End Stage Renal DiseasePhase 1NCT03311581
The Feasibility of Propofol TCI in Hemodialysis Patients Undergoing Arteriovenous Shunt Surgery
A Phase 1 study testing Propofol and Sevoflurane in people with End Stage Renal Disease and Hemodialysis Complication, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Written informed consent must be obtained before any study specific procedures are undertaken. Informed consent will be obtained during pre-operative assessment. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- End Stage Renal Disease, Hemodialysis Complication
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Sep 2017to 4 Jun 2021
- Phase
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uremic adult(over20-year-old)patients under going arteriovenous (AV) shunt surgery
Who cannot join
- one of below systemic diseases; chronic pulmonary, cardiac diseases(such as COPD, asthma, acute myoischemia), hepatic co-mobility(such as liver cirrhosis), morbid obesity, alcoholism, allergy to propofol and inhaled anesthetics, the women who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Written informed consent must be obtained before any study specific procedures are undertaken. Informed consent will be obtained during pre-operative assessment.
Read the detailed description
The investigators will recruit 80 patients undergoing AV shunt surgery. All patients will receive general anesthesia and brachial plexus block. Patients will be randomly allocated into two groups. Study and control group received propofol target-controlled infusion (TCI) and inhaled anesthetics as anesthesia maintenance, respectively. Main outcomes will be assessed by perioperative blood pressure, heart rate, respiratory rate, end-tidal CO2, analgesics dosage, pain intensity and perioperative adverse events.
- Conditions
- End Stage Renal Disease, Hemodialysis Complication
- Being tested
- Propofol, Sevoflurane
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Propofol works by increasing GABA-mediated inhibitory tone in the CNS. Propofol decreases the rate of dissociation of the GABA from the receptor, thereby increasing the duration of the GABA-activated opening of the chloride channel with resulting hyperpolarization of cell membranes.
SevofluraneDevice
sevoflurane inhalation 2~4%
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Experimental | propofol TCI plus brachial plexus block with ropivacaine 0.5% 30 to 40 ml Receives: Drug: Propofol |
| Sevoflurane group | Active comparator | sevoflurane 2~4 % plus brachial plexus block with ropivacaine 0.5% 30 to 40 ml Receives: Device: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Systolic blood pressure, diastolic blood pressure
Measured: The blood pressure change between baseline, post-induction 3mins, operation start, post-operation 10 mins,post-operation 30 mins,post-operation 1 hour,post-operation 2 hours, end of surgery, recovery room, up to 4 hours
Secondary outcomes (2)
analgesics dosage
post-operation analgesics dosage
Measured: The amount of analgesics dosage use at recovery room,an average of 4 hours
Change in pain intensity
Visual Analog Score for pain
Measured: The pain intensity change at recovery room, post-operation day 1, post-operation day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start11 Sep 2017
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311581
- Sponsor's protocol ID
- KMUHIRB-F(II)-20170080
- Status last verified
- May 2020
- First submitted
- 17 Sep 2017
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Propofol TCI in Hemodialysis Patients Undergoing Arteriovenous Shunt Surgery
- ClinicalTrials.gov ID
- NCT03311581
- Acronym / sponsor ID
- KMUHIRB-F(II)-20170080
- Conditions
- End Stage Renal Disease, Hemodialysis Complication
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 17 Oct 2017 (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.
Written informed consent must be obtained before any study specific procedures are undertaken. Informed consent will be obtained during pre-operative assessment.
Detailed description
The investigators will recruit 80 patients undergoing AV shunt surgery. All patients will receive general anesthesia and brachial plexus block. Patients will be randomly allocated into two groups. Study and control group received propofol target-controlled infusion (TCI) and inhaled anesthetics as anesthesia maintenance, respectively. Main outcomes will be assessed by perioperative blood pressure, heart rate, respiratory rate, end-tidal CO2, analgesics dosage, pain intensity and perioperative adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol group | Experimental | Drug: Propofolpropofol TCI plus brachial plexus block with ropivacaine 0.5% 30 to 40 ml |
| Sevoflurane group | Active comparator | Device: Sevofluranesevoflurane 2~4 % plus brachial plexus block with ropivacaine 0.5% 30 to 40 ml |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Uremic adult(over20-year-old)patients under going arteriovenous (AV) shunt surgery
Key exclusion criteria (1 listed)
- one of below systemic diseases; chronic pulmonary, cardiac diseases(such as COPD, asthma, acute myoischemia), hepatic co-mobility(such as liver cirrhosis), morbid obesity, alcoholism, allergy to propofol and inhaled anesthetics, the women who are pregnant or breastfeeding
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 |
|---|---|---|
| PropofolPropofol works by increasing GABA-mediated inhibitory tone in the CNS. Propofol decreases the rate of dissociation of the GABA from the receptor, thereby increasing the duration of the GABA-activated opening of the chloride channel with resulting hyperpolarization of cell membranes. | Drug | Propofol group |
| Sevofluranesevoflurane inhalation 2~4% | Device | Sevoflurane group |
Primary outcome
Change in blood pressure
Time frame: The blood pressure change between baseline, post-induction 3mins, operation start, post-operation 10 mins,post-operation 30 mins,post-operation 1 hour,post-operation 2 hours, end of surgery, recovery room, up to 4 hours
Systolic blood pressure, diastolic blood pressure
2 secondary outcomes
analgesics dosage
Time frame: The amount of analgesics dosage use at recovery room,an average of 4 hours
Change in pain intensity
Time frame: The pain intensity change at recovery room, post-operation day 1, post-operation day 2
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 5 Sep 2021.
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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 1 study testing Propofol and Sevoflurane in people with End Stage Renal Disease and Hemodialysis Complication, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 5 Sep 2021. 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 Taiwan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in blood pressure (time frame: The blood pressure change between baseline, post-induction 3mins, operation start, post-operation 10 mins,post-operation 30 mins,post-operation 1 hour,post-operation 2 hours, end of surgery, recovery room, up to 4 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 5 Sep 2021.