Renal FailureEarly Phase 1NCT04171349
Articaine vs Dexmedetomidine Supplemented Articaine
A Early Phase 1 study testing Articaine and Dexmedetomidine in people with Renal Failure, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study to test efficacy of adding dexmedetomidine to articaine on sensory, motor and duration of analgesia during hemodialysis fistula creation under ultrasound guided supraclavicular block Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Failure
- What is being tested?
- Articaine and Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 1 Nov 2019
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult patient with chronic renal failure on hemodialysis scheduled for radiocephalic fistula creation
Who cannot join
- Allergy to local anesthetics.
- Infection at the site of needle insertion.
- Those having international normalized ratio more than 1.5.
- Coagulopathy.
- Neuromuscular, or severe hepatic or severe pulmonary disease.
- Those having epilepsy.
- Patients who refused to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Articaine and Dexmedetomidine - Supplemented Articaine for Arteriovenous Fistula Creation Under Ultrasound- Guided Supraclavicular Block
The aim of this study to test efficacy of adding dexmedetomidine to articaine on sensory, motor and duration of analgesia during hemodialysis fistula creation under ultrasound guided supraclavicular block
Read the detailed description
Adult fifty patient with chronic renal failure on hemodialysis, scheduled for arteriovenous fistula creation under ultrasound guided supraclavicular block. Patients were randomly allocated in two group. The articaine group (group A) received 40 ml articaine hydrochloride 2% and articaine-dexmedetomidine group (group AD) received 40 ml. Of articaine 2% mixed with dexmedetomidine (1micogram/kg)
- Conditions
- Renal Failure
- Being tested
- Articaine, Dexmedetomidine
- Keywords
- Hemodialysis
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArticaineDrug
Vial
DexmedetomidineDrug
Vial
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients received ultrasound guided supraclavicular block with 40 ml of Articaine hydrochloride 2% Receives: Drug: Articaine |
| Group AD | Experimental | Patients received ultrasound guided supraclavicular block with 40 ml articaine 2% mixed with dexmedetomidine (1 µg/kg). Receives: Drug: Articaine; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of sensory block
Sensory block time tested by pinprick test measured in minute
Measured: 24 hours
Duration of motor block
Motor block time tested by Bromage scale measured in minutes
Measured: 24 hours
Secondary outcomes (1)
Duration of analgesia
Measured by visual analog scale score 4
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 posted20 Nov 2019
- Study start1 Jun 2019
- Primary completion1 Oct 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, simon Halim Armanious, Ain Shams University
- Investigators
- Galal Mo Professor, Doctor, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171349
- Sponsor's protocol ID
- Articaine
- Status last verified
- Nov 2019
- First submitted
- 15 Nov 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participants data for all primary and secondary outcome measures will be available
Publications
Armanious SH, Abdelhameed GA. Articaine and Dexmedetomidine - Supplemented Articaine for Arteriovenous Fistula Creation under Ultrasound-guided Supraclavicular Block. Anesth Essays Res. 2020 Apr-Jun;14(2):248-252. doi: 10.4103/aer.AER_147_19. Epub 2020 Oct 12.
PubMed 33487824
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Articaine and Dexmedetomidine - Supplemented Articaine for Arteriovenous Fistula Creation Under Ultrasound- Guided Supraclavicular Block
- ClinicalTrials.gov ID
- NCT04171349
- Acronym / sponsor ID
- Articaine
- Conditions
- Renal Failure
- Keywords
- Hemodialysis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 20 Nov 2019 (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.
The aim of this study to test efficacy of adding dexmedetomidine to articaine on sensory, motor and duration of analgesia during hemodialysis fistula creation under ultrasound guided supraclavicular block
Detailed description
Adult fifty patient with chronic renal failure on hemodialysis, scheduled for arteriovenous fistula creation under ultrasound guided supraclavicular block. Patients were randomly allocated in two group. The articaine group (group A) received 40 ml articaine hydrochloride 2% and articaine-dexmedetomidine group (group AD) received 40 ml. Of articaine 2% mixed with dexmedetomidine (1micogram/kg)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: ArticainePatients received ultrasound guided supraclavicular block with 40 ml of Articaine hydrochloride 2% |
| Group AD | Experimental | Drug: Articaine, Drug: DexmedetomidinePatients received ultrasound guided supraclavicular block with 40 ml articaine 2% mixed with dexmedetomidine (1 µg/kg). |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patient with chronic renal failure on hemodialysis scheduled for radiocephalic fistula creation
Key exclusion criteria (7 listed)
- Allergy to local anesthetics.
- Infection at the site of needle insertion.
- Those having international normalized ratio more than 1.5.
- Coagulopathy.
- Neuromuscular, or severe hepatic or severe pulmonary 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 |
|---|---|---|
| ArticaineVial | Drug | Group A, Group AD |
| DexmedetomidineVial | Drug | Group AD |
Primary outcome
Duration of sensory block
Time frame: 24 hours
Sensory block time tested by pinprick test measured in minute
Duration of motor block
Time frame: 24 hours
Motor block time tested by Bromage scale measured in minutes
1 secondary outcome
Duration of analgesia
Time frame: 24 hours
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 20 Nov 2019.
- Derived from this study: PubMed 33487824Armanious SH, Abdelhameed GA. Articaine and Dexmedetomidine - Supplemented Articaine for Arteriovenous Fistula Creation under Ultrasound-guided Supraclavicular Block. Anesth Essays Res. 2020 Apr-Jun;14(2):248-252. doi: 10.4103/aer.AER_147_19. Epub 2020 Oct 12.
- Individual participant dataSharing planned: Yes. De-identified individual participants data for all primary and secondary outcome measures will be available
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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.
Galal Mo Professor, Doctor study director
Professor
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 Articaine and Dexmedetomidine in people with Renal Failure, 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 1 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: finished, as of the sponsor's last update on 20 Nov 2019. 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?
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?
Duration of sensory block (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04171349, which also lists 1 linked publication.
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 20 Nov 2019.