The Effect of Anaesthesia Depth on Oculo-cardiac Reflex

Study Overview
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Brief Summary
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This study was designed to determine the effect of the depth of anesthesia on the oculocardiac reflex (OCR) during pediatric strabismus surgery.

Detailed Description
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The oculo-cardiac reflex (OCR) is a trigeminovagal reflex which is started by the stimulus on the extra-ocular muscle and may lead to serious bradycardia or arrhythmia in the patients during strabismus surgery. It is presumed that the depth of anesthesia is one of the influencing factor on the OCR. But the clinical trials which are evaluating the relationship between the anesthesia depth and OCR are scarce. The main objective of this study is to determine the impact of the depth of anaesthesia that is adjusted with the bispectral index (BIS) monitor on the incidence of OCR in pediatric patients undergoing strabismus surgery.

Official Title
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The Effect of Anaesthesia Depth on Oculo-cardiac Reflex in Strabismus Surgery

Conditions
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Strabismus, Anesthesia, General

Intervention / Treatment
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* Drug: Desflurane
* Device: Bispectral index monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: physical status ASA (American Society of Anesthesiologists) I scheduled for elective strabismus surgery under general anesthesia aged between 3-16 years Exclusion Criteria: have a neurological or cardiovascular disease receiving antiepileptic or another medications known to affect EEG or ECG

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIS<50<br>Anaesthesia will be maintained with desflurane in a 50% O2-Air mixture by titrating the concentration according to the Bispectral index monitoring to keep the Bispectral index values below 50. | Drug: Desflurane<br>* Desflurane will be used to maintain the anesthesia and the dose of desflurane will be adjusted according to the Bispectral İndex Monitoring<br>Device: Bispectral index monitoring<br>* Bispectral index monitoring (BIS XP, A-2000, VERSİON 3.31, Aspect Medical Systems, Newton, Mass, USA)will be used to determine the depth of anesthesia<br>* Other names: BIS;|
| Active Comparator: BIS≥50<br>Anaesthesia will be maintained with desflurane in a 50% O2-Air mixture by titrating the concentration according to the Bispectral index monitoring to keep the Bispectral index values above 50. | Drug: Desflurane<br>* Desflurane will be used to maintain the anesthesia and the dose of desflurane will be adjusted according to the Bispectral İndex Monitoring<br>Device: Bispectral index monitoring<br>* Bispectral index monitoring (BIS XP, A-2000, VERSİON 3.31, Aspect Medical Systems, Newton, Mass, USA)will be used to determine the depth of anesthesia<br>* Other names: BIS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of the anaesthesia depth on the incidence of oculocardiac reflex |  | during the traction of the extra-ocular muscle in the strabismus surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of the oculocardiac reflex depending the type of operated extra-ocular muscle during the strabismus surgery |  | during the traction of the extra-ocular muscle in the strabismus surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reflex, oculocardiac, monitoring, intraoperative