Propofol Versus Sevoflurane Anesthesia in Pediatric Strabismus Surgery: Feasibility of BIS Monitoring
- Conditions
- Strabismus
- Interventions
- Registration Number
- NCT04485117
- Lead Sponsor
- Sameh Fathy
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- American Society of Anesthesiology (ASA) I and II patients.
- Scheduled for elective Strabismus surgery.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sevoflurane Group Laryngeal Mask Airway Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane anesthesia under BIS monitoring. Sevoflurane Group Bispectral Index Monitor Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane anesthesia under BIS monitoring. Propofol Group Laryngeal Mask Airway Laryngeal mask airway is inserted and anesthesia is maintained with propofol infusion under BIS monitoring. Propofol Group Bispectral Index Monitor Laryngeal mask airway is inserted and anesthesia is maintained with propofol infusion under BIS monitoring. Sevoflurane Group Sevoflurane Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane anesthesia under BIS monitoring. Propofol Group Propofol Laryngeal mask airway is inserted and anesthesia is maintained with propofol infusion under BIS monitoring.
- Primary Outcome Measures
Name Time Method Incidence of oculocardiac reflex 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 Outcome Measures
Name Time Method First analgesic request Up to 24 hours after surgery The time of the first analgesic request for paracetamol is recorded.
Changes in bispectral index Up to the end of the surgery Bispectral index values (0-100) are recorded every five minutes until the end of the surgery
Changes in heart rate Up to the end of the surgery Heart rate (beat/min) is recorded at five-minute intervals until the end of the surgery
Changes in postoperative emergence agitation scale Up to 30 minutes after surgery Agitation is assessed using the 5- step Cravero scale (1-5) every five minutes from awakening and for 30 minutes.(1:Obtunded with no response to stimulation, 2:Asleep but responsive to movement or stimulation, 3:Awake and responsive, 4:Crying, 5:Thrashing behaviour that requires restraint)
Changes in mean arterial blood pressure Up to the end of the surgery Mean blood pressure (mmHg) is recorded at five-minute intervals until the end of the surgery
Changes in postoperative pain score Up to 24 hours after surgery Pain score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) is assessed every two hours for 24 hours after surgery.
Incidence of postoperative nausea and vomiting Up to 24 hours after surgery Incidence of postoperative nausea and vomiting is assessed during the first 24 hours post-operatively.
Total analgesic requirements of paracetamol Up to 24 hours after surgery The amount of paracetamol consumption given as a rescue analgesia to patients is measured all over the 24 hours.
Trial Locations
- Locations (1)
Department of Anesthesia, Mansoura University Hospitals
🇪🇬Mansoura, Dakahlia, Egypt
Department of Anesthesia, Mansoura University Hospitals🇪🇬Mansoura, Dakahlia, Egypt