The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000551291
Ethics application status
Approved
Date submitted
11/01/2018
Date registered
12/04/2018
Date last updated
4/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does mouth gag application during Tonsillectomy or Adentonsillectomy alter optic nerve sheath diameter?
Scientific title
Effect of Mouth Gag on Optic Nerve Sheath Diameter in Patients Undergoing Tonsillectomy or Adenotonsillectomy
Secondary ID [1] 293541 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
tonsillectomy 305748 0
adenotonsillectomy 305749 0
Condition category
Condition code
Oral and Gastrointestinal 304962 304962 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 304965 304965 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this study we are using a rapid ultrasound procedure to the eye to look at the optic nerve sheath (ONS) diameter. The ultrasound will be applied by anesthesist who is certified to use ultrasound. The ultrasound scan involves gentle placement of an ultrasound probe on the closed eyelid of generally anesthetized patient undergoing tonsillectomy or adenotonsillectomy. The ultrasound will be applied as with the patient supine horizontally, a two-dimensional axial cross-sectional view of the ONSD will be obtained by positioning a 6-13 MHz transducer transversely on a single closed eyelid. On the ultrasound monitor, the ONSD will be measured 3 mm posterior to the orbital globe. Each measurement will be performed on the same orbit ONS diameter measurements will be compared at four time frames (after anesthesia induction, after tracheal intubation, after mouth gag application, 30 minutes after application)
Intervention code [1] 299787 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304146 0
Change in optic nerve sheath diameter as assessed by rapid ultrasound scan after general anaesthesia induction, after tracheal intubation, mouth gag insertion and 30 minutes after mouth gag insertion
Timepoint [1] 304146 0
After general anesthesia induction, after endotracheal intubation, after mouth gag insertion (primary timepoint), 20 minutes after mouth gag insertion
Secondary outcome [1] 341099 0
Change in mean arterial pressure by using blood pressure monitor on the anesthesia workstation
Timepoint [1] 341099 0
After general anaesthesia induction, after endotracheal intubation, after mouth gag insertion, 30 minutes after mouth gag insertion and mouth gag while still in the mouth
Secondary outcome [2] 343989 0
Change in heart rate by using electrocardiogram on the anesthesia workstation
Timepoint [2] 343989 0
After general anaesthesia induction, after endotracheal intubation, after mouth gag insertion, 30 minutes after mouth gag insertion
Secondary outcome [3] 351473 0
The relationship between the optic nerve sheath diameter and the angle between the Frankfurt plane and horizantal plane of the operation table in natural position as calculated by using an application (Angles in Photos, 2015 kublaidos) after mouth gag insertion
Timepoint [3] 351473 0
After mouth gag insertion

Eligibility
Key inclusion criteria
Patients aged between 3-18 and with an ASA physical status I-II and undergoing tonsillectomy or adenotonsillectomy will be included to the study.
Minimum age
3 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be preexisting acute or chronic eye disease, history of eye surgery, use of drugs known to influence intraocular pressure (IOP) (ß blockers, Ca channel blockers, statins and nitrates) patients' parental refusal.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9480 0
Turkey
State/province [1] 9480 0
Mugla

Funding & Sponsors
Funding source category [1] 298155 0
Hospital
Name [1] 298155 0
Mugla Sitki Kocman University Training and Research Hospital
Address [1] 298155 0
Kotekli Mahalllesi Mugla Sitki Kocman University Training and Research Hospital, Anesthesiology and Reanimation Department,48001, Mugla, Turkey
Country [1] 298155 0
Turkey
Primary sponsor type
Individual
Name
BASAK ALTIPARMAK
Address
Kötekli Mahallesi Mugla Sitki Kocman University Training and Research Hospital, Anesthesiology and Reanimation Department, Mugla, 48001, Turkey
Country
Turkey
Secondary sponsor category [1] 297245 0
None
Name [1] 297245 0
Address [1] 297245 0
Country [1] 297245 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299170 0
MUGLA SITKI KOCMAN UNIVERSITY ETHICS COMMITTEE
Ethics committee address [1] 299170 0
Kötekli mahallesi, Mugla Sitki Kocman University Scientific Researches Ethics Committee Secretariat Mugla, 48001, Turkey
Ethics committee country [1] 299170 0
Turkey
Date submitted for ethics approval [1] 299170 0
02/10/2017
Approval date [1] 299170 0
02/03/2018
Ethics approval number [1] 299170 0

Summary
Brief summary
Our aim is to evaluate changes in the optic nerve sheath diameter (ONSD) in patients undergoing tonsillectomy adenoidectomy/tonsillectomy surgery while mouth gag is opened at the mouth.After obtaining approval from the Mugla Sitki Kocman Scientific
Clinical Researches Ethics Committee 40 patients, 3 to 18 years old with an American
Society of Anesthesiologists physical status of I and II scheduled
for tonsillectomy, adenoidectomy, tonsiladenoidectomy will be enrolled into the study. Patients with the following conditions will be excluded: hypertension, preexisting acute
or chronic eye disease, history of eye surgery, use of drugs known to influence IOP, expected duration of mouth gag opening <30 min. ONSD will be measured in all patients
by an anesthesiologist trained in this
procedure. With the patient supine horizontally, a two-dimensional
axial cross-sectional view of the ONSD will be obtained by
positioning a 12-MHz transducer transversely on a single closed eyelid. On the
ultrasound monitor, the ONSD will be measured 3 mm posterior
to the orbital globe. Each measurement will be
performed on the same orbit.
ONS diameter measurements will be compared at four time frames (after anesthesia induction, after tracheal intubation, after mouth gag application, 30 minutes after application. The baseline ONSD and the measurements at the time frames will be compared. In addition end tidal CO2 and mean arterial pressure will be assessed and recorded for every time point.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79530 0
A/Prof BASAK ALTIPARMAK
Address 79530 0
Kotekli Mahallesi Mugla Sitki Kocman University Training And Research Hospital Anesthesiology and Reanimation Department, Mugla, 48001, Turkey
Country 79530 0
Turkey
Phone 79530 0
+905326726533
Fax 79530 0
Email 79530 0
basak_ugurlu@yahoo.com
Contact person for public queries
Name 79531 0
A/Prof BASAK ALTIPARMAK
Address 79531 0
Kotekli Mahallesi Mugla Sitki Kocman University Training And Research Hospital Anesthesiology and Reanimation Department, Mugla, 48001, Turkey
Country 79531 0
Turkey
Phone 79531 0
+905326726533
Fax 79531 0
Email 79531 0
basak_ugurlu@yahoo.com
Contact person for scientific queries
Name 79532 0
Dr MELIKE KORKMAZ TOKER
Address 79532 0
Kotekli Mahallesi Mugla Sitki Kocman University Training And Research Hospital Anesthesiology and Reanimation Department, Mugla, 48001, Turkey
Country 79532 0
Turkey
Phone 79532 0
+905054747098
Fax 79532 0
+905054747099
Email 79532 0
meltoker@gmail.com

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary