Intensive Care, SurgicalNCT05762666
Nociception Level Index as Monitorization of Pain at the Intensive Care
A study testing nociception level index monitor in people with Intensive Care, Surgical and Anesthesia, General, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to evaluate the effectiveness of a nociception monitor in providing adequate postoperative analgesia for patients needing critical care after surgery. Besides, the study searches to determine the difference between the amount of analgesic medication used when guided by nociception or standard… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intensive Care, Surgical, Anesthesia, General
- What is being tested?
- nociception level index monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 30 May 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) Physical Status classification I to III
- Patients who have been admitted to the postoperative intensive care unit
- Patients necessitating general anesthesia for surgery of more than 2 hours
- Patients who need mechanical ventilation for a while in intensive care follow-up
Who cannot join
- Patients with additional organ failure
- Disease that may make it difficult to wean from the ventilator when lung functions are evaluated (Pao2/fio2 value below 200)
- History of allergies to drugs used in the study protocol
- Patients receiving deep anesthesia with sedation infusion RASS -2 (unable to be awakened by uncooperative audible stimulus)
- Patients with head trauma expected to have a low postoperative Glasgow coma score
- Presence of arrhythmia
Show all 11Show fewer
- Presence of sepsis during the hospital stay
- Patients who stay more than 48 hours at the postoperative intensive care unit
- Presence of surgical complication
- Known hepatic insufficiency or decreased function
- Known renal insufficiency or decreased function
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul, Sultangazi, 34000
About this study
Official title: Pain Monitoring in Intensive Care: How the Use of Nociception Level Index Affects Treatment and Prognosis?
The aim of our study is to evaluate the effectiveness of a nociception monitor in providing adequate postoperative analgesia for patients needing critical care after surgery. Besides, the study searches to determine the difference between the amount of analgesic medication used when guided by nociception or standard pain management protocols. It is also aimed to reveal the incidence of delirium when pain management is managed under the nociception level index (NOL) guidance.
60 postoperative patients admitted to the postanesthesia care unit (PACU) after general anesthesia for surgery for more than 2 hours will be included and allocated into 2 groups(n=30): the control group (Group A) and the study group (Group B). Group Standard of care will be followed with standard monitorization only along with pain scales and receive rescue analgesia according to them. However, Group NOL will acquire NOL monitorization throughout the ICU stay and have the same rescue analgesia under NOL guidance with concurrent pain scales. Data to be recorded are total postoperative analgesic consumption, NOL values along with CPOT scores, and delirium.
Read the detailed description
the investigators designed a prospective study after approval of our Institutional ethics committee (dossier no:212-2022) and planned to allocate 60 patients (2 groups; 1:1 allocation; n=30). This study is designed under the Declaration of Helsinki and written informed consent will be obtained before surgery. Patients within the study should have general anesthesia for surgery for more than 2 hours and also planned for follow-up at the postanesthesia care unit (PACU). Among these, an investigator selects patients aged over 18 and having American society of anesthesiology (ASA) scores I-III. Exclusion criteria are refusal to participate in the study; patients with additional organ failure especially lung failure (Pao2/fio2 value below 200); history of allergies to drugs used in the study protocol; patients receiving deep anesthesia with sedation infusion RASS -2 (unable to be awakened by uncooperative audible stimulus); patients with head trauma expected to have a low postoperative Glasgow coma score (GCS); the presence of surgical complication, arrhythmia, and sepsis during the hospital stay.
Randomization is designed with concealed opaque envelope in a 1:1 ratio into 2 groups (n= 30): the control group (Group Standard of care) and the study group (Group NOL). When the inclusion/exclusion criteria are met, on the day of the surgery the anesthetist in the operating room will choose one envelope to apply the designed protocol for each group. Data obtained at the clinical follow-up will be gathered by informed nurses at the ICU. All evaluations at the surgical wards especially for delirium and cognitive dysfunction will be evaluated by the same independent anesthetist who is blind to the study groups.
All patients will receive standard analgesia protocol as 1 gr paracetamol (maximum dose 4x1 and minimum dose interval as 6 hours) and rescue analgesia as 1mg/kg tramadol (maximum dose 4x1 and minimum dose interval as 6 hours). Moreover, if analgesia is not ensured 0,05 mg/kg morphine (IV) bolus doses are planned when their pain scales or NOL values are high (NRS >4; CPOT>2; NOL >25 over 1 minute). NRS and CPOT will be used as pain scales at postoperative 6th, 8th, 12th, and 24th hours for all patients. The Group Standard will be followed with standard monitorization only along with pain scales and receive rescue analgesia according to them. However, Group NOL will acquire NOL monitorization throughout the ICU stay and have the same rescue analgesia under NOL guidance with concurrent pain scales. The total amount of analgesics used during the ICU stay will be noted. Delirium and cognitive dysfunction will be evaluated at the 24th hour before discharge by CAM-ICU score and by 4AT at the surgical ward on the postoperative 3rd day before hospital discharge.
- Conditions
- Intensive Care, Surgical, Anesthesia, General
- Being tested
- nociception level index monitor
- Keywords
- nociception level index, Postoperative pain, behavioral pain scores, pain monitoring, delirium, postoperative cognitive dysfunction
- Medical subject headings
- Pain, Postoperative, Delirium, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nociception level index monitorDevice
The nociception level index (NOL) is one of the new electrophysiological devices to asses pain-related nociception and differs with its multi-parameter evaluation. It is generated from five different parameters (heart rate, heart rate variability, skin conductance level, photo-plethysmography waveform amplitude, number of skin conductance fluctuations, and their time derivatives)
| Study group | Role | What they receive |
|---|---|---|
| Group Standart of care | No intervention | Patients will be followed with standard monitorization only along with pain scales and receive rescue analgesia according to them |
| Group Nociception level index monitor | Experimental | Patients will acquire NOL monitorization throughout the ICU stay and have the same rescue analgesia under NOL guidance with concurrent pain scales Receives: Device: nociception level index monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
critical care observation pain tool
critical care observation pain tool (CPOT) behavioral pain assessment score over 2 is accepted as pain to apply analgesia
Measured: postoperative 24 hour
number rating scale(NRS)
number rating scale(NRS) value over 4 is accepted as pain to apply analgesia
Measured: postoperative 24 hour
Secondary outcomes (3)
The total amount of analgesic drug
morphine and tramadol used at postoperative follow-up
Measured: postoperative 24 hour
Delirium
Confusion Assessment Method for the ICU (CAM-ICU) at 24th hour : outcome will be decided as positive or negative after interrogation of course of mental status, consciousness, inattention and disorganized thinking
Measured: postoperative 24th hour
cognitive dysfunction
Arousal, Attention, Abbreviated Mental Test (4AT) scores at 24th hour and postoperative 3th day: A score of 1-3 suggests cognitive impairment and a score of 4 or more suggests delirium
Measured: postoperative 24th hour and postoperative 3th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start1 Jan 2023
- Primary completion30 Apr 2023
- Study completion30 May 2023
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 Intensive Care, SurgicalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A will be followed with standard monitorization only along with pain scales and receive rescue analgesia according to them. However, Group B will acquire NOL monitorization throughout the ICU stay and have the same rescue analgesia under NOL guidance with concurrent pain scales.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berna Caliskan, MD, Principal investigator, Haseki Training and Research Hospital Anesthesiology and Reanimation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762666
- Sponsor's protocol ID
- 212-2022
- Status last verified
- Jul 2023
- First submitted
- 11 Jan 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gelinas C, Shahiri T S, Richard-Lalonde M, Laporta D, Morin JF, Boitor M, Ferland CE, Bourgault P, Richebe P. Exploration of a Multi-Parameter Technology for Pain Assessment in Postoperative Patients After Cardiac Surgery in the Intensive Care Unit: The Nociception Level Index (NOL)TM. J Pain Res. 2021 Dec 7;14:3723-3731. doi: 10.2147/JPR.S332845. eCollection 2021.
