Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07581665

Effective Dose of Alfentanil Combined With Propofol for Laryngeal Mask Airway Insertion in Children

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pediatric Anesthesia Airway Management General Anesthesia LMA

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology, Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location contact

Tairan Lin, M.D.

CONTACT

[email protected]

+86 15622130745

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time required for LMA insertion

    Time frame: Intraoperative (from LMA pick-up to successful placement).

    The time (in seconds) from picking up the LMA to the first successful breath as confirmed by capnography.

  2. Number of LMA insertion attempts

    Time frame: Intraoperative (during the anesthesia induction phase).

    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.

  3. Airway Responses

    Time frame: During and up to 1 minute post-insertion

    Incidence and severity of body movement, cough, breath-holding, and laryngospasm.

  4. Changes in Heart Rate (HR)

    Time frame: From baseline (pre-induction) up to 1 minute after LMA insertion.

    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).

  5. Changes in Mean Arterial Pressure (MAP)

    Time frame: From baseline (pre-induction) up to 1 minute after LMA insertion.

    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).

  6. Awakening time

    Time frame: From end of surgery up to 1 hour.

    The interval from the discontinuation of anesthetic agents to the moment the patient follows simple commands or opens eyes.

  7. Post-Anesthesia Care Unit (PACU) discharge time

    Time frame: Up to PACU discharge(assessed up to 4 hours after surgery completion).

    The duration (in minutes) from arrival in the PACU until the patient meets discharge criteria.

  8. Postoperative Adverse Events

    Time frame: At 6 hours and 24 hours post-operation

    Incidence of PONV (postoperative nausea and vomiting), sore throat, and hoarseness.

Study contacts

Contact information is provided by the study sponsor or research team.

Rui Zhang, M.D.

CONTACT

[email protected]

+86 15802025520

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

Effective Dose of Alfentanil Combined With Propofol for Laryngeal Mask Airway Insertion in Children: A Prospective, Up-and-Down Sequential Allocation Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.