AnesthesiaTIVANCT06781177
Comparison of Total Intravenous Anesthesia Methods in Spinal Surgery (TIVA)
An observational study of Anesthesia, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the effects of the classical Total Intravenous Anesthesia (TIVA) method and multimodal anesthesia protocols created by adding lidocaine and ketamine infusions on postoperative pain management, opioid consumption, and surgical recovery in posterior thoracolumbar spinal fusion surgeries. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2023to 10 Nov 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18 years or older, classified as ASA I-III, undergoing posterior thoracolumbar spinal surgery and neuromonitoring under general anesthesia, and fluent in Turkish.
Who may be able to join
- Aged 18 years or older,
- ASA classification I-III
- Patients undergoing posterior thoracolumbar spinal surgery and neuromonitoring under general anesthesia
Who cannot join
- Emergency operations
- Pregnant patients
- Patients with ASA classification IV or higher*
- Patients allergic to morphine and local anesthetics
- Patients with neurological or psychiatric disorders (on ongoing antidepressant and/or anticonvulsant therapy) Illiterate patients
- Patients unable to cooperate
Show all 12Show fewer
- Extremely low or high body weight (less than 40 kg or more than 100 kg)
- Chronic opioid use
- Diabetes mellitus (DM) requiring insulin therapy
- Chronic alcohol use
- Patients with peripheral neuropathy
- Patients with cardiac arrhythmias
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr Abdurrahman Yurtaslan Oncology Hospital
Ankara, Yenimahalle, 06200
About this study
Official title: Comparison of Total Intravenous Anesthesia Methods in Terms of Postoperative Outcomes in Thoracolumbar Spinal Surgery Cases
This study aims to compare the effects of the classical Total Intravenous Anesthesia (TIVA) method and multimodal anesthesia protocols created by adding lidocaine and ketamine infusions on postoperative pain management, opioid consumption, and surgical recovery in posterior thoracolumbar spinal fusion surgeries.
A prospective observational study was conducted with 72 patients undergoing posterior thoracolumbar spinal fusion surgeries. Patients were evenly divided into three groups: classical TIVA (propofol and remifentanil), TIVA + ketamine, and TIVA + lidocaine. Hemodynamic parameters and drug dosages were recorded during the intraoperative period, while pain scores, opioid consumption, time to first ambulation and bowel movement, as well as nausea-vomiting and sedation scores, were documented postoperatively.
- Conditions
- Anesthesia
- Keywords
- Anesthesia, Intravenous, Bispectral Index Monitor, Ketamine, Lidocaine, Spinal Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group S | Propofol at 30-100 mcg/kg/min and remifentanil at 0.05-0.2 mcg/kg/min (classical TIVA) | |
| Group K | Propofol at 30-100 mcg/kg/min, remifentanil at 0.05-0.1 mcg/kg/min, ketamine at 5 mcg/kg/min | |
| Group L | Propofol at 30-100 mcg/kg/min, remifentanil at 0.05-0.1 mcg/kg/min, lidocaine at 1.2 mg/kg/h |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score Using Visual Analog Scale (VAS)
Pain levels will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), at 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours postoperatively.
Measured: postoperative 24 hours
Total Opioid Consumption in the First 24 Hours Postoperatively
The total amount of opioids administered during the first 24 hours postoperatively will be recorded and converted to morphine milligram equivalents (MME).
Measured: Postoperative 24 hours
Secondary outcomes (4)
Time to First Ambulation After Surgery
The time from the end of surgery to the patient's first ambulation will be recorded in hours.
Measured: postoperative 24 hours
Time to First Bowel Movement After Surgery
The time from the end of surgery to the patient's first reported bowel movement will be recorded in hours.
Measured: postoperative 24 hours
Incidence of Nausea and Vomiting
The presence of postoperative nausea and vomiting will be recorded within the first 24 hours after surgery.
Measured: postoperative 24 hours
Opioid Requirement Within After Surgery
The need for opioid use within 1 month after discharge will be evaluated through follow-up phone calls. The percentage of patients requiring opioids during this period will be recorded.
Measured: postoperative 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start10 May 2023
- Primary completion10 Nov 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysegul Danaci, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781177
- Sponsor's protocol ID
- 2023-05/204
- Acronym
- TIVA
- Status last verified
- Jan 2025
- First submitted
- 29 Dec 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Total Intravenous Anesthesia Methods in Terms of Postoperative Outcomes in Thoracolumbar Spinal Surgery Cases
- ClinicalTrials.gov ID
- NCT06781177
- Acronym / sponsor ID
- TIVA / 2023-05/204
- Conditions
- Anesthesia
- Keywords
- Anesthesia, Intravenous, Bispectral Index Monitor, Ketamine, Lidocaine, Spinal Fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 17 Jan 2025 (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.
This study aims to compare the effects of the classical Total Intravenous Anesthesia (TIVA) method and multimodal anesthesia protocols created by adding lidocaine and ketamine infusions on postoperative pain management, opioid consumption, and surgical recovery in posterior thoracolumbar spinal fusion surgeries.
A prospective observational study was conducted with 72 patients undergoing posterior thoracolumbar spinal fusion surgeries. Patients were evenly divided into three groups: classical TIVA (propofol and remifentanil), TIVA + ketamine, and TIVA + lidocaine. Hemodynamic parameters and drug dosages were recorded during the intraoperative period, while pain scores, opioid consumption, time to first ambulation and bowel movement, as well as nausea-vomiting and sedation scores, were documented postoperatively.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group S | – | –Propofol at 30-100 mcg/kg/min and remifentanil at 0.05-0.2 mcg/kg/min (classical TIVA) |
| Group K | – | –Propofol at 30-100 mcg/kg/min, remifentanil at 0.05-0.1 mcg/kg/min, ketamine at 5 mcg/kg/min |
| Group L | – | –Propofol at 30-100 mcg/kg/min, remifentanil at 0.05-0.1 mcg/kg/min, lidocaine at 1.2 mg/kg/h |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older, classified as ASA I-III, undergoing posterior thoracolumbar spinal surgery and neuromonitoring under general anesthesia, and fluent in Turkish.
Key inclusion criteria (3 listed)
- Aged 18 years or older,
- ASA classification I-III
- Patients undergoing posterior thoracolumbar spinal surgery and neuromonitoring under general anesthesia
Key exclusion criteria (12 listed)
- Emergency operations
- Pregnant patients
- Patients with ASA classification IV or higher*
- Patients allergic to morphine and local anesthetics
- Patients with neurological or psychiatric disorders (on ongoing antidepressant and/or anticonvulsant therapy) Illiterate patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Pain Score Using Visual Analog Scale (VAS)
Time frame: postoperative 24 hours
Pain levels will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), at 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours postoperatively.
Total Opioid Consumption in the First 24 Hours Postoperatively
Time frame: Postoperative 24 hours
The total amount of opioids administered during the first 24 hours postoperatively will be recorded and converted to morphine milligram equivalents (MME).
4 secondary outcomes
Time to First Ambulation After Surgery
Time frame: postoperative 24 hours
Time to First Bowel Movement After Surgery
Time frame: postoperative 24 hours
Incidence of Nausea and Vomiting
Time frame: postoperative 24 hours
Opioid Requirement Within After Surgery
Time frame: postoperative 1 month
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 17 Jan 2025.
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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?
An observational study of Anesthesia, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital 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 3 inclusion and 12 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 17 Jan 2025. 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?
Postoperative Pain Score Using Visual Analog Scale (VAS) (time frame: postoperative 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?
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 17 Jan 2025.