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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevoflurane Group | Active Comparator | Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane anesthesia under BIS monitoring. |
|
| Propofol Group | Active Comparator | Laryngeal mask airway is inserted and anesthesia is maintained with propofol infusion under BIS monitoring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bispectral Index Monitor | Device | Bispectral Index (BIS) sensor electrodes are applied over the patient's forehead after cleaning the forehead thoroughly with an alcohol swab. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sameh M El-Sherbiny, MD | Mansoura Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia, Mansoura University Hospitals | Al Mansurah | Dakahlia Governorate | 35511 | Egypt |
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| ID | Term |
|---|---|
| D013285 | Strabismus |
| ID | Term |
|---|---|
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D056805 | Consciousness Monitors |
| D017214 | Laryngeal Masks |
| D000077149 | Sevoflurane |
| D015742 | Propofol |
| D000771 | Anesthesia, Intravenous |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D007442 | Intubation, Intratracheal |
| D058109 | Airway Management |
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|
| Laryngeal Mask Airway | Device | 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. |
|
|
| Sevoflurane | Drug | 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. |
|
|
| Propofol | Drug | 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 . |
|
|
| 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 |
| D013812 |
| Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
| D008397 | Masks |
| D011482 | Protective Devices |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |