PainNCT07075003
NOL-Guided vs Conventional Intraoperative Opioid Infusion on Outcomes in Geriatric Patients
An observational study of Pain and Opioid Use, run by Saglik Bilimleri Universitesi.
Trial summary
The aim of this study is to compare the effects of conventional methods and goal-directed therapy guided by pain monitoring on total remifentanil dosage, wake-up time, and complications in geriatric patients undergoing lumbar stabilization surgery. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Pain, Opioid Use, Geriatric Anesthesia
- What is being tested?
- nociceptive level
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- Older adult
Study population: A total of 80 geriatric patients undergoing lumbar stabilization surgery
Who may be able to join
- Patients undergoing lumbar stabilization surgery
Who cannot join
- Chronic opioid use
- Severe congestive heart failıure
- Severe arrhythmia
- Uncontrolled hypertension
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of NOL-Guided vs Conventional Intraoperative Opioid Infusion on Outcomes in Geriatric Patients Undergoing Lumbar Stabilization Surgery
The aim of this study is to compare the effects of conventional methods and goal-directed therapy guided by pain monitoring on total remifentanil dosage, wake-up time, and complications in geriatric patients undergoing lumbar stabilization surgery.
Read the detailed description
With the aging population, the number of geriatric patients undergoing surgery is increasing daily. One of the anesthesiologists' main responsibilities is to prevent intraoperative pain and related complications. Opioids have been known for thousands of years as valuable tools for pain management and remain the cornerstone of perioperative analgesia today (1). Remifentanil is currently the most commonly used opioid during the intraoperative period due to its potent analgesic properties, short duration of action, and metabolism by plasma enzymes. While it may improve hemodynamic stability, remifentanil can also cause hypotension and bradycardia. Prolonged remifentanil use may lead to hyperalgesia, increasing the need for postoperative opioid analgesics and consequently leading to opioid-related side effects. In elderly patients, changes in body composition, drug sensitivity, and hepatic/renal metabolism require more cautious opioid administration.
Optimizing remifentanil infusion dosing during surgery may reduce total opioid consumption and thus decrease side effects such as wake-up time, postoperative pain, and nausea.
In conventional use, remifentanil is administered as a continuous infusion, and dosage adjustments are made based on heart rate and blood pressure changes to estimate pain levels. However, with goal-directed therapy guided by pain monitoring, more effective analgesia can be achieved. These applications are selected based on the clinician's experience and preferences. While some publications report that total remifentanil use decreases in patients with dose adjustments guided by pain monitoring, evidence is lacking regarding which method is superior in terms of patient outcomes in elderly populations.The aim of this study is to compare the effects of conventional methods and goal-directed therapy guided by pain monitoring on total remifentanil dosage, wake-up time, and complications in geriatric patients undergoing lumbar stabilization surgery.
After obtaining informed consent, a total of 80 geriatric patients undergoing lumbar stabilization surgery will be included. Once on the operating table, all patients will receive standard monitoring including peripheral oxygen saturation, non-invasive blood pressure, ECG, and anesthesia depth. All patients will receive intravenous 2-2.5 mg/kg propofol under Sedline guidance, and remifentanil via target-controlled infusion at an effect-site concentration of 4 ng/ml. After anesthesia depth falls below 50, 0.6 mg/kg rocuronium will be administered. Maintenance anesthesia will be with 1-2% sevoflurane in 40/60% oxygen/air mixture at 2 L flow. The method of remifentanil administration will be determined by the attending anesthesiologist.
