Pain, AcuteSedNOLNCT06963749
Surgical Intervention in Deep Sedation: No Pain or no Memory
An observational study of Pain, Acute and Surgical Procedure, Unspecified, run by ASL Novara at 1 site in Italy.
Trial summary
The goal of this observational study is to assess the levels of nociception in deeply sedated patients who need painful and short-duration surgical procedure. The main question it aims to answer is to verify that the sedative protocols used in clinical practice are sufficiently effective also in terms of nociception. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Surgical Procedure, Unspecified
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to 31 Jan 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of patients from the Ss. Trinità Hospital in Borgomanero between March 1, 2024, and August 31, 2024, who are to undergo surgical procedures lasting less than 90 minutes and particularly painful, with an indication for deep sedation anesthesia.
Who may be able to join
- Adult patient
- ASA Physical Status I - II - III
Who cannot join
- ASA Physical Status IV
- Pregnant and breastfeeding patients
- Pre-existing cardiac arrhythmias
- Patients with neuromuscular diseases
- Patients with psychiatric syndromes under pharmacological treatment
- Patients with chronic use of analgesics
Show all 9Show fewer
- Patients with a history of drug abuse
- Allergy to one or more drugs used in the protocol
- Refusal to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Control During Brief Intervention in Deep Sedation: no Pain or no Memory
The goal of this observational study is to assess the levels of nociception in deeply sedated patients who need painful and short-duration surgical procedure.
The main question it aims to answer is to verify that the sedative protocols used in clinical practice are sufficiently effective also in terms of nociception.
Participants will deeply sedated and monitored with PMD-200™ to detect the nociception level (NOL Index).
Read the detailed description
Prior to enrollment, upon arrival in the operating room and after being properly positioned on the operating table, patients will undergo standard intraoperative monitoring with pulse oximetry (SpO2), 3-lead electrocardiography (ECG), non-invasive brachial blood pressure monitoring (BP), a sensor for the Bispectral Index (BIS), and a nociception sensor (NOL) will also be placed.
Patients will be pre-oxygenated with a face mask with inspired oxygen fraction (FiO2) at 100% for 3 minutes.
The induction phase of deep sedation anesthesia will be conducted with a single bolus of Fentanyl 1 mcg/kg and total intravenous anaesthesia - target controlled infusion (TIVA-TCI) Propofol with an effect site concentration (Cε) of 4.0 mcg/mL.
Once the sedation level shows a Bispectral Index between 40 and 60, observation of the NOL Index will begin.
Subsequently, the laryngeal mask can be positioned, mechanical ventilation started, and the surgical procedure commenced.
During this phase, the maintenance of the anesthetic plan will be ensured by the infusion of Propofol in TIVA-TCI (with a Cε that keeps the BIS between 40 and 60) and the administration of Paracetamol 1 g, Ketorolac 30 mg, and Dexamethasone 4 mg.
At the end of the surgical procedure, the observation of the NOL Index will conclude.
Upon awakening, patients will be taken to the Post-Anesthesia Care Unit (PACU), where they will remain until their vital parameters are stabilized. At this point, 15 minutes post-operatively, the intensity of pain will be recorded using the numeric pain rating scale (NRS) scale.
Subsequently, patients will be transferred to the ward, where, 2 hours post-operatively, they will be interviewed about the intensity of post-operative pain and whether they need any rescue analgesic doses.
Data collection and management will be handled by the investigator and/or the designated study staff.
Data will be collected directly into a digital file (spreadsheet - MS Excel - Microsoft, Redmond, CA) without the use of paper forms.
Data will be collected anonymously without identifying codes that could link to the patient's medical record and identity. The correspondence list between demographic data and the patients' identification codes will be kept at the enrolling center and will only be accessible to the study staff.
The data to be collected include the following:
- Anthropometric Data:
- Sex
- Age
- Weight
- Height
- Body Mass Index (BMI)
- American Society of Anesthesiologists (ASA) Physical Status
- Clinical Data
- Surgical Procedure Performed
- Heart Rate (HR)
- Non-Invasive Blood Pressure (BP)
- Pulse Oximetry (SpO2)
- Bispectral Index (BIS)
- NOL Index
- NRS Pain Scale
Continuous variables will be presented as mean and standard deviation or as median and interquartile range depending on their distribution. Normal distribution will be assessed using the Kolmogorov-Smirnov test. Any sub-analyses and comparisons between sub-groups will be conducted using the Student's t-test for parametric data, while the Mann-Whitney test will be used for non-parametric data. Categorical variables will be presented as absolute numbers and percentages of the total sample. Any sub-analyses and comparisons between sub-groups will be conducted using the Chi-square test or Fisher's exact test, depending on the size of the sub-groups. In all cases, the null hypothesis will be rejected for α values <0.05. The software used for data analysis and sample size calculation is MedCalc v. 22.013 (MedCalc Software, Ostend, Belgium).
- Conditions
- Pain, Acute, Surgical Procedure, Unspecified
- Keywords
- Deep sedation, Nociception, NOL index, Pain control
- Medical subject headings
- Acute Pain, Agnosia
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 |
|---|---|---|
| Study group | All patients meeting the inclusion criteria who underwent surgical brief procedures in deep sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
High level of nociception
The sedation protocol used will be considered ineffective in terms of nociception if the percentage of time during which the NOL index exceeds the threshold of 25, relative to the observation time, is greater than 25%.
Measured: The interval between reaching the appropriate level of sedation (Bispectral Index - BIS between 40 and 60) and the end of the surgical stimulation.
Secondary outcomes (2)
NOL Index >25
Time in minutes during which the NOL index exceeds the threshold of 25
Measured: The interval between reaching the appropriate level of sedation (Bispectral Index - BIS between 40 and 60) and the end of the surgical stimulation.
NOL Index Peaks
Number of peaks with a NOL index greater than 40
Measured: The interval between reaching the appropriate level of sedation (Bispectral Index - BIS between 40 and 60) and the end of the surgical stimulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 Mar 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASL Novara
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Davide Colombo, ASL Novara
- Investigators
- Davide Colombo, PhD, Study director, ASL Novara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963749
- Sponsor's protocol ID
- SedNol
- Acronym
- SedNOL
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2024
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coluzzi F. Intraoperative nociception: "if you can't measure it, you can't manage it". Minerva Anestesiol. 2019 May;85(5):462-464. doi: 10.23736/S0375-9393.19.13612-7. Epub 2019 Feb 13. No abstract available.
PubMed 30762333Ghanty I, Schraag S. The quantification and monitoring of intraoperative nociception levels in thoracic surgery: a review. J Thorac Dis. 2019 Sep;11(9):4059-4071. doi: 10.21037/jtd.2019.08.62.
PubMed 31656682Klein AA, Meek T, Allcock E, Cook TM, Mincher N, Morris C, Nimmo AF, Pandit JJ, Pawa A, Rodney G, Sheraton T, Young P. Recommendations for standards of monitoring during anaesthesia and recovery 2021: Guideline from the Association of Anaesthetists. Anaesthesia. 2021 Sep;76(9):1212-1223. doi: 10.1111/anae.15501. Epub 2021 May 20.
PubMed 34013531Meijer FS, Martini CH, Broens S, Boon M, Niesters M, Aarts L, Olofsen E, van Velzen M, Dahan A. Nociception-guided versus Standard Care during Remifentanil-Propofol Anesthesia: A Randomized Controlled Trial. Anesthesiology. 2019 May;130(5):745-755. doi: 10.1097/ALN.0000000000002634.
PubMed 30829658Meijer F, Honing M, Roor T, Toet S, Calis P, Olofsen E, Martini C, van Velzen M, Aarts L, Niesters M, Boon M, Dahan A. Reduced postoperative pain using Nociception Level-guided fentanyl dosing during sevoflurane anaesthesia: a randomised controlled trial. Br J Anaesth. 2020 Dec;125(6):1070-1078. doi: 10.1016/j.bja.2020.07.057. Epub 2020 Sep 17.
PubMed 32950246Won YJ, Lim BG, Lee SH, Park S, Kim H, Lee IO, Kong MH. Comparison of relative oxycodone consumption in surgical pleth index-guided analgesia versus conventional analgesia during sevoflurane anesthesia: A randomized controlled trial. Medicine (Baltimore). 2016 Aug;95(35):e4743. doi: 10.1097/MD.0000000000004743.
