NCT06376929

Brief Summary

The correlation between preoperative oral carbohydrate intake and intraoperative random blood sugar and also the effect on postoperative nausea and vomiting.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

April 17, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

April 17, 2024

Last Update Submit

April 23, 2024

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • Mean values of Intraoperative random blood sugar in mg/dl

    Mean values of Intraoperative random blood sugar in mg/dl

    3 months

Study Arms (2)

oral carbohydrate group

ACTIVE COMPARATOR
Other: oral carbohydrate containing fluid

control group

PLACEBO COMPARATOR
Other: oral carbohydrate containing fluid

Interventions

oral carbohydrate containing fluidOTHER

administration of oral carbohydrate fluid and assessment of intraoperative blood glucose level and postoperative nausea and vomiting

control grouporal carbohydrate group

Eligibility Criteria

Age3 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Males and females
  • years to 9 years
  • Undergoing ophthalmic surgeries
  • ASA I -II

You may not qualify if:

  • Parent refusal
  • Age \<3 or \>9
  • Underlying proemetic disease
  • Positive history of Postoperative nausea and vomiting in patient, parent or sibling
  • Currently on antiemetic medications
  • History of juvenile diabetes
  • Lengthy operations more than 3 hours
  • intraoperative Blood transfusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Central Study Contacts

Hala El Sabbagh

CONTACT

01005207896halaelsabbagh@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Model Details: randomized controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

April 17, 2024

First Posted

April 22, 2024

Study Start

May 1, 2024

Primary Completion

August 1, 2024

Study Completion

September 1, 2024

Last Updated

April 25, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share