Demographic data (age, height, weight, gender, comorbidities, ASA score) will be recorded. Hemodynamic parameters (blood pressure, heart rate, oxygen saturation, end-tidal CO₂), remifentanil dosage, and NOL levels (for Group 2) will be recorded every 15 minutes during the surgery. At the end of surgery, the following will be documented:
Total remifentanil dosage Blood loss and transfusion volume Number of hypotensive events (MAP <55) Wake-up time Total surgical time NRS (Numerical Rating Scale) pain scores Nausea-vomiting scores
In the post-anesthesia care unit (PACU), pain and nausea-vomiting scores will be evaluated at the 10th, 20th, and 30th minutes, along with duration of PACU stay. During ward follow-up, pain scores, nausea-vomiting scores, administered medications, and length of postoperative hospital stay will be recorded at 1, 3, 6, and 24 hours.
Nausea-vomiting will be assessed using a 4-point scale:
0: none
- nausea without vomiting
- nausea with vomiting
- vomiting more than twice
Pain will be assessed using the NRS scale.
- Conditions
- Pain, Opioid Use, Geriatric Anesthesia
- Being tested
- nociceptive level
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nociceptive levelDevice
remifentanil infusion dose adjustment according to the changes of nociceptive level
| Study group | Role | What they receive |
|---|---|---|
| Conservative | Our clinic's standard anesthesia induction and maintenance method will be applied to all patients. Patients will receive standard monitoring including peripheral oxygen saturation, non-invasive blood pressure, ECG, and anesthesia depth. All patients will receive intravenous 2-2.5 mg/kg propofol under Sedline guidance, and remifentanil via target-controlled infusion at an effect-site concentration of 4 ng/ml. After anesthesia depth falls below 50, 0.6 mg/kg rocuronium will be administered. Maintenance anesthesia will be with 1-2% sevoflurane in 40/60% oxygen/air mixture at 2 L flow.Remifentanil is administered as a continuous infusion in conservative approach;dosage adjustments are made based on heart rate and blood pressure changes to estimate pain levels. | |
| Nociceptive level | Our clinic's standard anesthesia induction and maintenance method will be applied to all patients. Patients will receive standard monitoring including peripheral oxygen saturation, non-invasive blood pressure, ECG, and anesthesia depth. All patients will receive intravenous 2-2.5 mg/kg propofol under Sedline guidance, and remifentanil via target-controlled infusion at an effect-site concentration of 4 ng/ml. After anesthesia depth falls below 50, 0.6 mg/kg rocuronium will be administered. Maintenance anesthesia will be with 1-2% sevoflurane in 40/60% oxygen/air mixture at 2 L flow.Remifentanil is administered as a continuous infusion by using Nociceptive level guidance Receives: Device: nociceptive level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose
Total dose of remifentanil used in operation
Measured: operation duration
Secondary outcomes (2)
postoperative pain
pain evaluation during postoperative 24 hour,
11 point Numeric Rating Scale (NRS) will be used to measure pain level (0-10) 0: No pain, 10: Worst possible pain
Measured: postoperative 10th, 20th, and 30th minutes, 1, 3, 6, and 24 hours
nausea and vomiting
postoperative nausea and vomiting
Nausea-vomiting will be assessed using a 4-point scale:
0: none
- nausea without vomiting
- nausea with vomiting
- vomiting more than twice
Measured: postoperative 10th, 20th, and 30th minutes, 1, 3, 6, and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Süheyla Abitağaoğlu, Saglik Bilimleri Universitesi
- Investigators
- Süheyla Abitağaoğlu, Principal investigator, UNIVERSİTY OF HEALTH SCIENCES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075003
- Sponsor's protocol ID
- sabitagaoglu
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gazelka HM, Leal JC, Lapid MI, Rummans TA. Opioids in Older Adults: Indications, Prescribing, Complications, and Alternative Therapies for Primary Care. Mayo Clin Proc. 2020 Apr;95(4):793-800. doi: 10.1016/j.mayocp.2020.02.002.
PubMed 32247352Hwang W, Lee J, Park J, Joo J. Dexmedetomidine versus remifentanil in postoperative pain control after spinal surgery: a randomized controlled study. BMC Anesthesiol. 2015 Feb 24;15:21. doi: 10.1186/s12871-015-0004-1. eCollection 2015.
