Clinical trial NCT04485117: Propofol Versus Sevoflurane Anesthesia in Pediatric Strabismus Surgery: Feasibility of BIS Monitoring
Official title: Propofol Versus Sevoflurane Anesthesia in Pediatric Strabismus Surgery: Feasibility of BIS Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Strabismus
Keywords: Bispectral Index Monitoring
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of oculocardiac reflex
timeFrame: Up to the end of the surgery
Secondary outcomes:
measure: Changes in bispectral index
timeFrame: Up to the end of the surgery
measure: Changes in heart rate
timeFrame: Up to the end of the surgery
measure: Changes in mean arterial blood pressure
timeFrame: Up to the end of the surgery
measure: Changes in postoperative emergence agitation scale
timeFrame: Up to 30 minutes after surgery
measure: Changes in postoperative pain score
timeFrame: Up to 24 hours after surgery
measure: First analgesic request
timeFrame: Up to 24 hours after surgery
measure: Total analgesic requirements of paracetamol
timeFrame: Up to 24 hours after surgery
measure: Incidence of postoperative nausea and vomiting
timeFrame: Up to 24 hours after surgery
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Department of Anesthesia, Mansoura University Hospitals
state: Dakahlia
Study officials:
affiliation: Mansoura Faculty of Medicine
name: Sameh M El-Sherbiny, MD
role: PRINCIPAL_INVESTIGATOR
References: