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The Effect of Anaesthesia Depth on Oculo-cardiac Reflex

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ClinicalTrials.gov Identifier: NCT02379546
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
Tuğba Karaman, 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.

Condition or disease Intervention/treatment Phase
Strabismus Anesthesia, General Drug: Desflurane Device: Bispectral index monitoring Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of Anaesthesia Depth on Oculo-cardiac Reflex in Strabismus Surgery
Study Start Date : August 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Desflurane

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 Name: 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 Name: BIS




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


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Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02379546


Locations
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Turkey
Tuğba Karaman
Tokat, Merkez, Turkey, 60100
Sponsors and Collaborators
Tokat Gaziosmanpasa University
Investigators
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Principal Investigator: Tuğba Karaman GOU
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Responsible Party: Tuğba Karaman, assistant professor, Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier: NCT02379546    
Other Study ID Numbers: GaziosmanpashaU-2
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Keywords provided by Tuğba Karaman, Tokat Gaziosmanpasa University:
reflex, oculocardiac
monitoring, intraoperative
Additional relevant MeSH terms:
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Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Desflurane
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs