- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06187714
Effect of Caudal Block Injection Rate on Optic Nerve Sheath Diameter in Pediatric Surgeries
December 17, 2023 updated by: Rasim Onur Karaoglu, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: onur karaoglu
- Phone Number: 05056814224
- Email: rasimonurkaraoglu@hotmail.com
Study Locations
-
-
Sisli
-
İstanbul, Sisli, Turkey, 34400
- Recruiting
- Prof. Dr. Cemil Tascioglu City Hospital
-
Contact:
- onur karaoglu
- Phone Number: 05056814224
- Email: rasimonurkaraoglu@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
pediatric patients aged 1-7 years for caudal block
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
0.25ml/sec
|
optic nerve sheath diameter measurement according to caudal block rate
|
0.5ml/sec dose
|
optic nerve sheath diameter measurement according to caudal block rate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
optic nerve sheath diameter measurement
Time Frame: 1st minute after caudal block
|
optic nerve sheath diameter
|
1st minute after caudal block
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
optic nerve sheath diameter measurement
Time Frame: 10th minute after caudal block
|
optic nerve sheath diameter
|
10th minute after caudal block
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
optic nerve sheath diameter measurement
Time Frame: 20th minute after caudal block
|
optic nerve sheath diameter
|
20th minute after caudal block
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 5, 2023
Primary Completion (Actual)
October 5, 2023
Study Completion (Estimated)
February 5, 2024
Study Registration Dates
First Submitted
December 17, 2023
First Submitted That Met QC Criteria
December 17, 2023
First Posted (Estimated)
January 3, 2024
Study Record Updates
Last Update Posted (Estimated)
January 3, 2024
Last Update Submitted That Met QC Criteria
December 17, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 681429
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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