Hydroxyzine Dihydrochloride Premedication is a Necessity for Pediatric Patients Undergoing Strabismus Surgery; An Observational Clinical Trial Controlled With Midazolam
Conditions: Strabismus, Reflex, Oculocardiac, Hydroxyzine, Bradycardia Sinus
Sponsor: Yeditepe University

 
 
 
 
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[Kurs başlığı]
Brief Title: Hydroxyzine Dihydrochloride Premedication is a Necessity for Strabismus Surgery 
 
 
Hydroxyzine Dihydrochloride Premedication is a Necessity 
for Pediatric Patients Undergoing Strabismus Surgery; An 
Observational Clinical Trial Controlled With Midazolam 
 
 
 
 
 
Document Date: OCT 1, 2018 
 
 
NCT NO: NCT03806270 
 
 
 

 
Participant Code:  
1 
 
Study Protocol 
 
1 
 
The observational study named "Hydroxyzine Dihydrochloride Premedication is a 
Necessity for Pediatric Patients Undergoing Strabismus Surgery; An Observational 
Clinical Trial Controlled With Midazolam" will be done in Yeditepe University 
Hospital and Yeditepe University Eye Center. Seventy-five pediatric patients between 
one and ten years of age are planned to be included to the study who are planned to be 
scheduled for strabismus surgery. 
 
 
Inclusion Criteria: 
 
 Strabismus, surgery needed 
 Esotropia, surgery needed 
 
Exclusion Criteria: 
 
 Chronic disease 
 Arrhythmia 
 Glaucoma(narrow-angle) 
After having the oral and written consent form from the patients and their parents 
following data will be recorded. 
 
Premedication  
The anesthesiology doctor of the patient orders oral premedication for sedation before 
surgery. Premedication ordered and utilized will be seen and recorded by the 
investigator after the strabismus surgery from the written data in the patient's file, 
retrospectively. Therefore the patients will be grouped after the statistical data were 
recorded observationally in the operation theatre during the strabismus surgery. 
 
The statistical data planned to be recorded in the operation theatre are; Ramsay 
Sedation score before surgery starts, ocular muscle name which traction performed, 
Heart Rate 1, Heart Rate 2 and Heart Rate 3, OCR occurrence, OCR treatment. 
Heart Rate-1 The lowest heart rate observed from EKG monitorization at 
the "time-out" after the anesthesia induction in one minute time.just before 
the surgery starts. Heart rate-1 is a data, not an assessing change, which 
is recoded during the "time-out".  
Heart Rate-2 The heart rate observed from EKG monitorization at the time 
operator warns the investigator just before the traction of every orbital 
muscle.  
Heart Rate-3 The lowest heart rate observed from EKG monitorization, 
after every orbital muscle traction within 120 seconds. 
   
 

 
Participant Code:  
2 
 
 
Ramsay sedation scale 
Score   
 
Response 
1 
 
 
Anxious or restless or both 
2 
 
 
Cooperative, orientated and tranquil 
3 
 
 
Responding to commands 
4 
 
 
Brisk response to stimulus 
5 
 
 
Sluggish response to stimulus 
6 
 
 
No response to stimulus 
 
 
 
 
 
HR:  Heart Rate 
 
 HR(1)  After Anesthesia induction  
 HR(2)  Before traction performed to an ocular muscle 
 HR(3)  After traction to an ocular muscle  
 
 
OCR definition  
1) HR (3), less than 20 % of HR (2)  
2) Arrhythmia or asystole occurrence after traction of an ocular muscle  
 
OCR treatment 
1)  to stop traction for a while 
2)  Atropine sulfate treatment ordered by the anesthesiology doctor of the patient 
regarding no HR response to the treatment number 1 above 
3)  Cardiac resuscitation regarding asystole or defibrillation regarding  
 
 
 

 
Participant Code:  
3 
 
 
Participant Data in the operation theatre Form 
 
Gender: 
Age: 
Height:       
Weight:         
 
 
Ramsay Sedation score ( Tick in the parenthesis) 
  
1( ) 
2( ) 
3( ) 
4( ) 
5( ) 
6( ).. 
 
 
Perioperative data   
Name of the Ocular muscle traction performed:.............................. 
HR 1: .................../dk    
HR 2: .................. /dk    
HR 3: .................../dk    
 
 If more than one  
 
Name of the Ocular muscle traction performed:.............................. 
HR 1: .................../dk    
HR 2: .................. /dk    
HR 3: .................../dk  
 
If more than two fill another form with the same participant code 
 
 
OCR: occurred  ( ) 
/ 
not occurred  ( ) 
 
If occurred;. 
 
Ocular muscle name  : 
HR(2)-rate/minute 
: 
HR(3) rate/minute 
: 
Treatment number 
: 
 
 
 
 
If occurred in more than one muscle; 
 
Ocular muscle name  : 
HR(2)-rate/minute 
: 
HR(3) rate/minute 
: 
Treatment number 
: 
 
 

 
Participant Code:  
4 
 
 
 
 
If occurred in more than two muscle fill another form with the same participant 
code 
 
 
 
Premedication ordered and utilized to the participant 
 
Group 1  ( )  PO Midazolam (0,5 mg/kg) only 
 
 
Group 2  ( )  PO Midazolam (0,5 mg/kg) and Hydroxyzine Dihydrocloride  
 
 
 
 
 
 
 
(0,5mg/kg)  
 
 
Group 3.  ( ) PO Midazolam (0,5 mg/kg) and Hydroxyzine Dihydrocloride (1mg/kg)  
 
 
 
After 36 participants  
The participants will be grouped related to the premedication utilized to them.  
There are three kinds of oral premedication are known to be ordered in the Yeditepe 
University hospital and in the Yeditepe University Eye Clinic according to our 
knowledge. If there is any other premedication ( IV or IM) ordered or utilized to the 
patients, those will not be included in the study. 
 
After reaching the same participant number in each group post hoc test (Tukey) will 
be performed and if more than one group comparison is calculated to be significantly 
different, the study will be stopped. 
If not, the study will be stopped after reaching the calculated participant number 75 
according to the power analysis done.