Effect of Caudal Block Injection Rate on Optic Nerve Sheath Diameter in Pediatric Surgeries

August 20, 2024 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

Completed

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 (Actual)

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 Locations

  • Turkey
    • Sisli
      • İstanbul, Sisli, Turkey, 34400
        • Prof. Dr. Cemil Tascioglu City Hospital

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
Procedure: caudal block rate
optic nerve sheath diameter measurement according to caudal block rate
0.5ml/sec dose
Procedure: caudal block rate
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.

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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 (Actual)

February 5, 2024

Study Registration Dates

First Submitted

December 17, 2023

First Submitted That Met QC Criteria

December 17, 2023

First Posted (Actual)

January 3, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

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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