Effect of Adding Dexamethasone to Intrathecal Bupivacaine... | NCT03871049

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

NCT03871049

Sponsor

Assiut University

Status

Completed

Last Update Posted

Feb 25, 2022Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Diabetic Foot

Interventions

Bupivacaine with dexamethasone
Bupivacaine

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2020Actual

Primary Completion Date

Jul 12, 2021Actual

Completion Date

Sep 17, 2021Actual

First Submitted Date

Mar 10, 2019

First Submission Date that Met QC Criteria

Mar 11, 2019

First Posted Date

Mar 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2022

Last Update Posted Date

Feb 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group 1	Placebo Comparator	intathecal bupivacaine	Drug: Bupivacaine
group 2	Active Comparator	intrathecal bupivacaine with dexamethasone	Drug: Bupivacaine with dexamethasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bupivacaine with dexamethasone	Drug	bupivacaine with dexamethasone	group 2

Measure	Description	Time Frame
blood sugar		24 hours

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University Hospital		Asyut			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D017719	Diabetic Foot

Ancestor Terms

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine
D003907	Dexamethasone

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided