Pediatric AnesthesiaPhase 4NCT07581665
Effective Dose of Alfentanil Combined With Propofol for Laryngeal Mask Airway Insertion in Children
A Phase 4 study testing Alfentanil in people with Pediatric Anesthesia and Airway Management, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
This study uses a prospective, up-and-down sequential allocation method to determine the median effective dose (ED50) and 95% effective dose (ED95) of alfentanil combined with propofol for successful laryngeal mask airway (LMA) insertion in children aged 7-12 undergoing elective day surgery. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Pediatric Anesthesia, Airway Management, General Anesthesia
- What is being tested?
- Alfentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2026to 11 Jul 2026
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 7 to 12 years
- Undergoing elective day surgery
- ASA physical status I-II
- Body Mass Index (BMI) between 14 and 24 kg/m²
- Accompanied by a fully capable guardian within 24 hours after discharge
Who cannot join
- Allergy to opioids
- Unresolved upper respiratory tract infection within the past 1 week
- Abnormal heart, lung, liver, or kidney function, or metabolic diseases
- Airway anatomical abnormalities (e.g., micrognathia, laryngomalacia, macroglossia) or OSAHS (Obstructive Sleep Apnea-Hypopnea Syndrome)
- Use of analgesics, sedatives, or other psychotropic drugs within the past 2 weeks
- Refusal to sign the informed consent form
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
Official title: Effective Dose of Alfentanil Combined With Propofol for Laryngeal Mask Airway Insertion in Children: A Prospective, Up-and-Down Sequential Allocation Study
This study uses a prospective, up-and-down sequential allocation method to determine the median effective dose (ED50) and 95% effective dose (ED95) of alfentanil combined with propofol for successful laryngeal mask airway (LMA) insertion in children aged 7-12 undergoing elective day surgery.
Read the detailed description
Laryngeal mask airway (LMA) insertion is a common practice in pediatric day surgery. While it is less invasive than endotracheal intubation, children exhibit high airway reactivity, requiring an optimal depth of anesthesia to suppress airway reflexes. Alfentanil is an opioid with a rapid onset and short duration of action, making it potentially ideal for LMA insertion. However, current dosage recommendations for alfentanil are often extrapolated from tracheal intubation studies, which may lead to overdosage, respiratory depression, or delayed recovery in children. This study aims to determine the precise effective dose (ED50 and ED95) of alfentanil when combined with a fixed dose of propofol for smooth LMA insertion in children.
- Conditions
- Pediatric Anesthesia, Airway Management, General Anesthesia, LMA
- Being tested
- Alfentanil
- Keywords
- Alfentanil, Propofol, Pediatric Anesthesia, LMA, Dixon Method, Effective dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfentanilDrug
All patients receive 2.5 mg/kg propofol injected over 30 seconds. Alfentanil is administered 1 minute prior to propofol. The dose is adjusted by steps of 2 µg/kg based on the previous patient's response (successful insertion = decrease dose; failed insertion = increase dose).
| Study group | Role | What they receive |
|---|---|---|
| Alfentanil Sequential Dose Group | Experimental | Not described Receives: Drug: Alfentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of LMA insertion
Assessed by the absence of body movement, coughing, breath-holding, severe hemodynamic changes, or insertion difficulty.
Measured: Intraoperative (During LMA insertion procedure)
Secondary outcomes (8)
Time required for LMA insertion
The time (in seconds) from picking up the LMA to the first successful breath as confirmed by capnography.
Measured: Intraoperative (from LMA pick-up to successful placement).
Number of LMA insertion attempts
The total number of attempts required to successfully place the LMA. An attempt is defined as the introduction of the LMA into the patient's mouth.
Measured: Intraoperative (during the anesthesia induction phase).
Airway Responses
Incidence and severity of body movement, cough, breath-holding, and laryngospasm.
Measured: During and up to 1 minute post-insertion
Changes in Heart Rate (HR)
Evaluation of heart rate (beats per minute) to assess hemodynamic stability at four time points: T0 (baseline), T1 (post-induction), T2 (immediate post-insertion), and T3 (1 min post-insertion).
Measured: From baseline (pre-induction) up to 1 minute after LMA insertion.
Changes in Mean Arterial Pressure (MAP)
Evaluation of mean arterial pressure (mmHg) to assess hemodynamic stability at four time points: T0 (baseline), T1 (post-induction), T2 (immediate post-insertion), and T3 (1 min post-insertion).
Measured: From baseline (pre-induction) up to 1 minute after LMA insertion.
Awakening time
The interval from the discontinuation of anesthetic agents to the moment the patient follows simple commands or opens eyes.
