Comparing Dexmedetomidine With Bupivacaine Versus Bupivac... | NCT03307590

Studies
Comparing Dexmedetomidine With Bupivacaine Versus Bupivacaine Alone for Caudal Block in Supra - Umbilical Surgeries

NCT03307590

Sponsor

Cairo University

Status

Completed

Last Update Posted

Jul 17, 2018Actual

Enrollment

24Actual

Phase

Phase 2Phase 3

Conditions

Anesthesia

Interventions

Dexmedetomidine
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

Jul 2018

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

Oct 1, 2017Actual

Primary Completion Date

Dec 30, 2017Actual

Completion Date

Dec 30, 2017Actual

First Submitted Date

Aug 20, 2017

First Submission Date that Met QC Criteria

Oct 6, 2017

First Posted Date

Oct 11, 2017Actual

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

Jul 16, 2018

Last Update Posted Date

Jul 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

dexmedetomidine is an alpha 2 adrenergic receptor agonist that is given either systemically or combined to local anesthetics during regional blocks. Investigators studied the combination of dexmedetomedine/bupivacaine versus bupivacaine alone for caudal blockage in pediatric patients undergoing supra - umbilical surgeries.

Detailed Description

Dexmedetomidine was combined to bupivavaine and administered via caudal route to be compared to caudal bupivavaine alone for analgesia following upper trunk surgery

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
D group	Active Comparator	Dexmedetomidine with bupivacaine group Caudal dexmedetomidine 1.5 microgram/kg with bupivavaine (0.25%) 1.25 ml/kg were administered	Drug: Dexmedetomidine
B group	Active Comparator	Bupivacaine only group Caudal bupivavaine (0.25%) 1.25 ml/kg without dexmedetomidine was administered	Drug: Bupivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug	Caudal block by dexmedetomidine and bupivavaine	D group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain relief	CHEOPS scale value	6 months study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

supra - umbilical surgeries

Exclusion Criteria:

allergy to the drug or coagulopathy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine
D002045	Bupivacaine

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided