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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alfentanil Sequential Dose Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alfentanil | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Success of LMA insertion | Assessed by the absence of body movement, coughing, breath-holding, severe hemodynamic changes, or insertion difficulty. | Intraoperative (During LMA insertion procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Time required for LMA insertion | The time (in seconds) from picking up the LMA to the first successful breath as confirmed by capnography. | Intraoperative (from LMA pick-up to successful placement). |
| Number of LMA insertion attempts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Zhang, M.D. | Contact | +86 15802025520 | zhangr52@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D015760 | Alfentanil |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
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.
| Intraoperative (during the anesthesia induction phase). |
| Airway Responses | Incidence and severity of body movement, cough, breath-holding, and laryngospasm. | 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). | 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). | 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. | 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. | 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. | At 6 hours and 24 hours post-operation |