AnalgesiaNCT04319913
ANI-guided Intraoperative Analgesia in Low-pressure Anesthesia
A study testing analgesia nociception index in people with Analgesia and Functional Endoscopic Sinus Surgery, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
During functional endoscopic sinus surgery(FESS), low-pressure anesthesia is often applied, aiming to decreased operative blood loss, and anesthetics, narcotics and antihypertensive agents are given to achieve desirable low blood pressure. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Analgesia, Functional Endoscopic Sinus Surgery, Heart Rate Variability
- What is being tested?
- analgesia nociception index
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2020to 31 Dec 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status class I or II
- age between 20-65
- body mass index less than 35
- scheduled for functional endoscopic sinus surgery
Who cannot join
- major cardiovascular disease, arrhythmia, respiratory disease, cerebral vascular disease, or ASA physical status classification III or greater
- documented or self-reported history of chronic pain
- acute or chronic opioid analgesic use
- dysautonomia
- diabetes mellitus with evidence of neuropathy
- emergency cases
- allergy to medications in the study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
MacKay Memorial Hospital
Taipei, 104
Chien-Chung Huang, MD, +886225433535 ext. 3009, cchuang@dr.com
About this study
Official title: Whether Intraoperative Analgesia Guided by the Analgesia Nociception Index (ANI) Can Decrease the Amount of Narcotics, Other Anesthetic Drugs, and Blood Loss in Patients Undergoing Low-pressure Anesthesia: a Randomized Controlled Trial
During functional endoscopic sinus surgery(FESS), low-pressure anesthesia is often applied, aiming to decreased operative blood loss, and anesthetics, narcotics and antihypertensive agents are given to achieve desirable low blood pressure. However, the dose of these medications given is usually decided subjectively based on the clinical experience of the care provider, placing the patient in a risky situation of narcotics overdosing or underdosing. Therefore, here is the question: Whether intraoperative analgesia guided by an objective pain monitoring device, such as the Analgesia Nociception Index (ANI), could decrease the amount of narcotics, other anesthetic agents, and blood loss in patients undergoing low-pressure anesthesia.
Read the detailed description
Analgesia nociception index (ANI) is an objective pain monitoring device, it could measure parasympathetic tone base on heart rate variability analysis, which is a way to measure the effect of respiratory sinus arrhythmia on heart rate. In the previous studies, ANI had been used to predict immediate postoperative pain, intraoperative analgesia in children, and intraoperative analgesia in bariatric surgery, which showed ANI can be used to detect surgical stimuli, reduce intraoperative consumption of narcotics, and assess immediate postoperative pain intensity. However, no publication has mentioned ANI been used in low-pressure anesthesia.
Participants with ASA physical status class I or II, age between 20-65, and body mass index less than 35 who would undergo FESS are enrolled and randomly allocated by using computer-generated random number table into two groups with equal probability: ANI-guided remifentanil titration or remifentanil titration by standard care. Total intravenous anesthesia with propofol TCI(target controlled infusion) and remifentanil TCI are used for anesthesia maintenance, targeting bispectral index between 40 and 60. The ANI value in experimental group would be maintained between 50 and 70. Intraoperative mean arterial pressure (MAP) would be targeted at 55-65 mmHg, and calcium channel blocker would be administered if MAP could not achieve target despite of propofol and remifentanil titration.
Participant's demographics, baseline information, type and duration of the operation, duration from end of the surgery till participant awaken, ANI value, vital signs, the amount of narcotics, anesthetics and antihypertensive medications used, intraoperative blood loss, surgeon's satisfaction to the operation field, participant first recorded pain score in postoperative recovery room using visual analogue scale, and opioid-associated side effects such as nausea, vomiting, pruritis, dizziness in postoperative recovery room, will be recorded and analyzed. The statisticians will apply Chi-square for categorical data, T-test for continuous data, and multiple regressions analysis. P value less than 0.05 was considered statistically significant. Using G-power software to estimate, predicted sample size is 120 presuming type I error 0.05, power 0.95, and medium effect size.
- Conditions
- Analgesia, Functional Endoscopic Sinus Surgery, Heart Rate Variability, Opioid Consumption
- Being tested
- analgesia nociception index
- Keywords
- analgesia nociception index, functional endoscopic sinus surgery, analgesia, opioid consumption, heart rate variability, low pressure anesthesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analgesia nociception indexDevice
Analgesia nociception index (ANI) could objectively monitor how pain the participant is. In the experimental group, the care provider would decrease the dose of narcotics (remifentanil) if the ANI value is above 70, and increase the dose if the ANI value is under 50.
| Study group | Role | What they receive |
|---|---|---|
| ANI-guided | Experimental | ANI-guided narcotics use to maintain ANI value between 50 to 70 Receives: Device: analgesia nociception index |
| Control | No intervention | narcotics use guided by clinical experience, ANI is still recorded but would be covered up intraoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narcotics consumption
Remifentanil would be used as narcotics, the total amount used intraoperatively would be recorded
Measured: From the first given dose of remifentanil until the last given given dose of remifentanil during anesthesia, assessed up to 8 hours.
Secondary outcomes (1)
Anesthetics consumption
The amount of anesthetics (mainly propofol) used intraoperatively would be recorded
Measured: From the first given dose of anesthetics (propofol or midazolam, whichever comes first) until the last given given dose of anesthetics (propofol or midazolam, whichever comes last), assessed up to 8 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start1 Jul 2020
- Primary completion30 Dec 2023 (estimated)
- Study completion31 Dec 2023 (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 AnalgesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chien-Chung,Huang, Mackay Memorial Hospital
- Investigators
- Chien-Chung Huang, MD, Study director, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319913
- Sponsor's protocol ID
- 20MMHIS069e
- Status last verified
- Mar 2023
- First submitted
- 20 Mar 2020
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boselli E, Bouvet L, Begou G, Dabouz R, Davidson J, Deloste JY, Rahali N, Zadam A, Allaouchiche B. Prediction of immediate postoperative pain using the analgesia/nociception index: a prospective observational study. Br J Anaesth. 2014 Apr;112(4):715-21. doi: 10.1093/bja/aet407. Epub 2013 Dec 8.
PubMed 24322571Julien-Marsollier F, Rachdi K, Caballero MJ, Ayanmanesh F, Vacher T, Horlin AL, Skhiri A, Brasher C, Michelet D, Dahmani S. Evaluation of the analgesia nociception index for monitoring intraoperative analgesia in children. Br J Anaesth. 2018 Aug;121(2):462-468. doi: 10.1016/j.bja.2018.03.034. Epub 2018 Jun 5.
PubMed 30032886Le Gall L, David A, Carles P, Leuillet S, Chastel B, Fleureau C, Dewitte A, Ouattara A. Benefits of intraoperative analgesia guided by the Analgesia Nociception Index (ANI) in bariatric surgery: An unmatched case-control study. Anaesth Crit Care Pain Med. 2019 Feb;38(1):35-39. doi: 10.1016/j.accpm.2017.09.004. Epub 2017 Oct 12.
PubMed 29033356
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whether Intraoperative Analgesia Guided by the Analgesia Nociception Index (ANI) Can Decrease the Amount of Narcotics, Other Anesthetic Drugs, and Blood Loss in Patients Undergoing Low-pressure Anesthesia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04319913
- Acronym / sponsor ID
- 20MMHIS069e
- Conditions
- Analgesia, Functional Endoscopic Sinus Surgery, Heart Rate Variability, Opioid Consumption
- Keywords
- analgesia nociception index, functional endoscopic sinus surgery, analgesia, opioid consumption, heart rate variability, low pressure anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Mar 2020 (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.
During functional endoscopic sinus surgery(FESS), low-pressure anesthesia is often applied, aiming to decreased operative blood loss, and anesthetics, narcotics and antihypertensive agents are given to achieve desirable low blood pressure. However, the dose of these medications given is usually decided subjectively based on the clinical experience of the care provider, placing the patient in a risky situation of narcotics overdosing or underdosing. Therefore, here is the question: Whether intraoperative analgesia guided by an objective pain monitoring device, such as the Analgesia Nociception Index (ANI), could decrease the amount of narcotics, other anesthetic agents, and blood loss in patients undergoing low-pressure anesthesia.
Detailed description
Analgesia nociception index (ANI) is an objective pain monitoring device, it could measure parasympathetic tone base on heart rate variability analysis, which is a way to measure the effect of respiratory sinus arrhythmia on heart rate. In the previous studies, ANI had been used to predict immediate postoperative pain, intraoperative analgesia in children, and intraoperative analgesia in bariatric surgery, which showed ANI can be used to detect surgical stimuli, reduce intraoperative consumption of narcotics, and assess immediate postoperative pain intensity. However, no publication has mentioned ANI been used in low-pressure anesthesia.
Participants with ASA physical status class I or II, age between 20-65, and body mass index less than 35 who would undergo FESS are enrolled and randomly allocated by using computer-generated random number table into two groups with equal probability: ANI-guided remifentanil titration or remifentanil titration by standard care. Total intravenous anesthesia with propofol TCI(target controlled infusion) and remifentanil TCI are used for anesthesia maintenance, targeting bispectral index between 40 and 60. The ANI value in experimental group would be maintained between 50 and 70. Intraoperative mean arterial pressure (MAP) would be targeted at 55-65 mmHg, and calcium channel blocker would be administered if MAP could not achieve target despite of propofol and remifentanil titration.
Participant's demographics, baseline information, type and duration of the operation, duration from end of the surgery till participant awaken, ANI value, vital signs, the amount of narcotics, anesthetics and antihypertensive medications used, intraoperative blood loss, surgeon's satisfaction to the operation field, participant first recorded pain score in postoperative recovery room using visual analogue scale, and opioid-associated side effects such as nausea, vomiting, pruritis, dizziness in postoperative recovery room, will be recorded and analyzed. The statisticians will apply Chi-square for categorical data, T-test for continuous data, and multiple regressions analysis. P value less than 0.05 was considered statistically significant. Using G-power software to estimate, predicted sample size is 120 presuming type I error 0.05, power 0.95, and medium effect size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANI-guided | Experimental | Device: analgesia nociception indexANI-guided narcotics use to maintain ANI value between 50 to 70 |
| Control | No intervention | –narcotics use guided by clinical experience, ANI is still recorded but would be covered up intraoperatively |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA physical status class I or II
- age between 20-65
- body mass index less than 35
- scheduled for functional endoscopic sinus surgery
Key exclusion criteria (7 listed)
- major cardiovascular disease, arrhythmia, respiratory disease, cerebral vascular disease, or ASA physical status classification III or greater
- documented or self-reported history of chronic pain
- acute or chronic opioid analgesic use
- dysautonomia
- diabetes mellitus with evidence of neuropathy
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 indexAnalgesia nociception index (ANI) could objectively monitor how pain the participant is. In the experimental group, the care provider would decrease the dose of narcotics (remifentanil) if the ANI value is above 70, and increase the dose if the ANI value is under 50. | Device | ANI-guided |
Primary outcome
Narcotics consumption
Time frame: From the first given dose of remifentanil until the last given given dose of remifentanil during anesthesia, assessed up to 8 hours.
Remifentanil would be used as narcotics, the total amount used intraoperatively would be recorded
1 secondary outcome
Anesthetics consumption
Time frame: From the first given dose of anesthetics (propofol or midazolam, whichever comes first) until the last given given dose of anesthetics (propofol or midazolam, whichever comes last), assessed up to 8 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Background: PubMed 24322571Boselli E, Bouvet L, Begou G, Dabouz R, Davidson J, Deloste JY, Rahali N, Zadam A, Allaouchiche B. Prediction of immediate postoperative pain using the analgesia/nociception index: a prospective observational study. Br J Anaesth. 2014 Apr;112(4):715-21. doi: 10.1093/bja/aet407. Epub 2013 Dec 8.
- Background: PubMed 30032886Julien-Marsollier F, Rachdi K, Caballero MJ, Ayanmanesh F, Vacher T, Horlin AL, Skhiri A, Brasher C, Michelet D, Dahmani S. Evaluation of the analgesia nociception index for monitoring intraoperative analgesia in children. Br J Anaesth. 2018 Aug;121(2):462-468. doi: 10.1016/j.bja.2018.03.034. Epub 2018 Jun 5.
- Background: PubMed 29033356Le Gall L, David A, Carles P, Leuillet S, Chastel B, Fleureau C, Dewitte A, Ouattara A. Benefits of intraoperative analgesia guided by the Analgesia Nociception Index (ANI) in bariatric surgery: An unmatched case-control study. Anaesth Crit Care Pain Med. 2019 Feb;38(1):35-39. doi: 10.1016/j.accpm.2017.09.004. Epub 2017 Oct 12.
- 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.
Chien-Chung Huang, MD study director
Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing analgesia nociception index in people with Analgesia and Functional Endoscopic Sinus Surgery, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 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: status not confirmed, as of the sponsor's last update on 15 Mar 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chien-Chung Huang, MD (+886225433535 ext. 3009, cchuang@dr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Narcotics consumption (time frame: From the first given dose of remifentanil until the last given given dose of remifentanil during anesthesia, assessed up to 8 hours.). 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 NCT04319913, 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 15 Mar 2023.