HepatectomyEarly Phase 1NCT05246371
Propofol/Dexmedetomidine Versus Desflurane Effects on Post Hepatectomy Hepatocellular Injury
A Early Phase 1 study testing Propofol, dexmedetomidine and Desflurane in people with Hepatectomy, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study will compare the effects of propofol/dexmedetomidine versus desflurane for maintenance of general anesthesia on hepatocellular injury in patients undergoing partial hepatectomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatectomy
- What is being tested?
- Propofol, dexmedetomidine and Desflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to Nov 2023
- Phase
- Early Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients American Society of Anesthesiologists physical status (ASA) I to II.
- Patients Child Pugh classification A to B.
- Both sexes.
- Aged between 18 years and 70 years
- Scheduled for more than 1 segment hepatectomy.
Who cannot join
- Patients with Child Pugh classification C.
- Patients younger than18 years old or older than 70 years old
- Patients performed additional ablation therapies (cryosurgery or radiofrequency ablation).
- Prior liver resection for donation.
- Scheduled resection not requiring inflow occlusion (Pringle's maneuver).
- Hypersensitivity to any of the used drugs.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 11591
Ola Lashin, master, 00201026034100, ola.lashin@gmail.com
About this study
This study will compare the effects of propofol/dexmedetomidine versus desflurane for maintenance of general anesthesia on hepatocellular injury in patients undergoing partial hepatectomy.
Read the detailed description
Postoperative impairment of liver function is common after hepatectomy. It may be caused by surgical trauma, loss of hepatic mass, stress response, hepatic oxygen deprivation, infection and drug toxicity.
Anesthetic agents used in general anesthesia for liver surgery have a big effect on hepatic blood flow, oxygen delivery and liver function This study will compare the effects of propofol/dexmedetomidine versus desflurane for maintenance of general anesthesia on hepatocellular injury in patients undergoing partial hepatectomy.
- Conditions
- Hepatectomy
- Being tested
- Propofol, dexmedetomidine, Desflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol, dexmedetomidineDrug
Also called TIVA
Patients will receive maintenance of general anesthesia by TIVA using combination of propofol and dexmedetomidine.
DesfluraneDrug
Also called inhalational anesthesia
Patients will receive maintenance of general anesthesia by desflurane.
| Study group | Role | What they receive |
|---|---|---|
| propofol and dexmedetomidine | Experimental | Patients will receive maintenance of general anesthesia by TIVA using combination of propofol and dexmedetomidine Receives: Drug: Propofol, dexmedetomidine |
| desflurane | Experimental | Patients will receive maintenance of general anesthesia by desflurane. Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
aspartate aminotransferase (AST)
aspartate aminotransferase (AST)
Measured: 1 week
alanine aminotransferase (ALT)
alanine aminotransferase (ALT)
Measured: 1 week
bilirubin
bilirubin
Measured: 1 week
albumin
albumin
Measured: 1 week
prothrombin time
prothrombin time
Measured: 1 week
INR
INR
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Jun 2021
- Primary completion1 Nov 2021
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatectomyStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hany Alzahaby, Professor, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246371
- Sponsor's protocol ID
- Ain Shams anesthesia Dep
- Status last verified
- Jan 2023
- First submitted
- 21 Jan 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: open source
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol/Dexmedetomidine Versus Desflurane Effects on Post Hepatectomy Hepatocellular Injury
- ClinicalTrials.gov ID
- NCT05246371
- Acronym / sponsor ID
- Ain Shams anesthesia Dep
- Conditions
- Hepatectomy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- Nov 2023 (estimated)
- First posted
- 18 Feb 2022 (actual)
- 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.
This study will compare the effects of propofol/dexmedetomidine versus desflurane for maintenance of general anesthesia on hepatocellular injury in patients undergoing partial hepatectomy.
Detailed description
Postoperative impairment of liver function is common after hepatectomy. It may be caused by surgical trauma, loss of hepatic mass, stress response, hepatic oxygen deprivation, infection and drug toxicity.
Anesthetic agents used in general anesthesia for liver surgery have a big effect on hepatic blood flow, oxygen delivery and liver function This study will compare the effects of propofol/dexmedetomidine versus desflurane for maintenance of general anesthesia on hepatocellular injury in patients undergoing partial hepatectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol and dexmedetomidine | Experimental | Drug: Propofol, dexmedetomidinePatients will receive maintenance of general anesthesia by TIVA using combination of propofol and dexmedetomidine |
| desflurane | Experimental | Drug: DesfluranePatients will receive maintenance of general anesthesia by desflurane. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients American Society of Anesthesiologists physical status (ASA) I to II.
- Patients Child Pugh classification A to B.
- Both sexes.
- Aged between 18 years and 70 years
- Scheduled for more than 1 segment hepatectomy.
Key exclusion criteria (6 listed)
- Patients with Child Pugh classification C.
- Patients younger than18 years old or older than 70 years old
- Patients performed additional ablation therapies (cryosurgery or radiofrequency ablation).
- Prior liver resection for donation.
- Scheduled resection not requiring inflow occlusion (Pringle's maneuver).
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 |
|---|---|---|
| Propofol, dexmedetomidineAlso: TIVAPatients will receive maintenance of general anesthesia by TIVA using combination of propofol and dexmedetomidine. | Drug | propofol and dexmedetomidine |
| DesfluraneAlso: inhalational anesthesiaPatients will receive maintenance of general anesthesia by desflurane. | Drug | desflurane |
Primary outcome
aspartate aminotransferase (AST)
Time frame: 1 week
aspartate aminotransferase (AST)
alanine aminotransferase (ALT)
Time frame: 1 week
alanine aminotransferase (ALT)
bilirubin
Time frame: 1 week
bilirubin
albumin
Time frame: 1 week
albumin
prothrombin time
Time frame: 1 week
prothrombin time
INR
Time frame: 1 week
INR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: Yes. open source
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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.
Hany Alzahaby, Professor study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Propofol, dexmedetomidine and Desflurane in people with Hepatectomy, run by Ain Shams 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 5 inclusion and 6 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 18 Jan 2023. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact ola Lashin, Master (00201026034100, Ola.lashin@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aspartate aminotransferase (AST) (time frame: 1 week). The study lists 6 primary outcomes in all. 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 18 Jan 2023.