Spinal Stenosis, Lumbosacral RegionTIVANCT06558695
Stability Comparison of TIVA and Sevoflurane in Prone Spinal Surgery(TIVA:Total Intravenous Anesthesia)
A study testing Sevoflurane and TIVA in people with Spinal Stenosis, Lumbosacral Region, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Key Points: 1. Objective: o To compare the effects of Total Intravenous Anesthesia (TIVA) and sevoflurane anesthesia on respiratory mechanics, hemodynamic parameters, and neuromonitoring during prone position spinal surgeries. 2. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Stenosis, Lumbosacral Region
- What is being tested?
- Sevoflurane and TIVA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 30 Jun 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study included male and female patients aged 18 to 65 years who were scheduled for lumbar spine surgery under general anesthesia. Patients were categorized based on the American Society of Anesthesiologists (ASA) physical status levels I, II, and III.
Who cannot join
- Diagnosis of asthma or chronic obstructive pulmonary disease (COPD)
- Major cardiac conditions, such as recent myocardial infarction or a left ventricular ejection fraction (EF) less than 55%
- Atrioventricular blocks of second and third degrees
- Allergies to any drugs
- Severe neurological disorders
- History of sedative or opioid use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of TIVA and Sevoflurane: Affirming Hemodynamic, Respiratory, and Neuromonitoring Stability in Prone Position Spinal Surgeries
Key Points:
- Objective:
Read more
- To compare the effects of Total Intravenous Anesthesia (TIVA) and sevoflurane anesthesia on respiratory mechanics, hemodynamic parameters, and neuromonitoring during prone position spinal surgeries.
- Methodology:
- A randomized controlled trial involving 52 patients scheduled for lumbar spine surgery, randomly assigned to either TIVA or sevoflurane groups.
- Respiratory and hemodynamic parameters were measured at various time points.
- Results:
- No significant differences were found between the TIVA and sevoflurane groups in terms of respiratory mechanics or hemodynamic stability.
- Both anesthesia techniques maintained stable intraoperative conditions.
- Clinical Implications:
- Anesthesiologists can flexibly choose between TIVA and sevoflurane based on patient-specific factors and surgical requirements.
- TIVA may be preferred in surgeries with high neurological risk due to its compatibility with neuromonitoring.
- Future Research:
- Studies with broader patient populations and long-term outcomes are needed to further refine anesthesia management strategies.
- Research on the environmental impact and cost-effectiveness of anesthesia techniques is also important.
Read the detailed description
This study aims to evaluate the impact of total intravenous anesthesia (TIVA) versus sevoflurane anesthesia on respiratory mechanics and hemodynamic parameters during spinal surgery performed in the prone position. Anesthesia management for spinal surgeries in the prone position is particularly challenging due to significant physiological changes. Identifying the effects of different anesthesia techniques is essential to enhance patient outcomes and ensure intraoperative stability. This randomized controlled trial involved 52 patients scheduled for lumbar spine surgery under general anesthesia. Participants were randomly allocated to either the TIVA group (n=26) or the sevoflurane group (n=26). Measurements of respiratory mechanics, including peak airway pressure (Ppeak), mean airway pressure (Pmean), positive end-expiratory pressure (PEEP), end-tidal CO2 (ETCO2), tidal volume (VT), respiratory rate (RR), and minute ventilation (MV), were taken at various intervals. Hemodynamic parameters such as systolic and diastolic blood pressures and heart rate were continuously monitored.
- Conditions
- Spinal Stenosis, Lumbosacral Region
- Being tested
- Sevoflurane, TIVA
- Keywords
- Total intravenous anesthesia, Sevoflurane, Respiratory mechanics,, Hemodynamic parameters, Spinal surgery, Prone position
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Sevoflurane was managed for maintenance of the general anestesia during spinal surgeries
TIVADrug
Also called Total Intra Venous Anesthesia
TIVA was managed for maintenance of the general anesthesia during spinal surgeries
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane Group | Active comparator | In the Sevoflurane group, general anesthesia was maintained with sevoflurane at 0.8-1.0 minimum alveolar concentration (MAC). Receives: Drug: Sevoflurane |
| TIVA group | Active comparator | In the TIVA (Total Intra Venous Anesthesia) group, a combination of propofol (50-150 μg/kg/min) and remifentanil (0.02-0.2 μg/kg/min) was used for general anesthesia instead of inhalational agents. Receives: Drug: TIVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
PEEP
positive end-expiratory pressure
Measured: 5, 15, and 30 minutes after positioning in the prone position
ETCO2
end-tidal carbon dioxide
Measured: 5, 15, and 30 minutes after positioning in the prone position
VT
tidal volume
Measured: 5, 15, and 30 minutes after positioning in the prone position
Ppeak
peak airway pressure
Measured: 5, 15, and 30 minutes after positioning in the prone position
Pmean
mean airway pressure
Measured: 5, 15, and 30 minutes after positioning in the prone position
RR
Respiratory Rate
Measured: 5, 15, and 30 minutes after positioning in the prone position
MV
Minute volume
Measured: 5, 15, and 30 minutes after positioning in the prone position
Cdyn
Dynamic. compliance
Measured: in the supine position after intubation and in the prone position at the 30th minute
PaO2/FiO2
Partial Oxygen pressure/traction of inspired oxygen
Measured: in the prone position at the 30th minute
Vd/Vt
dead space/tidal volume
Measured: in the prone position at the 30th minute
Secondary outcomes (3)
HR
Heart Rate
Measured: 5, 15, and 30 minutes after positioning in the prone position
SBP
Systolic Blood Pressure
Measured: 5, 15, and 30 minutes after positioning in the prone position
DBP
Diastolic BloodPressure
Measured: 5, 15, and 30 minutes after positioning in the prone position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 May 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Stenosis, Lumbosacral RegionStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized controlled trial involved 52 patients scheduled for lumbar spine surgery under general anesthesia. Participants were randomly allocated to either the TIVA group (n=26) or the sevoflurane group (n=26). Measurements of respiratory mechanics, including peak airway pressure (Ppeak), mean airway pressure (Pmean), positive end-expiratory pressure (PEEP), end-tidal CO2 (ETCO2), tidal volume (VT), respiratory rate (RR), and minute ventilation (MV), were taken at various intervals. Hemodynamic parameters such as systolic and diastolic blood pressures and heart rate were continuously monitored.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YÜCEL YÜCE, Saglik Bilimleri Universitesi
- Investigators
- Yücel Yüce, MD,Assoc Prf, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558695
- Sponsor's protocol ID
- SaglikBilimleriU-KLKSH-Anes-01
- Acronym
- TIVA
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 19 Aug 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 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of TIVA and Sevoflurane: Affirming Hemodynamic, Respiratory, and Neuromonitoring Stability in Prone Position Spinal Surgeries
- ClinicalTrials.gov ID
- NCT06558695
- Acronym / sponsor ID
- TIVA / SaglikBilimleriU-KLKSH-Anes-01
- Conditions
- Spinal Stenosis, Lumbosacral Region
- Keywords
- Total intravenous anesthesia, Sevoflurane, Respiratory mechanics,, Hemodynamic parameters, Spinal surgery, Prone position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 Aug 2024 (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.
Key Points:
- Objective:
- To compare the effects of Total Intravenous Anesthesia (TIVA) and sevoflurane anesthesia on respiratory mechanics, hemodynamic parameters, and neuromonitoring during prone position spinal surgeries.
- Methodology:
- A randomized controlled trial involving 52 patients scheduled for lumbar spine surgery, randomly assigned to either TIVA or sevoflurane groups.
- Respiratory and hemodynamic parameters were measured at various time points.
- Results:
- No significant differences were found between the TIVA and sevoflurane groups in terms of respiratory mechanics or hemodynamic stability.
- Both anesthesia techniques maintained stable intraoperative conditions.
- Clinical Implications:
- Anesthesiologists can flexibly choose between TIVA and sevoflurane based on patient-specific factors and surgical requirements.
- TIVA may be preferred in surgeries with high neurological risk due to its compatibility with neuromonitoring.
- Future Research:
- Studies with broader patient populations and long-term outcomes are needed to further refine anesthesia management strategies.
- Research on the environmental impact and cost-effectiveness of anesthesia techniques is also important.
Detailed description
This study aims to evaluate the impact of total intravenous anesthesia (TIVA) versus sevoflurane anesthesia on respiratory mechanics and hemodynamic parameters during spinal surgery performed in the prone position. Anesthesia management for spinal surgeries in the prone position is particularly challenging due to significant physiological changes. Identifying the effects of different anesthesia techniques is essential to enhance patient outcomes and ensure intraoperative stability. This randomized controlled trial involved 52 patients scheduled for lumbar spine surgery under general anesthesia. Participants were randomly allocated to either the TIVA group (n=26) or the sevoflurane group (n=26). Measurements of respiratory mechanics, including peak airway pressure (Ppeak), mean airway pressure (Pmean), positive end-expiratory pressure (PEEP), end-tidal CO2 (ETCO2), tidal volume (VT), respiratory rate (RR), and minute ventilation (MV), were taken at various intervals. Hemodynamic parameters such as systolic and diastolic blood pressures and heart rate were continuously monitored.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized controlled trial involved 52 patients scheduled for lumbar spine surgery under general anesthesia. Participants were randomly allocated to either the TIVA group (n=26) or the sevoflurane group (n=26). Measurements of respiratory mechanics, including peak airway pressure (Ppeak), mean airway pressure (Pmean), positive end-expiratory pressure (PEEP), end-tidal CO2 (ETCO2), tidal volume (VT), respiratory rate (RR), and minute ventilation (MV), were taken at various intervals. Hemodynamic parameters such as systolic and diastolic blood pressures and heart rate were continuously monitored.
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane Group | Active comparator | Drug: SevofluraneIn the Sevoflurane group, general anesthesia was maintained with sevoflurane at 0.8-1.0 minimum alveolar concentration (MAC). |
| TIVA group | Active comparator | Drug: TIVAIn the TIVA (Total Intra Venous Anesthesia) group, a combination of propofol (50-150 μg/kg/min) and remifentanil (0.02-0.2 μg/kg/min) was used for general anesthesia instead of inhalational agents. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study included male and female patients aged 18 to 65 years who were scheduled for lumbar spine surgery under general anesthesia. Patients were categorized based on the American Society of Anesthesiologists (ASA) physical status levels I, II, and III.
Key exclusion criteria (6 listed)
- Diagnosis of asthma or chronic obstructive pulmonary disease (COPD)
- Major cardiac conditions, such as recent myocardial infarction or a left ventricular ejection fraction (EF) less than 55%
- Atrioventricular blocks of second and third degrees
- Allergies to any drugs
- Severe neurological disorders
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 |
|---|---|---|
| SevofluraneSevoflurane was managed for maintenance of the general anestesia during spinal surgeries | Drug | Sevoflurane Group |
| TIVAAlso: Total Intra Venous AnesthesiaTIVA was managed for maintenance of the general anesthesia during spinal surgeries | Drug | TIVA group |
Primary outcome
PEEP
Time frame: 5, 15, and 30 minutes after positioning in the prone position
positive end-expiratory pressure
ETCO2
Time frame: 5, 15, and 30 minutes after positioning in the prone position
end-tidal carbon dioxide
VT
Time frame: 5, 15, and 30 minutes after positioning in the prone position
tidal volume
Ppeak
Time frame: 5, 15, and 30 minutes after positioning in the prone position
peak airway pressure
Pmean
Time frame: 5, 15, and 30 minutes after positioning in the prone position
mean airway pressure
RR
Time frame: 5, 15, and 30 minutes after positioning in the prone position
Respiratory Rate
MV
Time frame: 5, 15, and 30 minutes after positioning in the prone position
Minute volume
Cdyn
Time frame: in the supine position after intubation and in the prone position at the 30th minute
Dynamic. compliance
PaO2/FiO2
Time frame: in the prone position at the 30th minute
Partial Oxygen pressure/traction of inspired oxygen
Vd/Vt
Time frame: in the prone position at the 30th minute
dead space/tidal volume
3 secondary outcomes
HR
Time frame: 5, 15, and 30 minutes after positioning in the prone position
SBP
Time frame: 5, 15, and 30 minutes after positioning in the prone position
DBP
Time frame: 5, 15, and 30 minutes after positioning in the prone position
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 19 Aug 2024.
- 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.
Yücel Yüce, MD,Assoc Prf principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane and TIVA in people with Spinal Stenosis, Lumbosacral Region, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 6 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 19 Aug 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 Turkey (Türkiye). 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?
PEEP (time frame: 5, 15, and 30 minutes after positioning in the prone position). The study lists 10 primary outcomes in all. 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 19 Aug 2024.