Intraoperative Dexamethasone and Its Effect on Hyperglycemia

January 19, 2021 updated by: Tarik Wasfie, MD, Ascension Genesys Hospital

Effect of Pre-Operative Dexamethasone Dose on the Post-Operative Management of Blood Sugar in Diabetic Patients

To study the effect of intra-operative dexamethasone on the management of post-operative blood sugar in diabetic patients.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Genesys Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • documented history of Type I or Type II Diabetes Mellitus
  • scheduled for surgery that requires patients to be admitted for at least 24 hours post-surgery

Exclusion Criteria:

  • Patients on steroid therapy
  • Pregnant women
  • Patients at low risk for nausea/vomiting

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone
Drug: Dexamethasone
Gluco-corticosteroid
Other: No dexamethasone
Nothing
No Intervention: Non-treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post-operative blood sugar
Time Frame: 24 hour Post surgery
24 hour Post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascension Genesys Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

August 23, 2018

First Submitted That Met QC Criteria

August 23, 2018

First Posted (Actual)

August 24, 2018

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 19, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRMC160010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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