Anesthesia of Living Donor HepatectomyEtCntrlNCT02676934
End Tidal Control of Sevoflurane
A study of Anesthesia of Living Donor Hepatectomy, run by Mansoura University at 1 site in Egypt.
Trial summary
the study compares the use of end tidal (Et) control of sevoflurane during anesthesia for living donor hepatectomy versus fresh gas (FGF) control. Et control is hypothesized to be as effective as FGF control with less cost and more operator satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anesthesia of Living Donor Hepatectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Jan 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- all donors scheduled for living donor hepatectomy in Mansoura liver transplant program
Who cannot join
- refusal
Trial locations and contacts
1 site in 1 country.
About this study
the study compares the use of end tidal (Et) control of sevoflurane during anesthesia for living donor hepatectomy versus fresh gas (FGF) control. Et control is hypothesized to be as effective as FGF control with less cost and more operator satisfaction.
- Conditions
- Anesthesia of Living Donor Hepatectomy
- Being tested
- End tidal control module in Aisys anesthesia workstation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End tidal control module in Aisys anesthesia workstationDevice
THE USE OF AUTOMATED CONTROL OF END TIDAL SEVOFLURANE CONCENTRATION TO MAINTAIN ANESTHESIA DURING DONOR HEPATECTOMY
| Study group | Role | What they receive |
|---|---|---|
| Et group | Experimental | applying end tidal concentration as a control target for delivery of sevoflurane Receives: Device: End tidal control module in Aisys anesthesia workstation |
| FGF group | No intervention | using Fresh gas control for sevoflurane delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
cost of sevoflurane during anesthesia
Measured: Intra-operative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia of Living Donor HepatectomyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AlRefaey Kandeel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676934
- Sponsor's protocol ID
- R-ETCNTRL
- Acronym
- EtCntrl
- Status last verified
- Feb 2016
- First submitted
- 1 Feb 2016
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End Tidal Control of Sevoflurane
- ClinicalTrials.gov ID
- NCT02676934
- Acronym / sponsor ID
- EtCntrl / R-ETCNTRL
- Conditions
- Anesthesia of Living Donor Hepatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 Feb 2016 (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 study compares the use of end tidal (Et) control of sevoflurane during anesthesia for living donor hepatectomy versus fresh gas (FGF) control. Et control is hypothesized to be as effective as FGF control with less cost and more operator satisfaction.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Et group | Experimental | Device: End tidal control module in Aisys anesthesia workstationapplying end tidal concentration as a control target for delivery of sevoflurane |
| FGF group | No intervention | –using Fresh gas control for sevoflurane delivery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all donors scheduled for living donor hepatectomy in Mansoura liver transplant program
Key exclusion criteria (1 listed)
- refusal
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 |
|---|---|---|
| End tidal control module in Aisys anesthesia workstationTHE USE OF AUTOMATED CONTROL OF END TIDAL SEVOFLURANE CONCENTRATION TO MAINTAIN ANESTHESIA DURING DONOR HEPATECTOMY | Device | Et group |
Primary outcome
cost of sevoflurane during anesthesia
Time frame: Intra-operative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Anesthesia of Living Donor Hepatectomy, run by Mansoura University 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: finished, as of the sponsor's last update on 9 Feb 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cost of sevoflurane during anesthesia (time frame: Intra-operative period). 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 Feb 2016.