Propofol Versus Sevoflurane Anesthesia in Pediatric Strabismus Surgery: Feasibility of BIS Monitoring
Overview
- Phase
- Not Applicable
- Intervention
- Bispectral Index Monitor
- Conditions
- Strabismus
- Sponsor
- Sameh Fathy
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Incidence of oculocardiac reflex
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Sameh Fathy
Lecturer of anesthesia, ICU & pain management; Faculty of Medicine
Mansoura University
Eligibility Criteria
Inclusion Criteria
- •American Society of Anesthesiology (ASA) I and II patients.
- •Scheduled for elective Strabismus surgery.
Exclusion Criteria
- •Parental refusal of consent.
- •Hyperactive airway disease or respiratory diseases.
- •Children with developmental delays, mental or neurological disorders.
- •Bleeding or coagulation diathesis.
- •History of known sensitivity to the used anesthetics.
- •Children with previous surgery in the eye.
Arms & Interventions
Sevoflurane Group
Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane anesthesia under BIS monitoring.
Intervention: Bispectral Index Monitor
Sevoflurane Group
Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane anesthesia under BIS monitoring.
Intervention: Laryngeal Mask Airway
Sevoflurane Group
Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane anesthesia under BIS monitoring.
Intervention: Sevoflurane
Propofol Group
Laryngeal mask airway is inserted and anesthesia is maintained with propofol infusion under BIS monitoring.
Intervention: Bispectral Index Monitor
Propofol Group
Laryngeal mask airway is inserted and anesthesia is maintained with propofol infusion under BIS monitoring.
Intervention: Laryngeal Mask Airway
Propofol Group
Laryngeal mask airway is inserted and anesthesia is maintained with propofol infusion under BIS monitoring.
Intervention: Propofol
Outcomes
Primary Outcomes
Incidence of oculocardiac reflex
Time Frame: Up to the end of the surgery
Any dysrhythmia or rapid reduction in HR by more than 25% from the baseline is taken as oculocardiac reflex.
Secondary Outcomes
- First analgesic request(Up to 24 hours after surgery)
- Changes in bispectral index(Up to the end of the surgery)
- Changes in heart rate(Up to the end of the surgery)
- Changes in postoperative emergence agitation scale(Up to 30 minutes after surgery)
- Changes in mean arterial blood pressure(Up to the end of the surgery)
- Changes in postoperative pain score(Up to 24 hours after surgery)
- Incidence of postoperative nausea and vomiting(Up to 24 hours after surgery)
- Total analgesic requirements of paracetamol(Up to 24 hours after surgery)