PubMed 34908872Chanques G, Gelinas C. Monitoring pain in the intensive care unit (ICU). Intensive Care Med. 2022 Oct;48(10):1508-1511. doi: 10.1007/s00134-022-06807-w. Epub 2022 Jul 29. No abstract available.
PubMed 35904563Kotfis K, van Diem-Zaal I, Williams Roberson S, Sietnicki M, van den Boogaard M, Shehabi Y, Ely EW. The future of intensive care: delirium should no longer be an issue. Crit Care. 2022 Jul 5;26(1):200. doi: 10.1186/s13054-022-04077-y.
PubMed 35790979
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Monitoring in Intensive Care: How the Use of Nociception Level Index Affects Treatment and Prognosis?
- ClinicalTrials.gov ID
- NCT05762666
- Acronym / sponsor ID
- 212-2022
- Conditions
- Intensive Care, Surgical, Anesthesia, General
- Keywords
- nociception level index, Postoperative pain, behavioral pain scores, pain monitoring, delirium, postoperative cognitive dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 9 Mar 2023 (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 our study is to evaluate the effectiveness of a nociception monitor in providing adequate postoperative analgesia for patients needing critical care after surgery. Besides, the study searches to determine the difference between the amount of analgesic medication used when guided by nociception or standard pain management protocols. It is also aimed to reveal the incidence of delirium when pain management is managed under the nociception level index (NOL) guidance.
60 postoperative patients admitted to the postanesthesia care unit (PACU) after general anesthesia for surgery for more than 2 hours will be included and allocated into 2 groups(n=30): the control group (Group A) and the study group (Group B). Group Standard of care will be followed with standard monitorization only along with pain scales and receive rescue analgesia according to them. However, Group NOL will acquire NOL monitorization throughout the ICU stay and have the same rescue analgesia under NOL guidance with concurrent pain scales. Data to be recorded are total postoperative analgesic consumption, NOL values along with CPOT scores, and delirium.
Detailed description
the investigators designed a prospective study after approval of our Institutional ethics committee (dossier no:212-2022) and planned to allocate 60 patients (2 groups; 1:1 allocation; n=30). This study is designed under the Declaration of Helsinki and written informed consent will be obtained before surgery. Patients within the study should have general anesthesia for surgery for more than 2 hours and also planned for follow-up at the postanesthesia care unit (PACU). Among these, an investigator selects patients aged over 18 and having American society of anesthesiology (ASA) scores I-III. Exclusion criteria are refusal to participate in the study; patients with additional organ failure especially lung failure (Pao2/fio2 value below 200); history of allergies to drugs used in the study protocol; patients receiving deep anesthesia with sedation infusion RASS -2 (unable to be awakened by uncooperative audible stimulus); patients with head trauma expected to have a low postoperative Glasgow coma score (GCS); the presence of surgical complication, arrhythmia, and sepsis during the hospital stay.
Randomization is designed with concealed opaque envelope in a 1:1 ratio into 2 groups (n= 30): the control group (Group Standard of care) and the study group (Group NOL). When the inclusion/exclusion criteria are met, on the day of the surgery the anesthetist in the operating room will choose one envelope to apply the designed protocol for each group. Data obtained at the clinical follow-up will be gathered by informed nurses at the ICU. All evaluations at the surgical wards especially for delirium and cognitive dysfunction will be evaluated by the same independent anesthetist who is blind to the study groups.
All patients will receive standard analgesia protocol as 1 gr paracetamol (maximum dose 4x1 and minimum dose interval as 6 hours) and rescue analgesia as 1mg/kg tramadol (maximum dose 4x1 and minimum dose interval as 6 hours). Moreover, if analgesia is not ensured 0,05 mg/kg morphine (IV) bolus doses are planned when their pain scales or NOL values are high (NRS >4; CPOT>2; NOL >25 over 1 minute). NRS and CPOT will be used as pain scales at postoperative 6th, 8th, 12th, and 24th hours for all patients. The Group Standard will be followed with standard monitorization only along with pain scales and receive rescue analgesia according to them. However, Group NOL will acquire NOL monitorization throughout the ICU stay and have the same rescue analgesia under NOL guidance with concurrent pain scales. The total amount of analgesics used during the ICU stay will be noted. Delirium and cognitive dysfunction will be evaluated at the 24th hour before discharge by CAM-ICU score and by 4AT at the surgical ward on the postoperative 3rd day before hospital discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Group A will be followed with standard monitorization only along with pain scales and receive rescue analgesia according to them. However, Group B will acquire NOL monitorization throughout the ICU stay and have the same rescue analgesia under NOL guidance with concurrent pain scales.
