The Effect of Anaesthesia Depth on Oculo-cardiac Reflex

Phase 4

Completed

• Conditions: Strabismus; Anesthesia, General
• Interventions: Drug: Desflurane; Device: Bispectral index monitoring

• Registration Number: NCT02379546
• Lead Sponsor: Tokat Gaziosmanpasa University

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2015-02-17
• Study First Submitted QC: 2015-02-26
• Study First Posted: 2015-03-05
• Status Verified: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIS<50	Bispectral index monitoring	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.
BIS≥50	Bispectral index monitoring	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.
BIS<50	Desflurane	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.
BIS≥50	Desflurane	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Tuğba Karaman; 🇹🇷 Tokat, Merkez, Turkey