Nfuence of Vasoactive Medication on Spinal OxygenationPhase 4NIRS continuNCT03846765
Influence of Continuous Administration of Phenylephrine Versus Dobutamine on Spinal Oxygen Saturation, Measured With Near-infrared Spectroscopy (NIRS).
A Phase 4 study testing Phenylephrine and Dobutamine in people with Nfuence of Vasoactive Medication on Spinal Oxygenation, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
To assess the effect of hemodynamic supportive medication on spinal vasculature, patients scheduled for arterial dilation of the lower limb were chosen as our study population. The spinal cord perfusion is not compromised in these patients, however, most patients suffer from hypotension during this kind of surgery… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nfuence of Vasoactive Medication on Spinal Oxygenation
- What is being tested?
- Phenylephrine and Dobutamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Jul 2019to 10 Nov 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18y
- Patient is scheduled for dilation of arterial blood vessels of the lower limb
Who cannot join
- Age < 18y
- BMI > 30
- severe valvular disease
- previous aortic surgery
- paraplegia/ paraparesis
- kidney replacement therapy
Show all 11Show fewer
- pacemaker
- pregnancy
- lactating participants
- preoperative use of ACE inhibitors.
- No sinus rhythm on preoperative ECG or at induction of anesthesia (patients with a history of atrial fibrillation can be included if they have a sinus rhythm on their preoperative ECG)
Trial locations and contacts
1 site in 1 country.
About this study
To assess the effect of hemodynamic supportive medication on spinal vasculature, patients scheduled for arterial dilation of the lower limb were chosen as our study population. The spinal cord perfusion is not compromised in these patients, however, most patients suffer from hypotension during this kind of surgery, due to the non-invasive type of surgery and the vasodilating effects of the anesthetics. Therefore, continuous administration of vasoactive medication (phenylephrine or dobutamine) is often required in order to increase blood pressure.
The aim of our study is to evaluate the effect of a continuous administration of phenylephrine or dobutamine on the spinal oxygenation, assessed by NIRS.
Read the detailed description
All patients receive standard anesthesia care during the surgical procedure. Before induction of anesthesia, baseline MAP will be defined and 6 additional sensors (stickers) will be applied to the back of the patient at three levels: 1 at the upper thoracic level(T3-T4), 2 at the lower thoracic level (T9-T10) and 2 at the lumbar region (L1-L2) and 1 on the deltoid muscle of the upper arm. Two sensors are routinely applied to the forehead to measure cerebral oxygenation and a BIS sensor is applied to measure depth of anesthesia. In all patients a non-invasive cardiac output monitor (Clearsight; EdwardsTM LifeScience, Irvine, CA, USA) is routinely used. This monitor provides a continuous arterial pressure waveform in a non-invasive way and facilitates continuous evaluation of blood pressure. Hereby, efficient adaptation of the administration of vasopressors is feasible. Through an intravenous line, anesthetics will be administered. Vasopressor agents will be administered through a dedicated second intravenous line. After induction of anesthesia, an endotracheal tube is placed.
A vasopressor agent will be administered continuously after intubation in order to maintain blood pressure in a range from MAPbaseline -20% to normal (preoperative) values (MAPbaseline). If MAP decreases to a value lower than MAPbaseline -20%, a higher dose of vasopressor will be administered. If MAP increases to a value above MAPbaseline, the dosing rate will be decreased. According to the group to which the patient has been randomized, phenylephrine or dobutamine will be administered and the dose will be adjusted to MAP during a 30-minute study period.
The total drug amount for phenylephrine and dobutamine will not exceed 5 mg, resp. 30 mg.
The study will be completed after 30 minutes of continuous medicamentous hemodynamic support administration (i.e. 30 minutes after intubation) or if administration of phenylephrine or dobutamine exceeds 1 µg/kg/min or 10 µg/kg/min, respectively.
