NCT07673003

Brief Summary

The goal of this clinical trial is to compare two commonly used anesthetic medicines, sevoflurane and propofol, for inserting a laryngeal mask airway (LMA) in children undergoing minor elective surgery. A laryngeal mask airway is a device placed in the throat to help children breathe safely during anesthesia. The main questions this study aims to answer are:

  • Does sevoflurane produce a faster onset of anesthesia than propofol?
  • Is there a difference between sevoflurane and propofol in the time required to achieve jaw relaxation for LMA insertion?
  • Is there a difference between the two medicines in the time required for successful LMA insertion? The researchers hypothesize that children receiving sevoflurane will have a shorter induction time than those receiving propofol. A total of 170 children aged 4 to 12 years who are undergoing minor surgical procedures below the umbilicus will participate in the study. Participants will be randomly assigned to receive either intravenous propofol or inhaled sevoflurane for induction of anesthesia. During the procedure, the anesthesia team will measure the time taken to lose consciousness, the time required to achieve adequate jaw relaxation, and the time needed for successful insertion of the laryngeal mask airway. These measurements will help determine which anesthetic agent provides better conditions for LMA insertion in children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 29, 2026

Completed
Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 17, 2026

Last Update Submit

June 24, 2026

Conditions

Keywords

SevofluranePropofolLaryngeal Mask AirwayPediatric AnesthesiaJaw RelaxationElective Surgery

Outcome Measures

Primary Outcomes (1)

  • Time to Induction of Anesthesia

    Time (in seconds) measured from administration of the induction agent (propofol or sevoflurane) to loss of consciousness, defined as loss of verbal response and loss of eyelash reflex in pediatric patients undergoing elective surgery for laryngeal mask airway insertion.

    From administration of the induction agent until loss of consciousness, assessed for up to 5 minutes after induction.

Other Outcomes (2)

  • Time to Jaw Relaxation

    From administration of the induction agent until achievement of adequate jaw relaxation (mouth opening >4 cm), assessed for up to 5 minutes after induction.

  • Time to Laryngeal Mask Airway (LMA) Insertion

    From administration of the induction agent until successful laryngeal mask airway insertion, assessed for up to 5 minutes after induction.

Study Arms (2)

Propofol Group

ACTIVE COMPARATOR

Children in this group will receive intravenous propofol as the induction agent for general anesthesia prior to laryngeal mask airway (LMA) insertion.

Drug: propofol

Sevoflurane Group

EXPERIMENTAL

hildren in this group will receive inhalational sevoflurane for induction of general anesthesia prior to laryngeal mask airway (LMA) insertion.

Drug: Sevoflurane

Interventions

Intravenous propofol 3 mg/kg bolus will be administered for induction of general anesthesia before LMA insertion in pediatric patients.

Propofol Group

Sevoflurane 7% will be delivered via inhalation in a nitrous oxide/oxygen mixture (2:1) for induction of general anesthesia prior to LMA insertion in pediatric patients.

Sevoflurane Group

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA physical status 1 and 2
  • Undergoing elective minor surgical procedures below umbilicus
  • Procedure lasting less than 60 min

You may not qualify if:

  • Recent respiratory tract infection
  • Bronchial asthma
  • Family history of malignant hyperthermia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital and Institute of Child Health Multan

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Interventions

PropofolSevoflurane

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Syed S Abbas, FCPS

    Children's Hospital and Institute of Child Health, Multan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 29, 2026

Study Start

June 1, 2025

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

June 29, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations