Clinical Trial: Isoflurane Versus Propofol for Removal of LMA in Children

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Isoflurane Versus Small Dose Propofol With Isoflurane for Removal of Laryngeal Mask Airway in Anesthetized Children

Brief Summary:

The study will be done in pediatric population by comparing two techniques of Laryngeal Mask Airway (LMA) removal under the deep anesthesia.

The both study techniques will be compared on the basis of smooth Laryngeal Mask Airway removal, emergence time and the duration of recovery room stay.


Detailed Summary:

  • Study will be start after confirming the approval of institutional ethical review committee and after fulfilling the study inclusion criteria. The detailed study protocol will be explain to the parent/guardian and written & informed consent will be taking on his/her will.

  • Inclusion Criteria

    • Age between 2 to 10 years,
    • American Society of Anaesthesiologists (ASA) physical status I & II,
    • Patient is not contraindicated to Laryngeal Mask Airway insertion,
    • Elective below umbilical general surgical procedures
    • patient is planned for general anesthesia with spontaneous breathing.
  • Fifty patients will participate in both study groups.
  • All patients will be premedicated with oral midazolam 0.4mg/kg, 45 to 60 minutes prior to induction.
  • After arrival of patients in operating room, routine anesthesia monitoring will be applied and baseline blood pressure, heart rate, respiratory rate and oxygen saturation will be recorded.
  • Patient will be induced with anesthetic induction inhalational agent (sleeping drug) sevoflurane 8% with oxygen by pediatric anesthesia circle system. The sevoflurane concentration will be adjusted to 3.5% to 4% once the adequate depth of anesthesia achieved, as evident by jaw relaxation, need and tolerance of an oral airway.
  • The LMA will be placed after the insertion of intravenous line.
  • The LMA size will be determined as per manufacturer's recommendation; whic
    Sponsor: Aga Khan University

    Current Primary Outcome: Assessment of Smooth LMA removal by looking at adverse airway events [ Time Frame: Assessment will be starting from LMA removal to 15 minutes ]

    Smooth LMA removal will be assessed by adverse airway events like; coughing, bucking, hypersalivation, O2 desaturation (Sp02<90%), airway obstruction (noisy or stridor breathing) requiring jaw support, laryngospasm, bronchospasm, retching and vomiting, time duration from LMA removal up to 15 minutes.


    Original Primary Outcome: Same as current

    Current Secondary Outcome: Emergence time will be monitored by patients awakening after LMA removal [ Time Frame: Time duration will be assessed from LMA removal, maximum for 15 minutes. ]

    The emergence time like time to awakening after LMA removal.


    Original Secondary Outcome: Same as current

    Information By: Aga Khan University

    Dates:
    Date Received: June 19, 2012
    Date Started: April 2012
    Date Completion: December 2013
    Last Updated: October 8, 2013
    Last Verified: October 2013