NCT02531529

Brief Summary

To compare between the analgesic effect of dexmedetomedine infusion versus Fentanyl infusion during donor hepatectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

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

Study Start

First participant enrolled

January 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2015

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

1.2 years

First QC Date

August 20, 2015

Last Update Submit

August 21, 2015

Conditions

Donor Hepatectomy

Outcome Measures

Primary Outcomes (1)

  • postoperative VAS scale

    3 days

Study Arms (2)

D group

EXPERIMENTAL

intraoperative dexmedetomedine infusion

Drug: dexmedetomedine

F group

SHAM COMPARATOR

Intraoperative fentanyl infusion

Drug: Fentanyl

Interventions

dexmedetomedineDRUG

intraoperative infusion

D group
FentanylDRUG
F group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • donors of living donor liver transplantation

You may not qualify if:

  • patient refusal Known allergy to dexmedetomedine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university

Al Mansurah, Dkahleya, Egypt

Location

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 20, 2015

First Posted

August 24, 2015

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

August 24, 2015

Record last verified: 2015-08

Locations

EG(1)