NCT06915493

Brief Summary

This cross-sectional study aims to investigate blood glucose levels in children during general anesthesia and explore the incidence of hypoglycemia after anesthesia induction in relation to preoperative fasting. Blood glucose will be measured following anesthesia induction and prior to discontinuing the administration of the anesthetic agent.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2025

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

1.4 years

First QC Date

March 31, 2025

Last Update Submit

April 8, 2025

Conditions

Fasting

Keywords

PediatricsChildrenGeneral anesthesiaPreoperative fastingFasting blood glucoseHypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Serum blood glucose level

    Blood glucose sampling and measured during general anesthesia

    Immediately/within five minutes after anesthesia induction and prior to discontinuing the anesthesia administration.

Interventions

General AnesthesiaOTHER

Blood glucose measurements during general anesthesia

Eligibility Criteria

Age1 Day - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Convenience sample of children undergoing elective intervention under general anesthesia at Landspítali, the University Hospital of Iceland.

You may qualify if:

  • Children under 18 years of age who undergo intervention under general anesthesia. The parent or guardian understands and speaks Icelandic.

You may not qualify if:

  • Coexisting disease or treatment that may affect fasting blood glucose level; Preoperative intravenous fluid administration; Beta-blockers; Insulin and corticosteroids, endocrine disorders, acute pain, and emergency interventions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesia Department Landspitali UH

Reykjavik, 101, Iceland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Capillary blood sample glucose

MeSH Terms

Conditions

FastingHypoglycemia

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Thorunn S Eliasdottir, PhD

    Landspitali, the University Hospital of Iceland and University of Iceland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic chair, Associate Professor

Study Record Dates

First Submitted

March 31, 2025

First Posted

April 8, 2025

Study Start

October 1, 2023

Primary Completion

March 3, 2025

Study Completion

March 3, 2025

Last Updated

April 11, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
May 2025 - December 2026

Locations

IC(1)