The Effect of Anaesthesia Depth on Oculo-cardiac Reflex

Anesthesia, General Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379546
• Other study ID #: GaziosmanpashaU-2
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2015
• Last updated: May 27, 2015
• Start date: August 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Tokat Gaziosmanpasa University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Drug and Medical Device Institution
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 16 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anesthesia, General
• Strabismus

Intervention

Drug:
• Desflurane
Desflurane will be used to maintain the anesthesia and the dose of desflurane will be adjusted according to the Bispectral Index Monitoring

Device:
• Bispectral index monitoring
Bispectral index monitoring (BIS XP, A-2000, VERSION 3.31, Aspect Medical Systems, Newton, Mass, USA)will be used to determine the depth of anesthesia

Locations

Country	Name	City	State
Turkey	Tugba Karaman	Tokat	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of the anaesthesia depth on the incidence of oculocardiac reflex		during the traction of the extra-ocular muscle in the strabismus surgery	Yes
Secondary	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	Yes