NCT02544906

Brief Summary

The use of propofol or dexmedetomedine for prevention of sevofurane emergence agitation in LDLT recipients

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

1.1 years

First QC Date

September 7, 2015

Last Update Submit

September 8, 2015

Conditions

Liver Transplantation

Keywords

recipients

Outcome Measures

Primary Outcomes (1)

  • incidence of emergence agitation in liver trasnplant recipients

    24 hours

Study Arms (3)

Control

NO INTERVENTION

No drugs will be given. the emergence agitation will be monitored and recorded

Propofol group

EXPERIMENTAL

Propofol at dose of 1 mg/kg over 5 minutes will be started before extubation. the emergence agitation will be monitored and recorded

Drug: Propofol

dexmedetomedine group

EXPERIMENTAL

dexmedetomedine at dose of .5 mic/kg over 5 minutes will be started before extubation. the emergence agitation will be monitored and recorded

Drug: dexmedetomedine

Interventions

PropofolDRUG

Infusion of propofol to prevent emergence agitation in liver transplanta recipients

Propofol group
dexmedetomedineDRUG

Infusion of dexmedetomedine to prevent emergence agitation in liver transplanta recipients

dexmedetomedine group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All recipients of living donor liver transplantation

You may not qualify if:

  • patient refusal Allergy to either propofol or dexmedetomediene CNS disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university

Al Mansurah, Dkahleya, Egypt

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

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
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 7, 2015

First Posted

September 9, 2015

Study Start

September 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

September 9, 2015

Record last verified: 2015-09

Locations

EG(1)