The Effect of Anaesthesia Depth on Oculo-cardiac Reflex

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02379546

Enrollment

Registered

2015-03-05

Start date

2013-08-31

Completion date

2015-05-31

Last updated

2015-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, General, Strabismus

Keywords

reflex, oculocardiac, monitoring, intraoperative

Brief summary

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

Detailed description

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.

Interventions

DRUGDesflurane

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

DEVICEBispectral index monitoring

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

3 Years to 16 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026