NCT04193280

Brief Summary

The aim of this study is to investigate the effect of fasting time and blood glucose levels on postoperative agitations in pediatric patients who will undergo outpatient surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

7 months

First QC Date

December 4, 2019

Last Update Submit

December 8, 2019

Conditions

Postoperative Delirium

Keywords

Preoperative fasting time,Blood glucose levelPostoperative Delirium

Outcome Measures

Primary Outcomes (3)

  • Blood sugar level

    Blood glucose levels will be measured in pediatric patients who will undergo outpatient surgery.

    11.1.2019-5.31.2020

  • The fasting time

    Fasting time will be recorded.

    11.1.2019-5.31.2020

  • The change in blood sugar level

    According to the type of operation, the change in blood sugar level will be detected. Correlation of this change with postoperative agitation will be investigated

    11.1.2019-5.31.2020

Eligibility Criteria

Age18 Months - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The study will include children between 2-12 years of age who will be operated in the pediatric operating room. Circumcision, inguinal hernia, undescended testis, lymphadenopathy excision, cystoscopy, adenotonsillectomy cases will be included in the study.

You may qualify if:

  • Pediatric patients between 2-12 years of age who will undergo outpatient surgery

You may not qualify if:

  • ASA III-IV patients, patients with congenital malformation and developmental delays, or any neurological or cardiac diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul MU Goztepe Training and Research Hospital

Istanbul, 34730, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood for blood sugar level

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Zeynep N Orhon, MD

    Istanbul Medeniyet University Goztepe Research and Traininig Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeynep N Orhon, MD

CONTACT

02165664000zeynepnurorhon@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 4, 2019

First Posted

December 10, 2019

Study Start

November 1, 2019

Primary Completion

May 31, 2020

Study Completion

June 30, 2020

Last Updated

December 10, 2019

Record last verified: 2019-12

Locations

TU(1)