Liver TransplantationAgitationNCT02544906
Propofol Versus Dexmedetomidine for Prevention of Sevoflurane Agitation in Recipients of Living Donor Liver Transplantation
A study testing Propofol and dexmedetomedine in people with Liver Transplantation, run by AlRefaey Kandeel at 1 site in Egypt.
Trial summary
The use of propofol or dexmedetomedine for prevention of sevofurane emergence agitation in LDLT recipients Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Propofol and dexmedetomedine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All recipients of living donor liver transplantation
Who cannot join
- patient refusal Allergy to either propofol or dexmedetomediene CNS disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura university
Al Mansurah, Dkahleya
Alreafey Kandeel, MD, 00201008158591, refa3ey2@yahoo.com
About this study
The use of propofol or dexmedetomedine for prevention of sevofurane emergence agitation in LDLT recipients
- Conditions
- Liver Transplantation
- Being tested
- Propofol, dexmedetomedine
- Keywords
- recipients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Infusion of propofol to prevent emergence agitation in liver transplanta recipients
dexmedetomedineDrug
Infusion of dexmedetomedine to prevent emergence agitation in liver transplanta recipients
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: dexmedetomedine |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of emergence agitation in liver trasnplant recipients
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AlRefaey Kandeel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, AlRefaey Kandeel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544906
- Sponsor's protocol ID
- LTx 7
- Acronym
- Agitation
- Status last verified
- Sep 2015
- First submitted
- 7 Sep 2015
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol Versus Dexmedetomidine for Prevention of Sevoflurane Agitation in Recipients of Living Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT02544906
- Acronym / sponsor ID
- Agitation / LTx 7
- Conditions
- Liver Transplantation
- Keywords
- recipients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- AlRefaey KandeelUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of propofol or dexmedetomedine for prevention of sevofurane emergence agitation in LDLT recipients
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No drugs will be given. the emergence agitation will be monitored and recorded |
| Propofol group | Experimental | Drug: PropofolPropofol at dose of 1 mg/kg over 5 minutes will be started before extubation. the emergence agitation will be monitored and recorded |
| dexmedetomedine group | Experimental | Drug: dexmedetomedinedexmedetomedine at dose of .5 mic/kg over 5 minutes will be started before extubation. the emergence agitation will be monitored and recorded |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All recipients of living donor liver transplantation
Key exclusion criteria (1 listed)
- patient refusal Allergy to either propofol or dexmedetomediene CNS disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolInfusion of propofol to prevent emergence agitation in liver transplanta recipients | Drug | Propofol group |
| dexmedetomedineInfusion of dexmedetomedine to prevent emergence agitation in liver transplanta recipients | Drug | dexmedetomedine group |
Primary outcome
incidence of emergence agitation in liver trasnplant recipients
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and dexmedetomedine in people with Liver Transplantation, run by AlRefaey Kandeel at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of emergence agitation in liver trasnplant recipients (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2015.