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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06187714
Other study ID # 681429
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 5, 2023
Est. completion date February 5, 2024

Study information

Verified date December 2023
Source Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
Contact onur karaoglu
Phone 05056814224
Email rasimonurkaraoglu@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Our prospective observational study will include patients between the ages of 1-7 years, ASA 1-2, who will undergo elective surgery under general anesthesia, whose consent was obtained by their parents for the procedure to be performed. Optic nerve sheath diameter of the patients will be measured and recorded.


Description:

The study will be conducted with patients who will undergo elective surgery and caudal block will be applied between 05.07.2023-05.09.2023 in the Anesthesiology and Reanimation Clinic of Prof. Dr. Cemil Taşçıoğlu City Hospital after Ethics Committee approval and written and verbal consent of the patients. Our prospective observational study will include patients between the ages of 1-7 years, ASA 1-2, who will undergo elective surgery under general anesthesia, whose consent was obtained by their parents for the procedure to be performed. Gender, age, weight, height, body mass index (BMI), ASA (American Society of Anesthesiology) score and medical history of the patients will be recorded. Injection times of pediatric patients who underwent caudal block with 0.125% bupivacaine at a dose of 0.8 ml/kg using a 22 gauge caudal needle will be noted. Optic nerve sheath diameter of the patients will be measured and recorded. Intraoperative hemodynamic parameters, postoperative complications (nausea, vomiting, urinary retention) will also be noted.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date February 5, 2024
Est. primary completion date October 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 7 Years
Eligibility Inclusion Criteria: Patients aged 1-7 years, ASA 1-2, who will undergo elective surgery under general anesthesia, in whom consent has been obtained for the procedure to be performed Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
caudal block rate
optic nerve sheath diameter measurement according to caudal block rate

Locations

Country Name City State
Turkey Prof. Dr. Cemil Tascioglu City Hospital Istanbul Sisli

Sponsors (1)

Lead Sponsor Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other optic nerve sheath diameter measurement optic nerve sheath diameter 20th minute after caudal block
Primary optic nerve sheath diameter measurement optic nerve sheath diameter 1st minute after caudal block
Secondary optic nerve sheath diameter measurement optic nerve sheath diameter 10th minute after caudal block
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