Hydroxyzine Dihydrochloride Premedication is a Necessity for Strabismus Surgery

NCT03806270 | Completed Results FDA Drug

• 1 other identifier: KAEK884
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

Oculocardiac reflex (OCR) is usually happening in pediatric strabismus surgery and observed just when the surgent pulls the ocular muscles. The reflex is one of the trigemino-vagal reflexes, and causes bradycardia, arrhythmia, and even cardiac arrest during eye surgery. Premedication for relaxation with drugs like hydroxyzine dihydrochloride or midazolam before surgery of the pediatric population is often used in Turkey, although it is not recommended in foreign countries. Some recent studies showed that when midazolam and hydroxyzine dihydrochloride used together not only, they lessen agitation before surgery but also they prevent emergence agitation. The primary aim of this prospective observational study is to show the effect of hydroxyzine dihydrochloride on preventing the pediatric patient from Oculocardiac reflex related to strabismus surgery.

Conditions

Strabismus; Reflex, Oculocardiac; Hydroxyzine; Bradycardia Sinus

Keywords

Strabismus surgery; Oculocardiac reflex; Hydroxyzine dihydrochloride; Midazolam; Premedication; The Ramsay Scale

Outcome Measures

Primary Outcomes (4)

• Heart Rate-1

  The lowest heart rate observed from EKG monitorization at the "time-out" after the anesthesia induction, and just before the surgery starts. Heart rate-1 is a data, not an assessing change, which is recoded during the "time-out". "The time-out" is when the patient's name, the procedure, the surgent name is repeated before the operation starts.

  1 minute, at the "time out", through study completion an average of 6 months

• Heart Rate-2

  The heart rate observed from EKG monitorization at the time operator warns the investigator just before the traction of the orbital muscle. Heart rate-2 is a data, not an assessing change, which is recorded during the operation at the time operator warns. The heart rate observed from EKG monitorization, before every orbital muscle traction at the time the operator's warning before traction.

  1 minute, at the strabismus surgery operation, through study completion an average of 6 months

• Heart Rate-3

  The lowest heart rate observed from EKG monitorization, after every orbital muscle traction within 120 seconds. Heart rate-3 is a data, not an assessing change, which is recorded within 120 seconds after traction applied.

  within 120 seconds after the orbital muscle traction, at the strabismus surgery operation, through study completion an average of 6 months

• Number of Observed Oculocardiac Reflex(OCR)

  The OCR is a heartbeat anomaly(bradycardia, any arrhythmia, or cardiac arrest) associated with traction applied to the extraocular muscles during strabismus surgery. The specific criteria were as follows: the lowest heart rate observed within 120 seconds from EKG monitorization, after every orbital muscle traction, was less than 20% of the heart rate observed directly preceding traction of the orbital muscle. Additionally, any kind of arrhythmia or cardiac arrest occurrence within 120 seconds after orbital muscle traction was also defined as an OCR.

  2 minutes, at the strabismus surgery operation after recording Heart Rate-3, through study completion an average of 6 months

Secondary Outcomes (1)

• Ramsay Sedation Score

  After patient transferred into the operation theatre and before anesthesia induction, through study completion an average of 6 months

Other Outcomes (2)

• Number of Orbital Muscles of the Participants With Different Considerations Taken With Respect to the Treatment of OCR

  within 5 minutes after defining the OCR occurrence, at the strabismus surgery operation, through study completion an average of 6 months

• The Orbital Muscle Name Which OCR Occurred During it's Traction

  within 5 minutes after defining the OCR occurrence, at the strabismus surgery operation, through study completion an average of 6 months

Study Arms (3)

Midazolam

Demizolam, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with cherry juice of maximum 5 ml. in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication and doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively.

Drug: Midazolam

Midazolam&Hydroxyzine dihydrochloride1/2

Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with hydroxyzine dihydrochloride (dose of 0.5 mg/kg) in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively.

Drug: Midazolam; Drug: Hydroxyzine Dihydrochloride

Midazolam&Hydroxyzine dihydrochloride

Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with the maximum dose of 1mg/kg hydroxyzine dihydrochloride in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively.

Drug: Midazolam; Drug: Hydroxyzine Dihydrochloride

Interventions

Midazolam DRUG

Demizolam 15mg/ml ampules, given orally with cherry juice

Also known as: Dormicum,8699505751689,N05CD08, Demizolam,8699769750077,N05CD08, Zolamide,8680184750025,N05CD08

Midazolam; Midazolam&Hydroxyzine dihydrochloride; Midazolam&Hydroxyzine dihydrochloride1/2

Hydroxyzine Dihydrochloride DRUG

Atarax 2mg/ml syrup, given orally

Also known as: ATARAX 200 ml syrup,8699624570062,N05BB01, VALIDOL,8699705590019,N05BB01

Midazolam&Hydroxyzine dihydrochloride; Midazolam&Hydroxyzine dihydrochloride1/2

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients aged between 1 to 10 years who are diagnosed as strabismus or esotropia, and scheduled for strabismus surgery.

You may qualify if:

• Strabismus, surgery needed
• Esotropia, surgery needed

You may not qualify if:

• Chronic disease
• Arrhythmia
• Glaucoma(narrow-angle)

Sponsors & Collaborators

• Yeditepe University: lead

Study Sites (2)

Yeditepe University Ophtalmology Research Center

Istanbul, Beşiktaş, 34349, Turkey (Türkiye)

Location

Yeditepe University Hospital

Istanbul, İçerenköy, Turkey (Türkiye)

Location

Related Publications (3)

• Oh JN, Lee SY, Lee JH, Choi SR, Chin YJ. Effect of ketamine and midazolam on oculocardiac reflex in pediatric strabismus surgery. Korean J Anesthesiol. 2013 Jun;64(6):500-4. doi: 10.4097/kjae.2013.64.6.500. Epub 2013 Jun 24.

  PMID: 23814649 BACKGROUND

• Koner O, Ture H, Mercan A, Menda F, Sozubir S. Effects of hydroxyzine-midazolam premedication on sevoflurane-induced paediatric emergence agitation: a prospective randomised clinical trial. Eur J Anaesthesiol. 2011 Sep;28(9):640-5. doi: 10.1097/EJA.0b013e328344db1a.

  PMID: 21822077 BACKGROUND

• Kartufan FF, Kizilcik N, Ziylan S, Menda F. Hydroxyzine Dihydrochloride Premedication Is a Necessity for Pediatric Patients Undergoing Strabismus Surgery: An Observational Prospective Clinical Trial. J Ophthalmol. 2022 Sep 21;2022:4137144. doi: 10.1155/2022/4137144. eCollection 2022.

  PMID: 36189149 DERIVED

MeSH Terms

Conditions

Strabismus

Interventions

Midazolam; Hydroxyzine; Validol

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperazines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

this current trial is not a prospective randomized study

Results Point of Contact

• Title: Dr. Ferda F. Kartufan
• Organization: Yeditepe U

ferdasozer@gmail.com

+902165784000

Study Officials

• Ferda F Kartufan, Assist.Prof

  Yeditepe University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 24, 2018
• First Posted: January 16, 2019
• Study Start: October 1, 2018
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: October 22, 2019
• Results First Posted: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)