The Effect of Anaesthesia Depth on Oculo-cardiac Reflex

Tokat Gaziosmanpasa University

Status and phase: Completed; Phase 4

Conditions: Strabismus; Anesthesia, General

Treatments: Device: Bispectral index monitoring; Drug: Desflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT02379546

GaziosmanpashaU-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 3 to 16 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

BIS<50

Experimental group

Description:

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.

Treatment:

Device: Bispectral index monitoring

Drug: Desflurane

BIS≥50

Active Comparator group

Description:

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.

Treatment:

Device: Bispectral index monitoring

Drug: Desflurane