NCT06187714

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

December 17, 2023

Last Update Submit

August 20, 2024

Conditions

Optic Nerve Sheath DiameterCaudal Block

Outcome Measures

Primary Outcomes (1)

  • optic nerve sheath diameter measurement

    optic nerve sheath diameter

    1st minute after caudal block

Secondary Outcomes (1)

  • optic nerve sheath diameter measurement

    10th minute after caudal block

Other Outcomes (1)

  • optic nerve sheath diameter measurement

    20th minute after caudal block

Study Arms (2)

0.25ml/sec

Procedure: caudal block rate

0.5ml/sec dose

Procedure: caudal block rate

Interventions

caudal block ratePROCEDURE

optic nerve sheath diameter measurement according to caudal block rate

0.25ml/sec0.5ml/sec dose

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

pediatric patients aged 1-7 years for caudal block

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, Sisli, 34400, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 17, 2023

First Posted

January 3, 2024

Study Start

July 5, 2023

Primary Completion

October 5, 2023

Study Completion

February 5, 2024

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

TU(1)