PubMed 25750586Mercadante S. Influence of aging on opioid dosing for perioperative pain management: a focus on pharmacokinetics. J Anesth Analg Crit Care. 2024 Aug 1;4(1):51. doi: 10.1186/s44158-024-00182-2.
PubMed 39085914
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of NOL-Guided vs Conventional Intraoperative Opioid Infusion on Outcomes in Geriatric Patients Undergoing Lumbar Stabilization Surgery
- ClinicalTrials.gov ID
- NCT07075003
- Acronym / sponsor ID
- sabitagaoglu
- Conditions
- Pain, Opioid Use, Geriatric Anesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 20 Jul 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.
The aim of this study is to compare the effects of conventional methods and goal-directed therapy guided by pain monitoring on total remifentanil dosage, wake-up time, and complications in geriatric patients undergoing lumbar stabilization surgery.
Detailed description
With the aging population, the number of geriatric patients undergoing surgery is increasing daily. One of the anesthesiologists' main responsibilities is to prevent intraoperative pain and related complications. Opioids have been known for thousands of years as valuable tools for pain management and remain the cornerstone of perioperative analgesia today (1). Remifentanil is currently the most commonly used opioid during the intraoperative period due to its potent analgesic properties, short duration of action, and metabolism by plasma enzymes. While it may improve hemodynamic stability, remifentanil can also cause hypotension and bradycardia. Prolonged remifentanil use may lead to hyperalgesia, increasing the need for postoperative opioid analgesics and consequently leading to opioid-related side effects. In elderly patients, changes in body composition, drug sensitivity, and hepatic/renal metabolism require more cautious opioid administration.
Optimizing remifentanil infusion dosing during surgery may reduce total opioid consumption and thus decrease side effects such as wake-up time, postoperative pain, and nausea.
In conventional use, remifentanil is administered as a continuous infusion, and dosage adjustments are made based on heart rate and blood pressure changes to estimate pain levels. However, with goal-directed therapy guided by pain monitoring, more effective analgesia can be achieved. These applications are selected based on the clinician's experience and preferences. While some publications report that total remifentanil use decreases in patients with dose adjustments guided by pain monitoring, evidence is lacking regarding which method is superior in terms of patient outcomes in elderly populations.The aim of this study is to compare the effects of conventional methods and goal-directed therapy guided by pain monitoring on total remifentanil dosage, wake-up time, and complications in geriatric patients undergoing lumbar stabilization surgery.
After obtaining informed consent, a total of 80 geriatric patients undergoing lumbar stabilization surgery will be included. Once on the operating table, all patients will receive standard monitoring including peripheral oxygen saturation, non-invasive blood pressure, ECG, and anesthesia depth. All patients will receive intravenous 2-2.5 mg/kg propofol under Sedline guidance, and remifentanil via target-controlled infusion at an effect-site concentration of 4 ng/ml. After anesthesia depth falls below 50, 0.6 mg/kg rocuronium will be administered. Maintenance anesthesia will be with 1-2% sevoflurane in 40/60% oxygen/air mixture at 2 L flow. The method of remifentanil administration will be determined by the attending anesthesiologist.
Demographic data (age, height, weight, gender, comorbidities, ASA score) will be recorded. Hemodynamic parameters (blood pressure, heart rate, oxygen saturation, end-tidal CO₂), remifentanil dosage, and NOL levels (for Group 2) will be recorded every 15 minutes during the surgery. At the end of surgery, the following will be documented:
Total remifentanil dosage Blood loss and transfusion volume Number of hypotensive events (MAP <55) Wake-up time Total surgical time NRS (Numerical Rating Scale) pain scores Nausea-vomiting scores
In the post-anesthesia care unit (PACU), pain and nausea-vomiting scores will be evaluated at the 10th, 20th, and 30th minutes, along with duration of PACU stay. During ward follow-up, pain scores, nausea-vomiting scores, administered medications, and length of postoperative hospital stay will be recorded at 1, 3, 6, and 24 hours.