PubMed 27583920
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Control During Brief Intervention in Deep Sedation: no Pain or no Memory
- ClinicalTrials.gov ID
- NCT06963749
- Acronym / sponsor ID
- SedNOL / SedNol
- Conditions
- Pain, Acute, Surgical Procedure, Unspecified
- Keywords
- Deep sedation, Nociception, NOL index, Pain control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- ASL NovaraOther government
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 9 May 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 goal of this observational study is to assess the levels of nociception in deeply sedated patients who need painful and short-duration surgical procedure.
The main question it aims to answer is to verify that the sedative protocols used in clinical practice are sufficiently effective also in terms of nociception.
Participants will deeply sedated and monitored with PMD-200™ to detect the nociception level (NOL Index).
Detailed description
Prior to enrollment, upon arrival in the operating room and after being properly positioned on the operating table, patients will undergo standard intraoperative monitoring with pulse oximetry (SpO2), 3-lead electrocardiography (ECG), non-invasive brachial blood pressure monitoring (BP), a sensor for the Bispectral Index (BIS), and a nociception sensor (NOL) will also be placed.
Patients will be pre-oxygenated with a face mask with inspired oxygen fraction (FiO2) at 100% for 3 minutes.
The induction phase of deep sedation anesthesia will be conducted with a single bolus of Fentanyl 1 mcg/kg and total intravenous anaesthesia - target controlled infusion (TIVA-TCI) Propofol with an effect site concentration (Cε) of 4.0 mcg/mL.
Once the sedation level shows a Bispectral Index between 40 and 60, observation of the NOL Index will begin.
Subsequently, the laryngeal mask can be positioned, mechanical ventilation started, and the surgical procedure commenced.
During this phase, the maintenance of the anesthetic plan will be ensured by the infusion of Propofol in TIVA-TCI (with a Cε that keeps the BIS between 40 and 60) and the administration of Paracetamol 1 g, Ketorolac 30 mg, and Dexamethasone 4 mg.
At the end of the surgical procedure, the observation of the NOL Index will conclude.
Upon awakening, patients will be taken to the Post-Anesthesia Care Unit (PACU), where they will remain until their vital parameters are stabilized. At this point, 15 minutes post-operatively, the intensity of pain will be recorded using the numeric pain rating scale (NRS) scale.
Subsequently, patients will be transferred to the ward, where, 2 hours post-operatively, they will be interviewed about the intensity of post-operative pain and whether they need any rescue analgesic doses.
Data collection and management will be handled by the investigator and/or the designated study staff.
Data will be collected directly into a digital file (spreadsheet - MS Excel - Microsoft, Redmond, CA) without the use of paper forms.
Data will be collected anonymously without identifying codes that could link to the patient's medical record and identity. The correspondence list between demographic data and the patients' identification codes will be kept at the enrolling center and will only be accessible to the study staff.
The data to be collected include the following:
- Anthropometric Data:
- Sex
- Age
- Weight
- Height
- Body Mass Index (BMI)
- American Society of Anesthesiologists (ASA) Physical Status
- Clinical Data
- Surgical Procedure Performed
- Heart Rate (HR)
- Non-Invasive Blood Pressure (BP)
- Pulse Oximetry (SpO2)
- Bispectral Index (BIS)
- NOL Index
- NRS Pain Scale
Continuous variables will be presented as mean and standard deviation or as median and interquartile range depending on their distribution. Normal distribution will be assessed using the Kolmogorov-Smirnov test. Any sub-analyses and comparisons between sub-groups will be conducted using the Student's t-test for parametric data, while the Mann-Whitney test will be used for non-parametric data. Categorical variables will be presented as absolute numbers and percentages of the total sample. Any sub-analyses and comparisons between sub-groups will be conducted using the Chi-square test or Fisher's exact test, depending on the size of the sub-groups. In all cases, the null hypothesis will be rejected for α values <0.05. The software used for data analysis and sample size calculation is MedCalc v. 22.013 (MedCalc Software, Ostend, Belgium).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –All patients meeting the inclusion criteria who underwent surgical brief procedures in deep sedation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients from the Ss. Trinità Hospital in Borgomanero between March 1, 2024, and August 31, 2024, who are to undergo surgical procedures lasting less than 90 minutes and particularly painful, with an indication for deep sedation anesthesia.
