search
Back to results

The Effect of Anaesthesia Depth on Oculo-cardiac Reflex

Primary Purpose

Strabismus, Anesthesia, General

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Desflurane
Bispectral index monitoring
Sponsored by
Tokat Gaziosmanpasa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Strabismus focused on measuring reflex, oculocardiac, monitoring, intraoperative

Eligibility Criteria

3 Years - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Tuğba Karaman

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BIS<50

BIS≥50

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 17, 2015
Last Updated
May 27, 2015
Sponsor
Tokat Gaziosmanpasa University
search

1. Study Identification

Unique Protocol Identification Number
NCT02379546
Brief Title
The Effect of Anaesthesia Depth on Oculo-cardiac Reflex
Official Title
The Effect of Anaesthesia Depth on Oculo-cardiac Reflex in Strabismus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strabismus, Anesthesia, General
Keywords
reflex, oculocardiac, monitoring, intraoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIS<50
Arm Type
Experimental
Arm 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.
Arm Title
BIS≥50
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Desflurane
Intervention Description
Desflurane will be used to maintain the anesthesia and the dose of desflurane will be adjusted according to the Bispectral İndex Monitoring
Intervention Type
Device
Intervention Name(s)
Bispectral index monitoring
Other Intervention Name(s)
BIS
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuğba Karaman
Organizational Affiliation
GOU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tuğba Karaman
City
Tokat
State/Province
Merkez
ZIP/Postal Code
60100
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

The Effect of Anaesthesia Depth on Oculo-cardiac Reflex

We'll reach out to this number within 24 hrs