The Effect of Anaesthesia Depth on Oculo-cardiac Reflex

May 27, 2015 updated by: Tuğba Karaman, Tokat Gaziosmanpasa University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Merkez
      • Tokat, Merkez, Turkey, 60100
        • Tuğba Karaman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BIS<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 below 50.
Drug: Desflurane
Desflurane will be used to maintain the anesthesia and the dose of desflurane will be adjusted according to the Bispectral İndex Monitoring
Device: Bispectral 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
Other Names:
  • BIS
Active Comparator: BIS≥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.
Drug: Desflurane
Desflurane will be used to maintain the anesthesia and the dose of desflurane will be adjusted according to the Bispectral İndex Monitoring
Device: Bispectral 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
Other Names:
  • BIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
during the traction of the extra-ocular muscle in the strabismus surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
during the traction of the extra-ocular muscle in the strabismus surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokat Gaziosmanpasa University

Investigators

  • Principal Investigator: Tuğba Karaman, GOU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

February 17, 2015

First Submitted That Met QC Criteria

February 26, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GaziosmanpashaU-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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