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

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.

Study Overview

• Status: Completed
• Conditions: Strabismus
• Intervention / Treatment: Device: Bispectral Index Monitor; Device: Laryngeal Mask Airway; Drug: Sevoflurane; Drug: Propofol

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35511
      • Department of Anesthesia, Mansoura University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sevoflurane Group; Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane anesthesia under BIS monitoring.	Device: Bispectral Index Monitor; Bispectral Index (BIS) sensor electrodes are applied over the patient's forehead after cleaning the forehead thoroughly with an alcohol swab.; Other Names: BIS Monitoring; Device: Laryngeal Mask Airway; 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.; Other Names: Supraglottic Airway Device; Drug: Sevoflurane; 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.; Other Names: Inhalational Anesthesia
Active Comparator: Propofol Group; Laryngeal mask airway is inserted and anesthesia is maintained with propofol infusion under BIS monitoring.	Device: Bispectral Index Monitor; Bispectral Index (BIS) sensor electrodes are applied over the patient's forehead after cleaning the forehead thoroughly with an alcohol swab.; Other Names: BIS Monitoring; Device: Laryngeal Mask Airway; 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.; Other Names: Supraglottic Airway Device; Drug: Propofol; 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 Names: Intravenous Anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of oculocardiac reflex	Any dysrhythmia or rapid reduction in HR by more than 25% from the baseline is taken as oculocardiac reflex.	Up to the end of the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in bispectral index	Bispectral index values (0-100) are recorded every five minutes until the end of the surgery	Up to the end of the surgery
Changes in heart rate	Heart rate (beat/min) is recorded at five-minute intervals until the end of the surgery	Up to the end of the surgery
Changes in mean arterial blood pressure	Mean blood pressure (mmHg) is recorded at five-minute intervals until the end of the surgery	Up to the end of the surgery
Changes in postoperative emergence agitation scale	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)	Up to 30 minutes after surgery
Changes in postoperative pain score	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.	Up to 24 hours after surgery
First analgesic request	The time of the first analgesic request for paracetamol is recorded.	Up to 24 hours after surgery
Total analgesic requirements of paracetamol	The amount of paracetamol consumption given as a rescue analgesia to patients is measured all over the 24 hours.	Up to 24 hours after surgery
Incidence of postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting is assessed during the first 24 hours post-operatively.	Up to 24 hours after surgery

Collaborators and Investigators

• Sponsor: Sameh Fathy

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 21, 2020

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Bispectral Index Monitoring
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Anesthetics; Propofol; Sevoflurane
• Other Study ID Numbers: BIS Monitoring in Strabismus

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No