Hemodynamic InstabilityNCT03195166
Hemodynamic Effects of Continuous Spinal Anesthesia in Patient Aged Over 65 Years
A study testing FloTrac sensor/Vigileo in people with Hemodynamic Instability, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Compared to single-dose spinal anesthesia, continuous spinal anesthesia using small titrated doses of local anesthetic, was safe, efficient and provided better hemodynamic profile in elderly patients. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- FloTrac sensor/Vigileo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTunisia
- Study dates
- 3 Nov 2017to 31 Dec 2020
- Phase
- Interventional
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adult patients, aged more than 65 years
- scheduled for elective total knee arthroplasty
- under regional anesthesia
Who cannot join
- contraindication to regional anesthesia
- or the patients who refused to give consent,
- patients with anemia (hemoglobin < 13 g/dl for male and hemoglobin < 12 g/dl for female),
- cardiac arrhythmias,
- NYHA score > 2,
- ASA > 2
Show all 10Show fewer
- Cardiac ejection fraction < 50 %,
- valvulopathy,
- pulmonary artery hypertension
- and relaxation abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Effects of Continuous Spinal Anesthesia in Patient Aged Over 65 Years Undergoing Total Knee Arthroplasty
Compared to single-dose spinal anesthesia, continuous spinal anesthesia using small titrated doses of local anesthetic, was safe, efficient and provided better hemodynamic profile in elderly patients.
The aim of this study was to investigate the hemodynamic effects of continuous spinal anesthesia in elderly patients undergoing knee arthroplasty.
Read more
Investigators use the FloTrac sensor/Vigileo haemodynamic monitoring system to assess modification blood pressure, stroke volume and cardiac output during anesthesia and specialy after every bolus of spinal anesthesia, after inflating the tourniquet and after putting it off.
they recorded number of hypotension episodes, ephedrine bolus and consumption until 2 hours after the end of surgery.
Read the detailed description
The aim of this study was to investigate the hemodynamic effects of continuous spinal anesthesia (CSA) in elderly patients undergoing knee arthroplasty.
Inclusion criteria:
Adult patients, aged more than 65 years scheduled for elective total knee arthroplasty under regional anesthesia.
Study Design :
Patients had a transthoracic echocardiography one to three months before the surgical procedure, performed by a cardiologist.
An oral intake of 250 ml of water was taken 2 hours before surgery. In the operating room, patients received monitoring with electrocardiogram, pulse oximetry and had their blood pressure measured and recorded via an indwelling radial arterial catheter putting under local anesthesia.
This catheter was connected to the FloTrac sensor/Vigileo haemodynamic monitoring systeme to track continuously stroke volume and cardiac output.
All patients were given nasal oxygen during all the procedure to keep oxygen saturation > 95 %. Fluid therapy was limited to 4 ml/kg/h until tourniquet release.
Subarachnoid puncture was performed with a 19-Gauge Tuohy needle at the L3-S1 interspace using a midline approach. Three cm of a 22-Gauge catheter was introduced through the needle. An initial dose of 2,5 mg isobaric 0,5% bupivacaine was injected through the catheter. Additional 2,5 mg isobaric 0,5% bupivacaine doses were injected every 10 minutes until sensory blockade reached T10.
Ephedrine 6 to 9 mg was given if systolic arterial pressure < 90 mmHg or < 100 mmHg with clinical signs of poor tolerance (dizziness, anxiety, dyspnea, vomiting).
Sample size We included 20 patients in this observational study.
- Conditions
- Hemodynamic Instability
- Being tested
- FloTrac sensor/Vigileo
- Keywords
- elderly spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FloTrac sensor/VigileoDiagnostic test
blood pressure (systolic, diastolic and mean), stroke volume cardiac output ephedrine consumption after bupivacaine continuous spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| hemodynamic profile | Experimental | FloTrac sensor/Vigileo Receives: Diagnostic Test: FloTrac sensor/Vigileo |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic profile during continuous spinal anesthesia in elderly
cardiac output , L/min
Measured: Day 0
Secondary outcomes (3)
blood pressure variation
systolic blood pressure, diastolic blood pressure, mean blood pressure, mmHg
Measured: Day 0
ephedrine use
ephedrine consumption , mg
Measured: Day 0
stoke volume modification
stroke volume, L
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start3 Nov 2017
- Primary completion30 Jun 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The aim of this study was to investigate the hemodynamic effects of continuous spinal anesthesia in elderly patients. An oral intake of 250 ml of water was taken 2 hours before surgery. Radial arterial catheter was putted under local anesthesia and connected to the FloTrac sensor/Vigileo haemodynamic monitoring system. Fluid therapy was limited to 4 ml/kg/h until tourniquet release. Subarachnoid puncture was performed at the L3-S1 interspace. An initial dose of 2,5 mg isobaric 0,5% bupivacaine was injected. Additional 2,5 mg isobaric 0,5% bupivacaine doses were injected every 10 minutes until sensory blockade reached T10. Ephedrine 6 to 9 mg was given if systolic arterial pressure \< 90 mmHg. Investigators measured blood pressure (systolic, diastolic and mean), stroke volume and cardiac output every 5 minutes from beginning of the operation and until 2 hours after the end. Number of hypotension episodes and ephedrine consumption were noted.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olfa kaabachi, MD, University Tunis El Manar
- Investigators
- KAABACHI OLFA, PROF, Study chair, KASSAB ORTHOPEDIC INSTITUTE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195166
- Sponsor's protocol ID
- 101/2017
- Status last verified
- Feb 2024
- First submitted
- 4 Jun 2017
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Continuous Spinal Anesthesia in Patient Aged Over 65 Years Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03195166
- Acronym / sponsor ID
- 101/2017
- Conditions
- Hemodynamic Instability
- Keywords
- elderly spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 22 Jun 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.
Compared to single-dose spinal anesthesia, continuous spinal anesthesia using small titrated doses of local anesthetic, was safe, efficient and provided better hemodynamic profile in elderly patients.
The aim of this study was to investigate the hemodynamic effects of continuous spinal anesthesia in elderly patients undergoing knee arthroplasty.
Investigators use the FloTrac sensor/Vigileo haemodynamic monitoring system to assess modification blood pressure, stroke volume and cardiac output during anesthesia and specialy after every bolus of spinal anesthesia, after inflating the tourniquet and after putting it off.
they recorded number of hypotension episodes, ephedrine bolus and consumption until 2 hours after the end of surgery.
Detailed description
The aim of this study was to investigate the hemodynamic effects of continuous spinal anesthesia (CSA) in elderly patients undergoing knee arthroplasty.
Inclusion criteria:
Adult patients, aged more than 65 years scheduled for elective total knee arthroplasty under regional anesthesia.
Study Design :
Patients had a transthoracic echocardiography one to three months before the surgical procedure, performed by a cardiologist.
An oral intake of 250 ml of water was taken 2 hours before surgery. In the operating room, patients received monitoring with electrocardiogram, pulse oximetry and had their blood pressure measured and recorded via an indwelling radial arterial catheter putting under local anesthesia.
This catheter was connected to the FloTrac sensor/Vigileo haemodynamic monitoring systeme to track continuously stroke volume and cardiac output.
All patients were given nasal oxygen during all the procedure to keep oxygen saturation > 95 %. Fluid therapy was limited to 4 ml/kg/h until tourniquet release.
Subarachnoid puncture was performed with a 19-Gauge Tuohy needle at the L3-S1 interspace using a midline approach. Three cm of a 22-Gauge catheter was introduced through the needle. An initial dose of 2,5 mg isobaric 0,5% bupivacaine was injected through the catheter. Additional 2,5 mg isobaric 0,5% bupivacaine doses were injected every 10 minutes until sensory blockade reached T10.
Ephedrine 6 to 9 mg was given if systolic arterial pressure < 90 mmHg or < 100 mmHg with clinical signs of poor tolerance (dizziness, anxiety, dyspnea, vomiting).
Sample size We included 20 patients in this observational study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The aim of this study was to investigate the hemodynamic effects of continuous spinal anesthesia in elderly patients. An oral intake of 250 ml of water was taken 2 hours before surgery. Radial arterial catheter was putted under local anesthesia and connected to the FloTrac sensor/Vigileo haemodynamic monitoring system. Fluid therapy was limited to 4 ml/kg/h until tourniquet release. Subarachnoid puncture was performed at the L3-S1 interspace. An initial dose of 2,5 mg isobaric 0,5% bupivacaine was injected. Additional 2,5 mg isobaric 0,5% bupivacaine doses were injected every 10 minutes until sensory blockade reached T10. Ephedrine 6 to 9 mg was given if systolic arterial pressure < 90 mmHg. Investigators measured blood pressure (systolic, diastolic and mean), stroke volume and cardiac output every 5 minutes from beginning of the operation and until 2 hours after the end. Number of hypotension episodes and ephedrine consumption were noted.
| Arm | Type | Receives |
|---|---|---|
| hemodynamic profile | Experimental | Diagnostic Test: FloTrac sensor/VigileoFloTrac sensor/Vigileo |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Adult patients, aged more than 65 years
- scheduled for elective total knee arthroplasty
- under regional anesthesia
Key exclusion criteria (10 listed)
- contraindication to regional anesthesia
- or the patients who refused to give consent,
- patients with anemia (hemoglobin < 13 g/dl for male and hemoglobin < 12 g/dl for female),
- cardiac arrhythmias,
- NYHA score > 2,
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 |
|---|---|---|
| FloTrac sensor/Vigileoblood pressure (systolic, diastolic and mean), stroke volume cardiac output ephedrine consumption after bupivacaine continuous spinal anesthesia | Diagnostic test | hemodynamic profile |
Primary outcome
hemodynamic profile during continuous spinal anesthesia in elderly
Time frame: Day 0
cardiac output , L/min
3 secondary outcomes
blood pressure variation
Time frame: Day 0
ephedrine use
Time frame: Day 0
stoke volume modification
Time frame: Day 0
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 13 Feb 2024.
- Individual participant dataSharing planned: No
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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.
KAABACHI OLFA, PROF study chair
KASSAB ORTHOPEDIC INSTITUTE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FloTrac sensor/Vigileo in people with Hemodynamic Instability, run by University Tunis El Manar at 1 site in Tunisia.
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 10 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 13 Feb 2024. 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 Tunisia. 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.
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?
hemodynamic profile during continuous spinal anesthesia in elderly (time frame: Day 0). 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 13 Feb 2024.