NCT03307590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

3 months

First QC Date

August 20, 2017

Last Update Submit

July 16, 2018

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Pain relief

    CHEOPS scale value

    6 months study

Study Arms (2)

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

DexmedetomidineDRUG

Caudal block by dexmedetomidine and bupivavaine

Also known as: Precedex
D group
BupivacaineDRUG

Caudal block by bupivavaine alone

Also known as: Marcaine
B group

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • supra - umbilical surgeries

You may not qualify if:

  • allergy to the drug or coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

DexmedetomidineBupivacaine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

August 20, 2017

First Posted

October 11, 2017

Study Start

October 1, 2017

Primary Completion

December 30, 2017

Study Completion

December 30, 2017

Last Updated

July 17, 2018

Record last verified: 2018-07

Locations

EG(1)