Opioid UsePURFTNCT03749811
Pupillometry-guided Remifentanil Infusion Versus Conventional Administration in Children
A study testing Pupillometry in people with Opioid Use, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Our study aims to compare the total intravenous dose of remifentanil per anesthesia hour and body weight in two groups of pediatric surgical patients - an interventional group with remifentanil infusion under pupillometry monitoring, and control group without pupillometry - to figure out whether pupillometry… Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Opioid Use
- What is being tested?
- Pupillometry
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Dec 2018to 18 Nov 2021
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients who are at 3 to 6 years of age, scheduled to undergo elective surgery with estimated time of operation 2 hours or longer, under general anesthesia
- American Society of Anesthesiologists physical status classification (ASA class) I - II
- Patient and his/her parents are willing to participate after explanation of the purpose, materials, methods, possible risks and benefits of the research
Who cannot join
- History of hypersensitivity/allergic reaction to the drugs which are used in general anesthesia
- Preoperative use of analgesics, antipsychotics and/or antiepileptics
- Mental retardation
- Medications related to hindrance of autonomic nerve system activity, e. g., beta blockers
- Underlying ophthalmic diseases
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Heesoo Kim
About this study
Official title: Comparison of Remifentanil Consumption in Pupillometry-guided Versus Conventional Administration in Pediatric Surgery: a Prospective, Randomized Controlled Trial
Our study aims to compare the total intravenous dose of remifentanil per anesthesia hour and body weight in two groups of pediatric surgical patients - an interventional group with remifentanil infusion under pupillometry monitoring, and control group without pupillometry - to figure out whether pupillometry monitoring may reduce remifentanil consumption during anesthesia while providing sufficient analgesia for surgical noxious stimuli.
Read the detailed description
comparison of total used opioid
- Conditions
- Opioid Use
- Being tested
- Pupillometry
- Keywords
- Pupil dilatory reflex, Remifentanil, Analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PupillometryDevice
After induction of anesthesia and determination of the loss of consciousness of the participant, baseline diameter of pupil is measured by electronic pupillometry device. During anesthesia, participant's pupil diameter is repeatedly measured with 5-minute interval. Pupil dilation of 30% or more compared to baseline is indicative of insufficient analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Pupillometry group | Experimental | A group of participants who receive remifentanil infusion under pupillometry monitoring. Receives: Device: Pupillometry |
| Conventional group | No intervention | A group of participants who receive remifentanil infusion without pupillometry monitoring; their analgesic dose is mainly determined via hemodyamic change. |
What is being measured
The primary outcome is the main question the study is designed to answer.
remifentanil total dose in microgram
Remifentanil total dose divided by anesthesia time (minute) and patient weight (kg).
Measured: from beginning of anesthesia to the end of the anesthesia
FLACC score
FLACC score (a pain evaluation method for children who cannot express their severity of pain verbally) right after post-anesthesia care unit arrival.
Measured: Arrival at the post-anesthesia care unit
Adjusted analgesic dose after anesthesia
Total dose of analgesics (NSAIDs and opioids) delivered to the patient since the end of the anesthesia, until 24 hours after the end of anesthesia
Measured: 24 hours after the end of anesthesia
Secondary outcomes (2)
Emergence time
Time between the end of the surgery and extubation
Measured: Intraoperative
Incidence of rescue therapy
Incidence of vasopressor/inotropics/anticholinergics/fluid/vasodilators administered, due to moderate to severe hemodynamic change
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start4 Dec 2018
- Primary completion18 Nov 2020 (estimated)
- Study completion18 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Interventional group: remifentanil infusion under pupillometry monitoring. Control group: remifentanil infusion without pupillometry monitoring (remifentanil dose is determined by conventional method, i. e., hemodynamic change probably related to noxious stimuli)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
- Investigators
- Hee-Soo Kim, M.D., Ph.D., Principal investigator, Dept. of Anesthesiology and Pain Medicine, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749811
- Sponsor's protocol ID
- 1811-036-984
- Acronym
- PURFT
- Status last verified
- Mar 2019
- First submitted
- 18 Nov 2018
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wildemeersch D, Peeters N, Saldien V, Vercauteren M, Hans G. Pain assessment by pupil dilation reflex in response to noxious stimulation in anaesthetized adults. Acta Anaesthesiol Scand. 2018 Sep;62(8):1050-1056. doi: 10.1111/aas.13129. Epub 2018 Apr 19.
PubMed 29671874Sabourdin N, Barrois J, Louvet N, Rigouzzo A, Guye ML, Dadure C, Constant I. Pupillometry-guided Intraoperative Remifentanil Administration versus Standard Practice Influences Opioid Use: A Randomized Study. Anesthesiology. 2017 Aug;127(2):284-292. doi: 10.1097/ALN.0000000000001705.
