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Completed

NCT Number: NCT02379546

The Effect of Anaesthesia Depth on Oculo-cardiac Reflex

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

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Key information

Conditions

Strabismus Anesthesia, General Cranial Nerve Diseases Eye Diseases Nervous System Diseases Ocular Motility Disorders

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tuğba Karaman

Tokat Province, Merkez, 60100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desflurane

Drug

Desflurane will be used to maintain the anesthesia and the dose of desflurane will be adjusted according to the Bispectral İndex Monitoring

Bispectral Index Monitoring

Device

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

Other names: BIS

Primary outcomes

  1. The effect of the anaesthesia depth on the incidence of oculocardiac reflex

    Time frame: during the traction of the extra-ocular muscle in the strabismus surgery

Secondary outcomes

  1. The incidence of the oculocardiac reflex depending the type of operated extra-ocular muscle during the strabismus surgery

    Time frame: during the traction of the extra-ocular muscle in the strabismus surgery

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 5, 2015
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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