PainNCT05672212
Goal-directed Analgesia Using ANI During General Anesthesia in Children With Moyamoya Disease
A study testing ANI (Analgesia/Nociception Index) monitoring, standard monitoring and Sufentanil in people with Pain, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Analgesia Nociception Index (ANI) has been proposed for the evaluation of the nociception-antinociception balance in the perioperative period. In pediatric patients with Moyamoay disease, where the management of analgesia may be rendered difficult by pharmacological changes, we hypothesised that the monitoring of… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pain
- What is being tested?
- ANI (Analgesia/Nociception Index) monitoring, standard monitoring and Sufentanil
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Jan 2023to 4 Jan 2025
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients receiving EDAS surgery for Moyamoya disease
Who cannot join
- ASA (American society of anesthsiologists classification) 4-5
- Emergency surgery
- patients with chronic pain on medication
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul national university hospital
Seoul
Eun-hee Kim
About this study
Official title: Effect of Goal-directed Analgesia Using ANI (Analgesia/Nociception Index) During General Anesthesia in Children Undergoing EDAS (Encephaloduroarteriosynangiosis) Surgery for Moyamoya Disease: a Randomized Controlled Trial
Analgesia Nociception Index (ANI) has been proposed for the evaluation of the nociception-antinociception balance in the perioperative period. In pediatric patients with Moyamoay disease, where the management of analgesia may be rendered difficult by pharmacological changes, we hypothesised that the monitoring of analgesia with ANI would reduce intraoperative opioid consumption during EDAS surgery.
- Conditions
- Pain
- Being tested
- ANI (Analgesia/Nociception Index) monitoring, standard monitoring, Sufentanil
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANI (Analgesia/Nociception Index) monitoringDevice
Intraoperative analgesia was provided by injection of sufentanil, which was performed according to ANI monitor.
standard monitoringDevice
Intraoperative analgesia was provided by injection of sufentanil, which was performed according to the clinician's assessment.
SufentanilDrug
Sufentanil
| Study group | Role | What they receive |
|---|---|---|
| ANI (Analgesia/Nociception Index) monitoring | Experimental | Not described Receives: Device: ANI (Analgesia/Nociception Index) monitoring; Drug: Sufentanil |
| Standard monitoring | Active comparator | Not described Receives: Device: standard monitoring; Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
the mean hourly intraoperative sufentanil requirement
Measured: from induction of anesthesia to end of operation, about 5 hours
Secondary outcomes (2)
the amount of non-opioids analgesic requirements
Measured: from induction of anesthesia to end of operation, about 5 hours
the amount of vasoactive agents requirements
Measured: from induction of anesthesia to end of operation, about 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start4 Jan 2023
- Primary completion4 Jan 2025 (estimated)
- Study completion4 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun-hee Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672212
- Sponsor's protocol ID
- 2211-149-1381
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2023
- Last updated
- 9 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Park JB, Kang P, Ji SH, Jang YE, Lee JH, Kim JT, Kim HS, Kim EH. Effects of goal-directed analgesia using the analgesia nociception index in children undergoing surgery for moyamoya disease: A randomised controlled trial. Eur J Anaesthesiol. 2024 Sep 1;41(9):649-656. doi: 10.1097/EJA.0000000000002013. Epub 2024 Jun 3.
PubMed 38832435
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Goal-directed Analgesia Using ANI (Analgesia/Nociception Index) During General Anesthesia in Children Undergoing EDAS (Encephaloduroarteriosynangiosis) Surgery for Moyamoya Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05672212
- Acronym / sponsor ID
- 2211-149-1381
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 4 Jan 2025 (estimated)
- Study completion
- 4 Jan 2025 (estimated)
- First posted
- 5 Jan 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.
Analgesia Nociception Index (ANI) has been proposed for the evaluation of the nociception-antinociception balance in the perioperative period. In pediatric patients with Moyamoay disease, where the management of analgesia may be rendered difficult by pharmacological changes, we hypothesised that the monitoring of analgesia with ANI would reduce intraoperative opioid consumption during EDAS surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANI (Analgesia/Nociception Index) monitoring | Experimental | Device: ANI (Analgesia/Nociception Index) monitoring, Drug: Sufentanil |
| Standard monitoring | Active comparator | Device: standard monitoring, Drug: Sufentanil |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric patients receiving EDAS surgery for Moyamoya disease
Key exclusion criteria (3 listed)
- ASA (American society of anesthsiologists classification) 4-5
- Emergency surgery
- patients with chronic pain on medication
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 |
|---|---|---|
| ANI (Analgesia/Nociception Index) monitoringIntraoperative analgesia was provided by injection of sufentanil, which was performed according to ANI monitor. | Device | ANI (Analgesia/Nociception Index) monitoring |
| standard monitoringIntraoperative analgesia was provided by injection of sufentanil, which was performed according to the clinician's assessment. | Device | Standard monitoring |
| SufentanilSufentanil | Drug | ANI (Analgesia/Nociception Index) monitoring, Standard monitoring |
Primary outcome
the mean hourly intraoperative sufentanil requirement
Time frame: from induction of anesthesia to end of operation, about 5 hours
2 secondary outcomes
the amount of non-opioids analgesic requirements
Time frame: from induction of anesthesia to end of operation, about 5 hours
the amount of vasoactive agents requirements
Time frame: from induction of anesthesia to end of operation, about 5 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Derived from this study: PubMed 38832435Park JB, Kang P, Ji SH, Jang YE, Lee JH, Kim JT, Kim HS, Kim EH. Effects of goal-directed analgesia using the analgesia nociception index in children undergoing surgery for moyamoya disease: A randomised controlled trial. Eur J Anaesthesiol. 2024 Sep 1;41(9):649-656. doi: 10.1097/EJA.0000000000002013. Epub 2024 Jun 3.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANI (Analgesia/Nociception Index) monitoring, standard monitoring and Sufentanil in people with Pain, run by Seoul National University Hospital at 1 site in South Korea.
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 3 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 9 Jan 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 South Korea. 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 Eun-hee Kim (+82-2-2072-3664, beloveun@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the mean hourly intraoperative sufentanil requirement (time frame: from induction of anesthesia to end of operation, about 5 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 NCT05672212, which also lists 1 linked publication.
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 9 Jan 2023.