials.gov ID
- NCT06414018
- Acronym / sponsor ID
- EOEDSAAIBT / EEDSA
- Conditions
- Effect of Drug
- Keywords
- Afentanil, sufentanil, bronchoscopy, Recovery time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Xinxiang Central Hospital
- Study start
- 20 May 2024 (actual)
- Primary completion
- 25 Dec 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 14 May 2024 (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 equivalent dose of sufentanil and afentanil combined with laryngeal mask was used for complex bronchoscopy to observe the intraoperative effect and the influence on the recovery of patients
Detailed description
Afentanil is a powerful, fast-acting narcotic analgesic, which can effectively inhibit intubation reflex. Compared with sufentanil, it has a short half-life and is safer, and can be used as the first choice for short surgical analgesics. In this study, by comparing the use of equivalent dose sufentanil and afentanil combined with laryngeal mask for complex bronchoscopy, the intraoperative analgesic effect and the influence on the recovery of patients were observed, and a better anesthesia scheme was provided for tracheoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sufentanil group | Experimental | Drug: AlfentanilThe dose of sufentanil group is 0.2μg/kg |
| Alfentanil | Experimental | Drug: AlfentanilThe dose of aifentanil group is 10μg/kg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80,
- ASA I-III level;
- BMI 18.5~23.9;
Key exclusion criteria (9 listed)
- Patients with full stomach and high risk of reflux aspiration;
- Allergic to benzodiazepines, opioids, rocuronium bromide;
- Those who have taken sedative, analgesic or antidepressant drugs within 24 hours;
- Pregnant and lactating women;
- severe liver and kidney dysfunction;
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 |
|---|---|---|
| AlfentanilAlso: sufentanilalfentanil 10ug/kg is used for anesthesia induction | Drug | Alfentanil, Sufentanil group |
Primary outcome
time of Recovery
Time frame: 1day
the time from the end of surgery to awake of patient
4 secondary outcomes
Time records
Time frame: 1 day
dose of drugs
Time frame: 1 day
rate of respiratory suppression incidence
Time frame: 1 day
rate of Incidence of Treatment-Emergent Adverse Events
Time frame: 1day
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 14 Jan 2025.
- Individual participant dataSharing planned: No. You can request it from the main researcher.
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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.
aijun xu, Dr principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alfentanil in people with Effect of Drug, run by Tongji Hospital 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 3 inclusion and 9 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 14 Jan 2025. 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.
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?
time of Recovery (time frame: 1day). 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 14 Jan 2025.