PubMed 28719527
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Remifentanil Consumption in Pupillometry-guided Versus Conventional Administration in Pediatric Surgery: a Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03749811
- Acronym / sponsor ID
- PURFT / 1811-036-984
- Conditions
- Opioid Use
- Keywords
- Pupil dilatory reflex, Remifentanil, Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 18 Nov 2020 (estimated)
- Study completion
- 18 Nov 2021 (estimated)
- First posted
- 21 Nov 2018 (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.
Our study aims to compare the total intravenous dose of remifentanil per anesthesia hour and body weight in two groups of pediatric surgical patients - an interventional group with remifentanil infusion under pupillometry monitoring, and control group without pupillometry - to figure out whether pupillometry monitoring may reduce remifentanil consumption during anesthesia while providing sufficient analgesia for surgical noxious stimuli.
Detailed description
comparison of total used opioid
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional group: remifentanil infusion under pupillometry monitoring. Control group: remifentanil infusion without pupillometry monitoring (remifentanil dose is determined by conventional method, i. e., hemodynamic change probably related to noxious stimuli)
| Arm | Type | Receives |
|---|---|---|
| Pupillometry group | Experimental | Device: PupillometryA group of participants who receive remifentanil infusion under pupillometry monitoring. |
| Conventional group | No intervention | –A group of participants who receive remifentanil infusion without pupillometry monitoring; their analgesic dose is mainly determined via hemodyamic change. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients who are at 3 to 6 years of age, scheduled to undergo elective surgery with estimated time of operation 2 hours or longer, under general anesthesia
- American Society of Anesthesiologists physical status classification (ASA class) I - II
- Patient and his/her parents are willing to participate after explanation of the purpose, materials, methods, possible risks and benefits of the research
Key exclusion criteria (5 listed)
- History of hypersensitivity/allergic reaction to the drugs which are used in general anesthesia
- Preoperative use of analgesics, antipsychotics and/or antiepileptics
- Mental retardation
- Medications related to hindrance of autonomic nerve system activity, e. g., beta blockers
- Underlying ophthalmic 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 |
|---|---|---|
| PupillometryAfter induction of anesthesia and determination of the loss of consciousness of the participant, baseline diameter of pupil is measured by electronic pupillometry device. During anesthesia, participant's pupil diameter is repeatedly measured with 5-minute interval. Pupil dilation of 30% or more compared to baseline is indicative of insufficient analgesia. | Device | Pupillometry group |
Primary outcome
remifentanil total dose in microgram
Time frame: from beginning of anesthesia to the end of the anesthesia
Remifentanil total dose divided by anesthesia time (minute) and patient weight (kg).
FLACC score
Time frame: Arrival at the post-anesthesia care unit
FLACC score (a pain evaluation method for children who cannot express their severity of pain verbally) right after post-anesthesia care unit arrival.
Adjusted analgesic dose after anesthesia
Time frame: 24 hours after the end of anesthesia
Total dose of analgesics (NSAIDs and opioids) delivered to the patient since the end of the anesthesia, until 24 hours after the end of anesthesia
2 secondary outcomes
Emergence time
Time frame: Intraoperative
Incidence of rescue therapy
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Results publication: PubMed 29671874Wildemeersch D, Peeters N, Saldien V, Vercauteren M, Hans G. Pain assessment by pupil dilation reflex in response to noxious stimulation in anaesthetized adults. Acta Anaesthesiol Scand. 2018 Sep;62(8):1050-1056. doi: 10.1111/aas.13129. Epub 2018 Apr 19.
- Results publication: PubMed 28719527Sabourdin N, Barrois J, Louvet N, Rigouzzo A, Guye ML, Dadure C, Constant I. Pupillometry-guided Intraoperative Remifentanil Administration versus Standard Practice Influences Opioid Use: A Randomized Study. Anesthesiology. 2017 Aug;127(2):284-292. doi: 10.1097/ALN.0000000000001705.
- 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.
Hee-Soo Kim, M.D., Ph.D. principal investigator
Dept. of Anesthesiology and Pain Medicine, Seoul National University 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 Pupillometry in people with Opioid Use, 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 3 inclusion and 5 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 29 Mar 2019. 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 Hee-Soo Kim, M.D., Ph.D. (+82-2-2072-3664, dami0605@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
remifentanil total dose in microgram (time frame: from beginning of anesthesia to the end of the anesthesia). The study lists 3 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 NCT03749811, which also lists 2 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 29 Mar 2019.