Effect of Adding Dexamethasone to Intrathecal Bupivacaine on Blood Sugar of Patients Undergoing Diabetic Foot Surgeries

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03871049
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.2
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

effect of intrathecal dexamethasone on blood sugar of dietetic patients

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot	Drug: Bupivacaine with dexamethasone; Drug: Bupivacaine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Effect of Adding Dexamethasone to Intrathecal Bupivacaine on Blood Sugar of Patients Undergoing Diabetic Foot Surgeries.
• Actual Study Start Date: Jan 10, 2020
• Actual Primary Completion Date: Jul 12, 2021
• Actual Study Completion Date: Sep 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: group 1 intathecal bupivacaine	Drug: Bupivacaine; bupivacaine
Active Comparator: group 2 intrathecal bupivacaine with dexamethasone	Drug: Bupivacaine with dexamethasone; bupivacaine with dexamethasone

Outcome Measures

Primary Outcome Measures

1. blood sugar [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• control diabetic patients will undergo foot surgeries.

Exclusion Criteria:

• The exclusion criteria included patient refusal, patients with major cardiac, respiratory, renal, hepatic disorders or uncontrolled diabetes mellitus, history of chronic use of analgesic medication or hypersensitivity to drugs under investigation, any contraindication to regional anesthesia, namely; patients with coagulopathy infection at puncture site, backache, spine deformity or prior surgery, neuromuscular disorders or psychic disturbances

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University Hospital	Assiut		Egypt

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eman A. Ismail, assistant profesor, Assiut University
• ClinicalTrials.gov Identifier: NCT03871049
• Other Study ID Numbers: 01003060566
• First Posted: Mar 12, 2019
• Last Update Posted: Feb 25, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetic Foot; Dexamethasone; Bupivacaine

Study Results

No Results Posted as of Feb 25, 2022