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CompletedNCT06187714Updated Aug 21, 2024

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

An observational study in Optic Nerve Sheath Diameter and Caudal Block, sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization. Completed at 1 site in Turkey. Open to participants aged 1 Year to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-21.

Sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
1 Year to 7 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Optic Nerve Sheath Diameter
  • Caudal Block
03

In context

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization is the lead sponsor of 84 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 7 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

pediatric patients aged 1-7 years for caudal block

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

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • 0.25ml/sec

    Procedure: caudal block rate

  • 0.5ml/sec dose

    Procedure: caudal block rate

Interventions

  • Procedurecaudal block rate

    optic nerve sheath diameter measurement according to caudal block rate

06

What researchers measure

Primary outcomes

  1. optic nerve sheath diameter measurement

    optic nerve sheath diameter

    Time frame: 1st minute after caudal block

Secondary outcomes

  1. optic nerve sheath diameter measurement

    optic nerve sheath diameter

    Time frame: 10th minute after caudal block

Other outcomes

  1. optic nerve sheath diameter measurement

    optic nerve sheath diameter

    Time frame: 20th minute after caudal block

07

Study locations

1 site
  • Prof. Dr. Cemil Tascioglu City Hospital
    İstanbul, Sisli 34400, Turkey
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06187714
Lead sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Responsible party
Rasim Onur Karaoglu (MD, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization) — Principal investigator
First posted
Jan 3, 2024
Start date
Jul 5, 2023
Primary completion
Oct 5, 2023
Completion
Feb 5, 2024
Last update
Aug 21, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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