AnesthesiaPhase 4NCT03393988
Techniques for Perioperative Analgesia for Live Liver Donors; A Pilot Study
A Phase 4 study testing Fentanyl infusion, Ultrasound guided TAP block and Dexmedetomidine in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study,will evaluate the efficacy of ultrasound (US)-guided subcostal oblique TAP block together with IV infusion of Dexmedetomidine and fentanyl as a type of multimodal analgesic regimen in comparison with IV fentanyl based analgesia only in live liver donors. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Fentanyl infusion, Ultrasound guided TAP block and Dexmedetomidine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Dec 2017to Feb 2019
- Phase
- Phase 4
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesia (ASA) physical status I or II
- Scheduled as live liver donors
- J-shaped incision in the supraumblical region
Who cannot join
- Patients with a history of psychiatric/neurological illness,
- Hypertensive patients,
- Morbidly obese patients,
- Pregnant and nursing women,
- Patients with known allergic reaction to any of the study medications,
- Patients on recent use of sedatives or analgesics,
- Patients with significant laboratory abnormalities
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Hospitals of Faculty of Medicine , Ain Shams University
Cairo, 11591
About this study
Official title: A Pilot Study for a Prospective, Randomized Controlled Trial of Techniques for Perioperative Analgesia for Live Liver Donors
This study,will evaluate the efficacy of ultrasound (US)-guided subcostal oblique TAP block together with IV infusion of Dexmedetomidine and fentanyl as a type of multimodal analgesic regimen in comparison with IV fentanyl based analgesia only in live liver donors.
- Conditions
- Anesthesia
- Being tested
- Fentanyl infusion, Ultrasound guided TAP block, Dexmedetomidine
- Keywords
- Transversus abdominis plane block,, Dexmedetomidine, Fentanyl, Live liver donor, Liver transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl infusionDrug
Also called Opioid
After induction of general anesthesia; Fentanyl infusion (0.5 µg/kg/hr) will be started (which will be afterwards adjusted intraoperatively according to the hemodynamics and Bispectral Index (BIS) reading).
Ultrasound guided TAP blockProcedure or surgery
Also called Regional anesthesia
After induction of general anesthesia; Patients will receive ultrasound guided subcostal oblique TAP block with 0.25 % bupivacaine 40 ml on each side resulting in a total volume of 80 ml, subcostal TAP block was given twice, at the beginning and at the end of the surgery.
DexmedetomidineDrug
Also called alpha 2 sympathomimetic
Dexmedetomidine (200 µg in 2 ml diluted in 48 ml of saline) will be started in a dose of 1 μg/kg over 10 min then maintenance dose as continuous infusion between 0.2 and 0.8 μg/ kg/h through infusion pump (which will be adjusted according to the hemodynamics and BIS reading)
| Study group | Role | What they receive |
|---|---|---|
| Group F | Active comparator | Fentanyl infusion (0.5 µg/kg/hr) Receives: Drug: Fentanyl infusion |
| Group (TAP-Dex) | Active comparator | Ultrasound guided TAP block and Dexmedetomidine
* Ultrasound guided subcostal oblique TAP block with 0.25 % bupivacaine
* Dexmedetomidine infusion(200 µg in 2 ml diluted in 48 ml of saline)
* Fentanyl infusion (0.5 µg/kg/hr). Receives: Drug: Fentanyl infusion; Procedure: Ultrasound guided TAP block; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total fentanyl consumption
Total Intravenous fentanyl consumption during the operation
Measured: Intraoperative
Secondary outcomes (3)
Average sevoflurane concentration
The average sevoflurane concentration (the average concentration (%) for the case will be determined from the vaporizer setting recorded in the anesthetic record per 5-minute interval)
Measured: Intraoperative
The severity of postoperative nausea and vomiting (PONV)
Will be recorded and classified as "no PONV, mild PONV, moderate PONV and severe PONV"
Measured: First 24 hours postoperatively
Ramsay sedation score (RSS)
Will be used for assessment of sedation immediately after extubation, after 2 hours of ICU admission, after 12 hours then after 24 hours .
Measured: First 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start7 Dec 2017
- Primary completionDec 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Samir Abd-ElWahab Bondok, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393988
- Sponsor's protocol ID
- FMASU R45/2017
- Status last verified
- Jan 2018
- First submitted
- 23 Dec 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for a Prospective, Randomized Controlled Trial of Techniques for Perioperative Analgesia for Live Liver Donors
- ClinicalTrials.gov ID
- NCT03393988
- Acronym / sponsor ID
- FMASU R45/2017
- Conditions
- Anesthesia
- Keywords
- Transversus abdominis plane block,, Dexmedetomidine, Fentanyl, Live liver donor, Liver transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 9 Jan 2018 (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 evaluate the efficacy of ultrasound (US)-guided subcostal oblique TAP block together with IV infusion of Dexmedetomidine and fentanyl as a type of multimodal analgesic regimen in comparison with IV fentanyl based analgesia only in live liver donors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group F | Active comparator | Drug: Fentanyl infusionFentanyl infusion (0.5 µg/kg/hr) |
| Group (TAP-Dex) | Active comparator | Drug: Fentanyl infusion, Procedure: Ultrasound guided TAP block, Drug: DexmedetomidineUltrasound guided TAP block and Dexmedetomidine * Ultrasound guided subcostal oblique TAP block with 0.25 % bupivacaine * Dexmedetomidine infusion(200 µg in 2 ml diluted in 48 ml of saline) * Fentanyl infusion (0.5 µg/kg/hr). |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesia (ASA) physical status I or II
- Scheduled as live liver donors
- J-shaped incision in the supraumblical region
Key exclusion criteria (7 listed)
- Patients with a history of psychiatric/neurological illness,
- Hypertensive patients,
- Morbidly obese patients,
- Pregnant and nursing women,
- Patients with known allergic reaction to any of the study medications,
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 |
|---|---|---|
| Fentanyl infusionAlso: OpioidAfter induction of general anesthesia; Fentanyl infusion (0.5 µg/kg/hr) will be started (which will be afterwards adjusted intraoperatively according to the hemodynamics and Bispectral Index (BIS) reading). | Drug | Group (TAP-Dex), Group F |
| Ultrasound guided TAP blockAlso: Regional anesthesiaAfter induction of general anesthesia; Patients will receive ultrasound guided subcostal oblique TAP block with 0.25 % bupivacaine 40 ml on each side resulting in a total volume of 80 ml, subcostal TAP block was given twice, at the beginning and at the end of the surgery. | Procedure or surgery | Group (TAP-Dex) |
| DexmedetomidineAlso: alpha 2 sympathomimeticDexmedetomidine (200 µg in 2 ml diluted in 48 ml of saline) will be started in a dose of 1 μg/kg over 10 min then maintenance dose as continuous infusion between 0.2 and 0.8 μg/ kg/h through infusion pump (which will be adjusted according to the hemodynamics and BIS reading) | Drug | Group (TAP-Dex) |
Primary outcome
Total fentanyl consumption
Time frame: Intraoperative
Total Intravenous fentanyl consumption during the operation
3 secondary outcomes
Average sevoflurane concentration
Time frame: Intraoperative
The severity of postoperative nausea and vomiting (PONV)
Time frame: First 24 hours postoperatively
Ramsay sedation score (RSS)
Time frame: First 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
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 Phase 4 study testing Fentanyl infusion, Ultrasound guided TAP block and Dexmedetomidine in people with Anesthesia, 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 3 inclusion and 7 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 Jan 2018. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
Total fentanyl consumption (time frame: Intraoperative). 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 Jan 2018.