| Arm | Type | Receives |
|---|---|---|
| Group Standart of care | No intervention | –Patients will be followed with standard monitorization only along with pain scales and receive rescue analgesia according to them |
| Group Nociception level index monitor | Experimental | Device: nociception level index monitorPatients will acquire NOL monitorization throughout the ICU stay and have the same rescue analgesia under NOL guidance with concurrent pain scales |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) Physical Status classification I to III
- Patients who have been admitted to the postoperative intensive care unit
- Patients necessitating general anesthesia for surgery of more than 2 hours
- Patients who need mechanical ventilation for a while in intensive care follow-up
Key exclusion criteria (11 listed)
- Patients with additional organ failure
- Disease that may make it difficult to wean from the ventilator when lung functions are evaluated (Pao2/fio2 value below 200)
- History of allergies to drugs used in the study protocol
- Patients receiving deep anesthesia with sedation infusion RASS -2 (unable to be awakened by uncooperative audible stimulus)
- Patients with head trauma expected to have a low postoperative Glasgow coma score
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 |
|---|---|---|
| nociception level index monitorThe nociception level index (NOL) is one of the new electrophysiological devices to asses pain-related nociception and differs with its multi-parameter evaluation. It is generated from five different parameters (heart rate, heart rate variability, skin conductance level, photo-plethysmography waveform amplitude, number of skin conductance fluctuations, and their time derivatives) | Device | Group Nociception level index monitor |
Primary outcome
critical care observation pain tool
Time frame: postoperative 24 hour
critical care observation pain tool (CPOT) behavioral pain assessment score over 2 is accepted as pain to apply analgesia
number rating scale(NRS)
Time frame: postoperative 24 hour
number rating scale(NRS) value over 4 is accepted as pain to apply analgesia
3 secondary outcomes
The total amount of analgesic drug
Time frame: postoperative 24 hour
Delirium
Time frame: postoperative 24th hour
cognitive dysfunction
Time frame: postoperative 24th hour and postoperative 3th day
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 10 Jul 2023.
- Background: PubMed 34908872Gelinas C, Shahiri T S, Richard-Lalonde M, Laporta D, Morin JF, Boitor M, Ferland CE, Bourgault P, Richebe P. Exploration of a Multi-Parameter Technology for Pain Assessment in Postoperative Patients After Cardiac Surgery in the Intensive Care Unit: The Nociception Level Index (NOL)TM. J Pain Res. 2021 Dec 7;14:3723-3731. doi: 10.2147/JPR.S332845. eCollection 2021.
- Results publication: PubMed 35904563Chanques G, Gelinas C. Monitoring pain in the intensive care unit (ICU). Intensive Care Med. 2022 Oct;48(10):1508-1511. doi: 10.1007/s00134-022-06807-w. Epub 2022 Jul 29. No abstract available.
- Results publication: PubMed 35790979Kotfis K, van Diem-Zaal I, Williams Roberson S, Sietnicki M, van den Boogaard M, Shehabi Y, Ely EW. The future of intensive care: delirium should no longer be an issue. Crit Care. 2022 Jul 5;26(1):200. doi: 10.1186/s13054-022-04077-y.
- 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.
Berna Caliskan, MD principal investigator
Haseki Training and Research Hospital Anesthesiology and Reanimation Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nociception level index monitor in people with Intensive Care, Surgical and Anesthesia, General, run by Haseki 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 4 inclusion and 11 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 10 Jul 2023. 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?
critical care observation pain tool (time frame: postoperative 24 hour). 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?
On the ClinicalTrials.gov record for NCT05762666, 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 10 Jul 2023.