Nausea-vomiting will be assessed using a 4-point scale:
0: none
- nausea without vomiting
- nausea with vomiting
- vomiting more than twice
Pain will be assessed using the NRS scale.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative | – | –Our clinic's standard anesthesia induction and maintenance method will be applied to all patients. Patients will receive standard monitoring including peripheral oxygen saturation, non-invasive blood pressure, ECG, and anesthesia depth. All patients will receive intravenous 2-2.5 mg/kg propofol under Sedline guidance, and remifentanil via target-controlled infusion at an effect-site concentration of 4 ng/ml. After anesthesia depth falls below 50, 0.6 mg/kg rocuronium will be administered. Maintenance anesthesia will be with 1-2% sevoflurane in 40/60% oxygen/air mixture at 2 L flow.Remifentanil is administered as a continuous infusion in conservative approach;dosage adjustments are made based on heart rate and blood pressure changes to estimate pain levels. |
| Nociceptive level | – | Device: nociceptive levelOur clinic's standard anesthesia induction and maintenance method will be applied to all patients. Patients will receive standard monitoring including peripheral oxygen saturation, non-invasive blood pressure, ECG, and anesthesia depth. All patients will receive intravenous 2-2.5 mg/kg propofol under Sedline guidance, and remifentanil via target-controlled infusion at an effect-site concentration of 4 ng/ml. After anesthesia depth falls below 50, 0.6 mg/kg rocuronium will be administered. Maintenance anesthesia will be with 1-2% sevoflurane in 40/60% oxygen/air mixture at 2 L flow.Remifentanil is administered as a continuous infusion by using Nociceptive level guidance |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Age groups
- Older adult
- Study population
- A total of 80 geriatric patients undergoing lumbar stabilization surgery
Key inclusion criteria (1 listed)
- Patients undergoing lumbar stabilization surgery
Key exclusion criteria (4 listed)
- Chronic opioid use
- Severe congestive heart failıure
- Severe arrhythmia
- Uncontrolled hypertension
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 |
|---|---|---|
| nociceptive levelremifentanil infusion dose adjustment according to the changes of nociceptive level | Device | Nociceptive level |
Primary outcome
Total dose
Time frame: operation duration
Total dose of remifentanil used in operation
2 secondary outcomes
postoperative pain
Time frame: postoperative 10th, 20th, and 30th minutes, 1, 3, 6, and 24 hours
nausea and vomiting
Time frame: postoperative 10th, 20th, and 30th minutes, 1, 3, 6, and 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Background: PubMed 32247352Gazelka HM, Leal JC, Lapid MI, Rummans TA. Opioids in Older Adults: Indications, Prescribing, Complications, and Alternative Therapies for Primary Care. Mayo Clin Proc. 2020 Apr;95(4):793-800. doi: 10.1016/j.mayocp.2020.02.002.
- Background: PubMed 25750586Hwang W, Lee J, Park J, Joo J. Dexmedetomidine versus remifentanil in postoperative pain control after spinal surgery: a randomized controlled study. BMC Anesthesiol. 2015 Feb 24;15:21. doi: 10.1186/s12871-015-0004-1. eCollection 2015.
- Background: PubMed 39085914Mercadante S. Influence of aging on opioid dosing for perioperative pain management: a focus on pharmacokinetics. J Anesth Analg Crit Care. 2024 Aug 1;4(1):51. doi: 10.1186/s44158-024-00182-2.
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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.
Süheyla Abitağaoğlu principal investigator
UNIVERSİTY OF HEALTH SCIENCES
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Opioid Use, run by Saglik Bilimleri Universitesi.
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 4 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: opening soon, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Süheyla Abitağaoğlu (05325267656, suheylaatay81@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total dose (time frame: operation duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07075003, which also lists 3 linked publications.
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 20 Jul 2025.