Back to resultsEffect of Adding Dexamethasone to Intrathecal Bupivacaine on Blood Sugar of Patients Undergoing Diabetic Foot Surgeries
Primary Purpose
Diabetic Foot
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine with dexamethasone
Bupivacaine
Sponsored by
About this trial
This is an interventional other trial for Diabetic Foot
Eligibility Criteria
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
Sites / Locations
- Assiut University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
group 1
group 2
Arm Description
intathecal bupivacaine
intrathecal bupivacaine with dexamethasone
Outcomes
Primary Outcome Measures
blood sugar
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03871049
Brief Title
Effect of Adding Dexamethasone to Intrathecal Bupivacaine on Blood Sugar of Patients Undergoing Diabetic Foot Surgeries
Official Title
Effect of Adding Dexamethasone to Intrathecal Bupivacaine on Blood Sugar of Patients Undergoing Diabetic Foot Surgeries.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
July 12, 2021 (Actual)
Study Completion Date
September 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
effect of intrathecal dexamethasone on blood sugar of dietetic patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Placebo Comparator
Arm Description
intathecal bupivacaine
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
intrathecal bupivacaine with dexamethasone
Intervention Type
Drug
Intervention Name(s)
Bupivacaine with dexamethasone
Intervention Description
bupivacaine with dexamethasone
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
bupivacaine
Primary Outcome Measure Information:
Title
blood sugar
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Effect of Adding Dexamethasone to Intrathecal Bupivacaine on Blood Sugar of Patients Undergoing Diabetic Foot Surgeries
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