Propofol Versus Sevoflurane Anesthesia in Pediatric Strabismus Surgery: Feasibility of BIS Monitoring

Sameh Fathy

Status: Completed

Conditions: Strabismus

Treatments: Drug: Propofol; Drug: Sevoflurane; Device: Laryngeal Mask Airway; Device: Bispectral Index Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT04485117

BIS Monitoring in Strabismus

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 3 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Sevoflurane Group

Active Comparator group

Description:

Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane anesthesia under BIS monitoring.

Treatment:

Device: Bispectral Index Monitor

Device: Laryngeal Mask Airway

Drug: Sevoflurane

Propofol Group

Active Comparator group

Description:

Laryngeal mask airway is inserted and anesthesia is maintained with propofol infusion under BIS monitoring.

Treatment:

Device: Bispectral Index Monitor

Device: Laryngeal Mask Airway

Drug: Propofol