Intraoperative Dexamethasone and Its Effect on Hyperglycemia

• Sponsor: Ascension Genesys Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03646916
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Drug: Dexamethasone; Other: No dexamethasone	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Effect of Pre-Operative Dexamethasone Dose on the Post-Operative Management of Blood Sugar in Diabetic Patients
• Actual Study Start Date: Sep 15, 2020
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Post-operative blood sugar [24 hour Post surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Genesys Regional Medical Center	Grand Blanc	Michigan	United States	48439

Sponsors and Collaborators

• Ascension Genesys Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tarik Wasfie, MD, Principal Investigator, Ascension Genesys Hospital
• ClinicalTrials.gov Identifier: NCT03646916
• Other Study ID Numbers: GRMC160010
• First Posted: Aug 24, 2018
• Last Update Posted: Jan 22, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101

Study Results

No Results Posted as of Jan 22, 2021