If the administration of the study medication does not achieve the desired result, management of the hemodynamics will be left to the discretion of the attending anesthesiologist and the patient will be excluded from further data analysis.
The endovascular surgical procedure can start without delay and the duration of surgery will not be prolonged because of the measurements and blood pressure management
- Being tested
- Phenylephrine, Dobutamine
- Keywords
- spinal oxygenation, NIRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
Phenylephrine will be administered continuously after intubation in order to maintain blood pressure in a range from MAPbaseline -20% to normal (preoperative) values (MAPbaseline). If MAP decreases to a value lower than MAPbaseline -20%, a higher dose of vasopressor will be administered. If MAP increases to a value above MAPbaseline, the dosing rate will be decreased.
Phenylephrine will be started at 0,2 μg/kg/min and adjusted according to the patient's hemodynamic status. The dose will be adjusted to MAP during a 30-minute study period.
DobutamineDrug
Dobutamine will be administered continuously after intubation in order to maintain blood pressure in a range from MAPbaseline -20% to normal (preoperative) values (MAPbaseline). If MAP decreases to a value lower than MAPbaseline -20%, a higher dose of vasopressor will be administered. If MAP increases to a value above MAPbaseline, the dosing rate will be decreased.
Dobutamine will be started at 2 μg/kg/min; and adjusted according to the patient's hemodynamic status .The dose will be adjusted to MAP during a 30-minute study period.
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine continuous infusion | Experimental | Not described Receives: Drug: Phenylephrine |
| Dobutamine continuous infusion | Experimental | Not described Receives: Drug: Dobutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal oxygen saturation measured by NIRS
Spinal oxygen saturation measured by NIRS
Measured: from intubation until 30 minutes after intubation
Secondary outcomes (2)
Cerebral oxygen saturation
Cerebral oxygen saturation measured by NIRS
Measured: from intubation until 30 minutes after intubation
Deltoid muscle oxygen saturation
Deltoid muscle oxygen saturation measured by NIRS
Measured: from intubation until 30 minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start4 Jul 2019
- Primary completion22 May 2021
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nfuence of Vasoactive Medication on Spinal OxygenationStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Vanpeteghem, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846765
- Sponsor's protocol ID
- 2018/1510
- Acronym
- NIRS continu
- Status last verified
- Dec 2022
- First submitted
- 15 Feb 2019
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Continuous Administration of Phenylephrine Versus Dobutamine on Spinal Oxygen Saturation, Measured With Near-infrared Spectroscopy (NIRS).
- ClinicalTrials.gov ID
- NCT03846765
- Acronym / sponsor ID
- NIRS continu / 2018/1510
- Keywords
- spinal oxygenation, NIRS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 22 May 2021 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 20 Feb 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.
To assess the effect of hemodynamic supportive medication on spinal vasculature, patients scheduled for arterial dilation of the lower limb were chosen as our study population. The spinal cord perfusion is not compromised in these patients, however, most patients suffer from hypotension during this kind of surgery, due to the non-invasive type of surgery and the vasodilating effects of the anesthetics. Therefore, continuous administration of vasoactive medication (phenylephrine or dobutamine) is often required in order to increase blood pressure.
The aim of our study is to evaluate the effect of a continuous administration of phenylephrine or dobutamine on the spinal oxygenation, assessed by NIRS.
Detailed description
All patients receive standard anesthesia care during the surgical procedure. Before induction of anesthesia, baseline MAP will be defined and 6 additional sensors (stickers) will be applied to the back of the patient at three levels: 1 at the upper thoracic level(T3-T4), 2 at the lower thoracic level (T9-T10) and 2 at the lumbar region (L1-L2) and 1 on the deltoid muscle of the upper arm. Two sensors are routinely applied to the forehead to measure cerebral oxygenation and a BIS sensor is applied to measure depth of anesthesia. In all patients a non-invasive cardiac output monitor (Clearsight; EdwardsTM LifeScience, Irvine, CA, USA) is routinely used. This monitor provides a continuous arterial pressure waveform in a non-invasive way and facilitates continuous evaluation of blood pressure. Hereby, efficient adaptation of the administration of vasopressors is feasible. Through an intravenous line, anesthetics will be administered. Vasopressor agents will be administered through a dedicated second intravenous line. After induction of anesthesia, an endotracheal tube is placed.
