Children's Hospital and Institute of Child Health Multan
Multan, Punjab Province, 60000, Pakistan
NCT Number: NCT07673003
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.
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Notify Me4 year–12 year
All sexes
Interventional
Phase 4
Multan, Punjab Province, 60000, Pakistan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous propofol 3 mg/kg bolus will be administered for induction of general anesthesia before LMA insertion in pediatric patients.
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.
Time frame: From administration of the induction agent until loss of consciousness, assessed for up to 5 minutes after induction.
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.
Time frame: 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 (in seconds) measured from administration of induction agent to adequate jaw relaxation, defined as sufficient mouth opening (>4 cm) allowing insertion of laryngeal mask airway.
Time frame: From administration of the induction agent until successful laryngeal mask airway insertion, assessed for up to 5 minutes after induction.
Time (in seconds) measured from administration of induction agent to successful insertion of laryngeal mask airway using standard technique.
Children's Hospital and Institute of Child Health, Multan
Other Gov
Comparison of Sevoflurane and Propofol for Laryngeal Mask Airway Insertion in Children
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