Pain, PostoperativeANINCT06752824
Analgesia Nociception Index (ANI) in Intracranial Surgical Anesthesia
An observational study of Pain, Postoperative and Analgesia, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
In our study, 75 patients aged 18-80 years, classified as ASA I-II risk groups, who underwent intracranial surgery performed by the Department of Neurosurgery at Trakya University Faculty of Medicine Hospital, were included. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative, Analgesia, Supratentorial Brain Tumor
- What is being tested?
- ANALGESIA NOCICEPTION INDEX MONITORING
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Jan 2024
- How long will I take part?
- 1 Day
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Seventy-five patients in ASA I-II risk group aged 18-80 who will undergo intracranial surgery by Brain and Nerve Surgery at Trakya University Faculty of Medicine Hospital will be included in the study.
Who may be able to join
- ASA I-II patients
- Patients between the ages of 18-80
- patients undergoing intracranial surgery
Who cannot join
- major comorbid diseases,
- patients using beta adrenergic blockers, clonidine,
- patients with pacemakers or significant arrhythmias (e.g. atrial fibrillation),
- patients using medications that affect sinus rhythm (atropine, ephedrine, glycopyrrolate),
- patients with chronic pain and cerebrovascular diseases,
- patients who will undergo planned postoperative ventilation,
- patients with chronic pain due to opioid medications, and patients with opioid addiction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trakya Üniversitesi Tip Fakültesi
Edirne, Merkez, 22100
About this study
Official title: Evaluation of Analgesia Nociception Index Monitoring in Intracranial Surgery Anesthesia
In our study, 75 patients aged 18-80 years, classified as ASA I-II risk groups, who underwent intracranial surgery performed by the Department of Neurosurgery at Trakya University Faculty of Medicine Hospital, were included. After the patients were positioned on the neurosurgical operating table, heart rate, systolic blood pressure, diastolic blood pressure, peripheral oxygen saturation, and entropy values were measured in all cases. Baseline values were recorded for patients who underwent ANI (Analgesia Nociception Index) monitoring. In both groups, entropy values were targeted to remain within the range of 40-60. In the ANI group, ANI values were maintained between 50-70.
Patients were divided into two groups based on the intraoperative monitoring method applied: the ANI group (n=38) and the control group (n=37). All patients underwent entropy monitoring, while ANI monitoring was exclusively used in the ANI group for pain management. In the ANI group, remifentanil infusion adjustments were made to keep ANI values within the 50-70 range.
This study aimed to compare perioperative opioid consumption, postoperative pain, and recovery from anesthesia in patients undergoing intracranial surgery who received general anesthesia and analgesia management guided by either entropy monitoring alone or a combination of entropy and ANI monitoring.
Read the detailed description
In this study, we aimed to compare perioperative opioid consumption, postoperative pain, and recovery from anesthesia in patients undergoing intracranial surgery who were managed with general anesthesia and analgesia based on entropy monitoring or a combination of entropy and ANI monitoring during the intraoperative period.
A total of 75 patients aged between 18 and 80 years, classified as ASA I-II, who underwent intracranial surgery at Trakya University Medical Faculty Hospital between January 1, 2021, and January 1, 2024, were included in the study. Patients were divided into two groups based on the intraoperative monitoring techniques used: the ANI group (n=38) and the Control group (n=37). All patients underwent entropy monitoring during the operation. In the ANI group, ANI monitoring was additionally used for pain management.
The study recorded intraoperative data such as mean arterial pressure, heart rate, SpO2, end-tidal CO2, ANI, RE, SE values at baseline, induction, intubation, pin placement, skin incision, craniotomy, dura opening, bleeding control, pin removal, skin closure, and postoperatively. These values were measured at intervals of 5 minutes for the first 20 minutes, then every 10 minutes until 60 minutes, and every 30 minutes up to 180 minutes. Surgical type, anesthesia duration, the amount of erythrocyte suspension and fresh frozen plasma used based on intraoperative requirements, and anesthetic drugs (propofol, rocuronium, fentanyl) were recorded. The total remifentanil consumption was documented via the infusion pump.
Postoperative recovery in the recovery unit was evaluated using the Glasgow Coma Scale (GCS), the Ramsey Sedation Scale, and the duration with a Modified Aldrete Score (MAS) greater than 9. Pain was assessed using the Visual Analog Scale (VAS). VAS values were recorded at 1, 2, 4, 6, 12, and 24 hours. If VAS scores exceeded 4, intravenous paracetamol, tramadol, and meperidine were administered in stepwise treatment. The time to first analgesic use, postoperative analgesic consumption in the first 24 hours, and any postoperative complications were recorded.
Categorical variables were expressed as frequency distributions (number, percentage), and numerical variables were analyzed with descriptive statistics (mean, standard deviation). Differences between the two groups for categorical variables were examined using the independent samples t-test, Pearson correlation analysis was used to assess relationships between two numerical variables, and the Chi-square test was used to analyze relationships between two categorical variables. A p-value of <0.05 was considered statistically significant.
- Conditions
- Pain, Postoperative, Analgesia, Supratentorial Brain Tumor, Infratentorial Neoplasms, Pituitary Neoplasms, Intraoperative Monitoring
- Being tested
- ANALGESIA NOCICEPTION INDEX MONITORING
- Keywords
- INTRACRANIAL SURGERY, ENTROPY, ANI
- Medical subject headings
- Pain, Postoperative, Agnosia, Infratentorial Neoplasms, Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANALGESIA NOCICEPTION INDEX MONITORINGDevice
Also called ANI
INTRACRANIAL SURGERY
| Study group | Role | What they receive |
|---|---|---|
| ANI GROUP | ANI MONITORING Receives: Device: ANALGESIA NOCICEPTION INDEX MONITORING | |
| CONTROL GROUP | STANDARD MONITORING |
What is being measured
The primary outcome is the main question the study is designed to answer.
INTRAOPERATIVE OPIOID USE
Lower dose opioid use during surgery is associated with more favorable outcomes in terms of postoperative pain and recovery scores.
Measured: during the surgery/procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start1 Jan 2021
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Gunbay, Trakya University
- Investigators
- SEVTAP HEKİMOĞLU ŞAHİN, Study chair, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752824
- Sponsor's protocol ID
- TÜTF-BAEK 2020/406
- Acronym
- ANI
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Analgesia Nociception Index Monitoring in Intracranial Surgery Anesthesia
- ClinicalTrials.gov ID
- NCT06752824
- Acronym / sponsor ID
- ANI / TÜTF-BAEK 2020/406
- Conditions
- Pain, Postoperative, Analgesia, Supratentorial Brain Tumor, Infratentorial Neoplasms, Pituitary Neoplasms, Intraoperative Monitoring
- Keywords
- INTRACRANIAL SURGERY, ENTROPY, ANI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 31 Dec 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.
In our study, 75 patients aged 18-80 years, classified as ASA I-II risk groups, who underwent intracranial surgery performed by the Department of Neurosurgery at Trakya University Faculty of Medicine Hospital, were included. After the patients were positioned on the neurosurgical operating table, heart rate, systolic blood pressure, diastolic blood pressure, peripheral oxygen saturation, and entropy values were measured in all cases. Baseline values were recorded for patients who underwent ANI (Analgesia Nociception Index) monitoring. In both groups, entropy values were targeted to remain within the range of 40-60. In the ANI group, ANI values were maintained between 50-70.
Patients were divided into two groups based on the intraoperative monitoring method applied: the ANI group (n=38) and the control group (n=37). All patients underwent entropy monitoring, while ANI monitoring was exclusively used in the ANI group for pain management. In the ANI group, remifentanil infusion adjustments were made to keep ANI values within the 50-70 range.
This study aimed to compare perioperative opioid consumption, postoperative pain, and recovery from anesthesia in patients undergoing intracranial surgery who received general anesthesia and analgesia management guided by either entropy monitoring alone or a combination of entropy and ANI monitoring.
Detailed description
In this study, we aimed to compare perioperative opioid consumption, postoperative pain, and recovery from anesthesia in patients undergoing intracranial surgery who were managed with general anesthesia and analgesia based on entropy monitoring or a combination of entropy and ANI monitoring during the intraoperative period.
A total of 75 patients aged between 18 and 80 years, classified as ASA I-II, who underwent intracranial surgery at Trakya University Medical Faculty Hospital between January 1, 2021, and January 1, 2024, were included in the study. Patients were divided into two groups based on the intraoperative monitoring techniques used: the ANI group (n=38) and the Control group (n=37). All patients underwent entropy monitoring during the operation. In the ANI group, ANI monitoring was additionally used for pain management.
The study recorded intraoperative data such as mean arterial pressure, heart rate, SpO2, end-tidal CO2, ANI, RE, SE values at baseline, induction, intubation, pin placement, skin incision, craniotomy, dura opening, bleeding control, pin removal, skin closure, and postoperatively. These values were measured at intervals of 5 minutes for the first 20 minutes, then every 10 minutes until 60 minutes, and every 30 minutes up to 180 minutes. Surgical type, anesthesia duration, the amount of erythrocyte suspension and fresh frozen plasma used based on intraoperative requirements, and anesthetic drugs (propofol, rocuronium, fentanyl) were recorded. The total remifentanil consumption was documented via the infusion pump.
Postoperative recovery in the recovery unit was evaluated using the Glasgow Coma Scale (GCS), the Ramsey Sedation Scale, and the duration with a Modified Aldrete Score (MAS) greater than 9. Pain was assessed using the Visual Analog Scale (VAS). VAS values were recorded at 1, 2, 4, 6, 12, and 24 hours. If VAS scores exceeded 4, intravenous paracetamol, tramadol, and meperidine were administered in stepwise treatment. The time to first analgesic use, postoperative analgesic consumption in the first 24 hours, and any postoperative complications were recorded.
Categorical variables were expressed as frequency distributions (number, percentage), and numerical variables were analyzed with descriptive statistics (mean, standard deviation). Differences between the two groups for categorical variables were examined using the independent samples t-test, Pearson correlation analysis was used to assess relationships between two numerical variables, and the Chi-square test was used to analyze relationships between two categorical variables. A p-value of <0.05 was considered statistically significant.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANI GROUP | – | Device: ANALGESIA NOCICEPTION INDEX MONITORINGANI MONITORING |
| CONTROL GROUP | – | –STANDARD MONITORING |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Seventy-five patients in ASA I-II risk group aged 18-80 who will undergo intracranial surgery by Brain and Nerve Surgery at Trakya University Faculty of Medicine Hospital will be included in the study.
Key inclusion criteria (3 listed)
- ASA I-II patients
- Patients between the ages of 18-80
- patients undergoing intracranial surgery
Key exclusion criteria (7 listed)
- major comorbid diseases,
- patients using beta adrenergic blockers, clonidine,
- patients with pacemakers or significant arrhythmias (e.g. atrial fibrillation),
- patients using medications that affect sinus rhythm (atropine, ephedrine, glycopyrrolate),
- patients with chronic pain and cerebrovascular diseases,
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 |
|---|---|---|
| ANALGESIA NOCICEPTION INDEX MONITORINGAlso: ANIINTRACRANIAL SURGERY | Device | ANI GROUP |
Primary outcome
INTRAOPERATIVE OPIOID USE
Time frame: during the surgery/procedure
Lower dose opioid use during surgery is associated with more favorable outcomes in terms of postoperative pain and recovery scores.
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 31 Dec 2024.
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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.
SEVTAP HEKİMOĞLU ŞAHİN study chair
Trakya University
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, Postoperative and Analgesia, run by Trakya University 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 7 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 31 Dec 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?
INTRAOPERATIVE OPIOID USE (time frame: during the surgery/procedure). 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 31 Dec 2024.