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

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Abstract

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.

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.

Dates

Last Verified:	06/30/2020
First Submitted:	07/20/2020
Estimated Enrollment Submitted:	07/20/2020
First Posted:	07/23/2020
Last Update Submitted:	07/20/2020
Last Update Posted:	07/23/2020
Actual Study Start Date:	12/31/2019
Estimated Primary Completion Date:	06/30/2020
Estimated Study Completion Date:	07/20/2020

Condition or disease

Strabismus

Intervention/treatment

Device: Bispectral Index Monitor

Device: Laryngeal Mask Airway

Drug: Sevoflurane Group

Drug: Propofol Group

Phase

Arm Groups

Arm	Intervention/treatment
Active Comparator: Sevoflurane Group Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane anesthesia under BIS monitoring.	Drug: Sevoflurane Group 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.
Active Comparator: Propofol Group Laryngeal mask airway is inserted and anesthesia is maintained with propofol infusion under BIS monitoring.	Drug: Propofol Group 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 .

Eligibility Criteria

Ages Eligible for Study	3 Years To 3 Years
Sexes Eligible for Study	All
Accepts Healthy Volunteers	Yes
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.

Outcome

Primary Outcome Measures

1. 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

1. 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

2. 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

3. Changes in mean arterial blood pressure [Up to the end of the surgery]

Blood pressure (mmHg) is recorded at five-minute intervals until the end of the surgery

4. Improvement 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)

5. Improvement 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.

6. First analgesic request [Up to 24 hours after surgery]

The time of the first analgesic request for paracetamol is recorded.

7. 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.

8. 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.

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

Keywords

nausea

vomiting

strabismus

emergence delirium