A vasopressor agent will be administered continuously after intubation in order to maintain blood pressure in a range from MAPbaseline -20% to normal (preoperative) values (MAPbaseline). If MAP decreases to a value lower than MAPbaseline -20%, a higher dose of vasopressor will be administered. If MAP increases to a value above MAPbaseline, the dosing rate will be decreased. According to the group to which the patient has been randomized, phenylephrine or dobutamine will be administered and the dose will be adjusted to MAP during a 30-minute study period.
The total drug amount for phenylephrine and dobutamine will not exceed 5 mg, resp. 30 mg.
The study will be completed after 30 minutes of continuous medicamentous hemodynamic support administration (i.e. 30 minutes after intubation) or if administration of phenylephrine or dobutamine exceeds 1 µg/kg/min or 10 µg/kg/min, respectively.
If the administration of the study medication does not achieve the desired result, management of the hemodynamics will be left to the discretion of the attending anesthesiologist and the patient will be excluded from further data analysis.
The endovascular surgical procedure can start without delay and the duration of surgery will not be prolonged because of the measurements and blood pressure management
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine continuous infusion | Experimental | Drug: Phenylephrine |
| Dobutamine continuous infusion | Experimental | Drug: Dobutamine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ≥ 18y
- Patient is scheduled for dilation of arterial blood vessels of the lower limb
Key exclusion criteria (11 listed)
- Age < 18y
- BMI > 30
- severe valvular disease
- previous aortic surgery
- paraplegia/ paraparesis
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 |
|---|---|---|
| PhenylephrinePhenylephrine will be administered continuously after intubation in order to maintain blood pressure in a range from MAPbaseline -20% to normal (preoperative) values (MAPbaseline). If MAP decreases to a value lower than MAPbaseline -20%, a higher dose of vasopressor will be administered. If MAP increases to a value above MAPbaseline, the dosing rate will be decreased. Phenylephrine will be started at 0,2 μg/kg/min and adjusted according to the patient's hemodynamic status. The dose will be adjusted to MAP during a 30-minute study period. | Drug | Phenylephrine continuous infusion |
| DobutamineDobutamine will be administered continuously after intubation in order to maintain blood pressure in a range from MAPbaseline -20% to normal (preoperative) values (MAPbaseline). If MAP decreases to a value lower than MAPbaseline -20%, a higher dose of vasopressor will be administered. If MAP increases to a value above MAPbaseline, the dosing rate will be decreased. Dobutamine will be started at 2 μg/kg/min; and adjusted according to the patient's hemodynamic status .The dose will be adjusted to MAP during a 30-minute study period. | Drug | Dobutamine continuous infusion |
Primary outcome
Spinal oxygen saturation measured by NIRS
Time frame: from intubation until 30 minutes after intubation
Spinal oxygen saturation measured by NIRS
2 secondary outcomes
Cerebral oxygen saturation
Time frame: from intubation until 30 minutes after intubation
Deltoid muscle oxygen saturation
Time frame: from intubation until 30 minutes after intubation
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 12 Dec 2022.
- Individual participant dataSharing planned: No
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.
Caroline Vanpeteghem, MD principal investigator
University Hospital, Ghent
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 Phenylephrine and Dobutamine in people with Nfuence of Vasoactive Medication on Spinal Oxygenation, run by University Hospital, Ghent at 1 site in Belgium.
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 2 inclusion and 11 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 12 Dec 2022. 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 Belgium. 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?
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?
Spinal oxygen saturation measured by NIRS (time frame: from intubation until 30 minutes after intubation). 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 12 Dec 2022.