Propofol Versus Sevoflurane Anesthesia in Pediatric Strabismus Surgery: Feasibility of BIS Monitoring
Condition: Strabismus
MeSH terms: Strabismus
Study type: Interventional

Summary: 
      This study is conducted to evaluate importance of bispectral index (BIS) monitoring in
      patients undergoing strabismus surgery when using propofol in comparison to sevoflurane
      anesthesia regarding their effects on oculocardiac reflex, intraoperative hemodynamic
      stability, emergence agitation, postoperative pain, nausea and vomiting.
    

Detailed description: 
      Strabismus surgery can cause unfavorable side effects during intraoperative and postoperative
      periods including increased risk of the oculocardiac reflex, hemodynamic instability,
      emergence agitation, postoperative pain, nausea and vomiting. Sevoflurane is an inhalation
      anesthetic widely used in pediatric anesthesia with minimal airway irritation. Propofol is an
      intravenous sedative-hypnotic agent with amnestic properties that causes loss of
      consciousness. Bispectral index monitor provide some more evidence that deeper anesthesia can
      provide some protection against the oculocardiac reflex. Therefore, this study is conducted
      to evaluate the role of BIS monitoring in comparing the use of propofol and sevoflurane
      anesthesia in pediatric strabismus surgery.

      This prospective, randomized, comparative clinical study will include 100 children who are
      scheduled for elective strabismus surgery under general anesthesia in Mansoura ophthalmology
      center. Informed written consent is obtained from parents of all subjects in the study after
      ensuring confidentiality. The study protocol is explained to parents of all patients in the
      study who are kept fasting prior to surgery. Patients are randomly assigned to two equal
      groups according to computer-generated table of random numbers using the permuted block
      randomization method. The collected data are coded, processed, and analyzed using SPSS
      program. All data are considered statistically significant if P value is ≤ 0.05.
    

Intervention name(s): Bispectral Index Monitor; Laryngeal Mask Airway; Sevoflurane; Propofol
Intervention type(s): Device; Device; Drug; Drug
Intervention description(s): Bispectral Index (BIS) sensor electrodes are applied over the patient's forehead after cleaning the forehead thoroughly with an alcohol swab.; Capnography connected to laryngeal mask airway is introduced after adequate jaw relaxation and oral airway tolerance; its size is chosen according to the body weight of the child.; Anesthesia is induced inhalationally by face mask with 8% sevoflurane in 100% oxygen, then decreased to 2-3% in 40% oxygen thoroughout the operation for maintenance of anesthesia.; Anesthesia is induced by propofol (2mg/kg), then maintained using an infusion of fixed concentration (10-15 mg/kg/h) as titrated by the anesthesiologist .
Other intervention name(s): BIS Monitoring; Supraglottic Airway Device; Inhalational Anesthesia; Intravenous Anesthesia
Intervention MeSH terms: Anesthetics; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bispectral Index Monitoring