Measured: From end of surgery up to 1 hour.
Post-Anesthesia Care Unit (PACU) discharge time
The duration (in minutes) from arrival in the PACU until the patient meets discharge criteria.
Measured: Up to PACU discharge(assessed up to 4 hours after surgery completion).
Postoperative Adverse Events
Incidence of PONV (postoperative nausea and vomiting), sore throat, and hoarseness.
Measured: At 6 hours and 24 hours post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start20 May 2026
- Primary completion10 Jul 2026
- Study completion11 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric AnesthesiaStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui Zhang, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581665
- Sponsor's protocol ID
- IIT2026026
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Dose of Alfentanil Combined With Propofol for Laryngeal Mask Airway Insertion in Children: A Prospective, Up-and-Down Sequential Allocation Study
- ClinicalTrials.gov ID
- NCT07581665
- Acronym / sponsor ID
- IIT2026026
- Conditions
- Pediatric Anesthesia, Airway Management, General Anesthesia, LMA
- Keywords
- Alfentanil, Propofol, Pediatric Anesthesia, LMA, Dixon Method, Effective dose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- 10 Jul 2026 (actual)
- Study completion
- 11 Jul 2026 (actual)
- First posted
- 12 May 2026 (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.
This study uses a prospective, up-and-down sequential allocation method to determine the median effective dose (ED50) and 95% effective dose (ED95) of alfentanil combined with propofol for successful laryngeal mask airway (LMA) insertion in children aged 7-12 undergoing elective day surgery.
Detailed description
Laryngeal mask airway (LMA) insertion is a common practice in pediatric day surgery. While it is less invasive than endotracheal intubation, children exhibit high airway reactivity, requiring an optimal depth of anesthesia to suppress airway reflexes. Alfentanil is an opioid with a rapid onset and short duration of action, making it potentially ideal for LMA insertion. However, current dosage recommendations for alfentanil are often extrapolated from tracheal intubation studies, which may lead to overdosage, respiratory depression, or delayed recovery in children. This study aims to determine the precise effective dose (ED50 and ED95) of alfentanil when combined with a fixed dose of propofol for smooth LMA insertion in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alfentanil Sequential Dose Group | Experimental | Drug: Alfentanil |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 7 to 12 years
- Undergoing elective day surgery
- ASA physical status I-II
- Body Mass Index (BMI) between 14 and 24 kg/m²
- Accompanied by a fully capable guardian within 24 hours after discharge
Key exclusion criteria (6 listed)
- Allergy to opioids
- Unresolved upper respiratory tract infection within the past 1 week
- Abnormal heart, lung, liver, or kidney function, or metabolic diseases
- Airway anatomical abnormalities (e.g., micrognathia, laryngomalacia, macroglossia) or OSAHS (Obstructive Sleep Apnea-Hypopnea Syndrome)
- Use of analgesics, sedatives, or other psychotropic drugs within the past 2 weeks
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 |
|---|---|---|
| AlfentanilAll patients receive 2.5 mg/kg propofol injected over 30 seconds. Alfentanil is administered 1 minute prior to propofol. The dose is adjusted by steps of 2 µg/kg based on the previous patient's response (successful insertion = decrease dose; failed insertion = increase dose). | Drug | Alfentanil Sequential Dose Group |
Primary outcome
Success of LMA insertion
Time frame: Intraoperative (During LMA insertion procedure)
Assessed by the absence of body movement, coughing, breath-holding, severe hemodynamic changes, or insertion difficulty.
8 secondary outcomes
Time required for LMA insertion
Time frame: Intraoperative (from LMA pick-up to successful placement).
Number of LMA insertion attempts
Time frame: Intraoperative (during the anesthesia induction phase).
Airway Responses
Time frame: During and up to 1 minute post-insertion
Changes in Heart Rate (HR)
Time frame: From baseline (pre-induction) up to 1 minute after LMA insertion.
Changes in Mean Arterial Pressure (MAP)
Time frame: From baseline (pre-induction) up to 1 minute after LMA insertion.
Awakening time
Time frame: From end of surgery up to 1 hour.
Post-Anesthesia Care Unit (PACU) discharge time
Time frame: Up to PACU discharge(assessed up to 4 hours after surgery completion).
Postoperative Adverse Events
Time frame: At 6 hours and 24 hours post-operation
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 7 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Alfentanil in people with Pediatric Anesthesia and Airway Management, run by Zhongshan Ophthalmic Center, Sun Yat-sen 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 5 inclusion and 6 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 7 Oct 2026. 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?
Success of LMA insertion (time frame: Intraoperative (During LMA insertion 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 7 Oct 2026.