Key inclusion criteria (2 listed)
- Adult patient
- ASA Physical Status I - II - III
Key exclusion criteria (9 listed)
- ASA Physical Status IV
- Pregnant and breastfeeding patients
- Pre-existing cardiac arrhythmias
- Patients with neuromuscular diseases
- Patients with psychiatric syndromes under pharmacological treatment
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
High level of nociception
Time frame: The interval between reaching the appropriate level of sedation (Bispectral Index - BIS between 40 and 60) and the end of the surgical stimulation.
The sedation protocol used will be considered ineffective in terms of nociception if the percentage of time during which the NOL index exceeds the threshold of 25, relative to the observation time, is greater than 25%.
2 secondary outcomes
NOL Index >25
Time frame: The interval between reaching the appropriate level of sedation (Bispectral Index - BIS between 40 and 60) and the end of the surgical stimulation.
NOL Index Peaks
Time frame: The interval between reaching the appropriate level of sedation (Bispectral Index - BIS between 40 and 60) and the end of the surgical stimulation.
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 6 Aug 2025.
- Background: PubMed 30762333Coluzzi F. Intraoperative nociception: "if you can't measure it, you can't manage it". Minerva Anestesiol. 2019 May;85(5):462-464. doi: 10.23736/S0375-9393.19.13612-7. Epub 2019 Feb 13. No abstract available.
- Background: PubMed 31656682Ghanty I, Schraag S. The quantification and monitoring of intraoperative nociception levels in thoracic surgery: a review. J Thorac Dis. 2019 Sep;11(9):4059-4071. doi: 10.21037/jtd.2019.08.62.
- Background: PubMed 34013531Klein AA, Meek T, Allcock E, Cook TM, Mincher N, Morris C, Nimmo AF, Pandit JJ, Pawa A, Rodney G, Sheraton T, Young P. Recommendations for standards of monitoring during anaesthesia and recovery 2021: Guideline from the Association of Anaesthetists. Anaesthesia. 2021 Sep;76(9):1212-1223. doi: 10.1111/anae.15501. Epub 2021 May 20.
- Background: PubMed 30829658Meijer FS, Martini CH, Broens S, Boon M, Niesters M, Aarts L, Olofsen E, van Velzen M, Dahan A. Nociception-guided versus Standard Care during Remifentanil-Propofol Anesthesia: A Randomized Controlled Trial. Anesthesiology. 2019 May;130(5):745-755. doi: 10.1097/ALN.0000000000002634.
- Background: PubMed 32950246Meijer F, Honing M, Roor T, Toet S, Calis P, Olofsen E, Martini C, van Velzen M, Aarts L, Niesters M, Boon M, Dahan A. Reduced postoperative pain using Nociception Level-guided fentanyl dosing during sevoflurane anaesthesia: a randomised controlled trial. Br J Anaesth. 2020 Dec;125(6):1070-1078. doi: 10.1016/j.bja.2020.07.057. Epub 2020 Sep 17.
- Background: PubMed 27583920Won YJ, Lim BG, Lee SH, Park S, Kim H, Lee IO, Kong MH. Comparison of relative oxycodone consumption in surgical pleth index-guided analgesia versus conventional analgesia during sevoflurane anesthesia: A randomized controlled trial. Medicine (Baltimore). 2016 Aug;95(35):e4743. doi: 10.1097/MD.0000000000004743.
- Statement on Continuum of Depth of Sedation: Definition of General Anesthesia and Levels of Sedation/AnalgesiaLink provided by the sponsor.
- General AnesthesiaLink provided by the sponsor.
- 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.
Davide Colombo, PhD study director
ASL Novara
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 Pain, Acute and Surgical Procedure, Unspecified, run by ASL Novara at 1 site in Italy.
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 9 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 6 Aug 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 Italy. 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?
High level of nociception (time frame: The interval between reaching the appropriate level of sedation (Bispectral Index - BIS between 40 and 60) and the end of the surgical stimulation.). 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 NCT06963749, which also lists 6 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 6 Aug 2025.