Pain, AcuteNCT05049577
Preanesthetic Analgesia/Nociception Index (ANI) and Propofol Injection Pain
A study testing Analgesia/Nociception Index (ANI) in people with Pain, Acute and Analgesia, run by Wonkwang University Hospital at 1 site in South Korea.
Trial summary
Recently, Analgesia Nociception Index (ANI) has been evaluated for objectively measuring peri-operative pain and to guide intra-operative opioid administration during various surgeries. Propofol injection pain (PIP) is a common problem and can be very distressing to the patient. Read more about this study
- Who is it for?
- Ages 19 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Analgesia, Nociceptive Pain
- What is being tested?
- Analgesia/Nociception Index (ANI)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2023to 30 Jun 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 19 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male patients who scheduled for general anesthesia
- Cognitive patients who could understand this study
Who cannot join
- Patients receiving β-receptor blockers, ketamine, clonidine, or any vasoactive substance (i.e. metaraminol, ephedrine) and patients receiving neostigmine, atropine or glycopyrrolate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Preanesthetic Analgesia/Nociception Index (ANI) Predict Propofol Injection Pain
Recently, Analgesia Nociception Index (ANI) has been evaluated for objectively measuring peri-operative pain and to guide intra-operative opioid administration during various surgeries.
Propofol injection pain (PIP) is a common problem and can be very distressing to the patient.
Read the detailed description
This study aimed to the association of preanesthetic ANI scores and PIP in patients who scheduled for general anesthesia.
Before propofol administration in remifentanil group, preanesthetic ANI values (instant and mean) were checked after remifentanil to a target Ce of 4 ng/ml.
Control group received the same volume of saline as remifentanil group. Heart rate and bispectral index were checked as ANI. Point biserial correlation and ROC curve were analyzed.
- Conditions
- Pain, Acute, Analgesia, Nociceptive Pain
- Being tested
- Analgesia/Nociception Index (ANI)
- Medical subject headings
- Acute Pain, Agnosia, Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesia/Nociception Index (ANI)Device
Also called ANI MOC-9
V1 and V5 electrocardiographic positions as per the manufacturer's recommendations. The ANI was continuously recorded and displayed with a frequency of 1 Hz. ANI scores measured immediately before propofol administration, half-dose administration (1mg/kg), and full-dose administration (2mg/kg)of propofol.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | To maintain blinding, in the control group, the remifentanil infusion was replaced with 50 ml of normal saline in 50 ml syringe. The remifentanil (or saline) infusion was run until the pump indicated the target Ce had been achieved. Pharmacokinetic model for remifentanil was the Minto model (Height, Weight, and Age) Anesthesia in all patients was induced using 2 mg/kg of 2% propofol. The attending anesthesiologist asked the patients how they felt pain to evaluate pain severity of PIP while half -dose of propofol was administered. After the rest of the propofol was administered, the attending anesthesiologists asked the same question. Receives: Device: Analgesia/Nociception Index (ANI) |
| Remifentanil group | Experimental | Remifentanil 1 mg was diluted into 50 ml of normal saline. A commercial TCI pump (Orchestra Base Primea, Fresenius Vial, France) was used for the effect-site TCI of remifentanil. The study groups received remifentanil to a target Ce of 4 ng/ ml. Pharmacokinetic model for remifentanil was the Minto model (Height, Weight, and Age) Anesthesia induction and the evaluation of pain were same as control group Receives: Device: Analgesia/Nociception Index (ANI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation of Analgesia/nociception Index (ANI) and Propofol injection pain (PIP)
The correlation of preanesthetic ANI scores and incidence of PIP.
Measured: Immediately before administration of propofol (2mg/kg)
Secondary outcomes (2)
Incidence and severity of PIP
Incidence and severity with numeric rating scales( 0= no pain, 100=worst pain) of propofol injection pain
Measured: during anesthesia induction ( half-dose (1mg/kg) and full-dose of (2mg/kg) propofol administration)
The correlation of Analgesia/nociception Index (ANI) and Propofol injection pain (PIP)
The correlation of preanesthetic ANI scores and severity of PIP.
Measured: Immediately before administration of propofol (2mg/kg)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start1 Apr 2023
- Primary completion10 Apr 2023
- Study completion30 Jun 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 Pain, AcuteStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized and controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonkwang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheol Lee,MD,PhD,, Wonkwang University Hospital
- Investigators
- Cheol Lee, M.D,Ph.D, Principal investigator, Department of anesthesiology and pain medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049577
- Sponsor's protocol ID
- WonkwangUH8
- Status last verified
- Oct 2023
- First submitted
- 24 Aug 2021
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: if other researchers ask, a decision will be made after discussion with the co-authors
Publications
Chanques G, Tarri T, Ride A, Prades A, De Jong A, Carr J, Molinari N, Jaber S. Analgesia nociception index for the assessment of pain in critically ill patients: a diagnostic accuracy study. Br J Anaesth. 2017 Oct 1;119(4):812-820. doi: 10.1093/bja/aex210.
PubMed 29121287Ledowski T. Objective monitoring of nociception: a review of current commercial solutions. Br J Anaesth. 2019 Aug;123(2):e312-e321. doi: 10.1016/j.bja.2019.03.024. Epub 2019 Apr 30.
PubMed 31047645Abdullayev R, Yildirim E, Celik B, Topcu Sarica L. Analgesia Nociception Index: Heart Rate Variability Analysis of Emotional Status. Cureus. 2019 Apr 2;11(4):e4365. doi: 10.7759/cureus.4365.
PubMed 31192070
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Preanesthetic Analgesia/Nociception Index (ANI) Predict Propofol Injection Pain
- ClinicalTrials.gov ID
- NCT05049577
- Acronym / sponsor ID
- WonkwangUH8
- Conditions
- Pain, Acute, Analgesia, Nociceptive Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Wonkwang University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 20 Sep 2021 (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.
Recently, Analgesia Nociception Index (ANI) has been evaluated for objectively measuring peri-operative pain and to guide intra-operative opioid administration during various surgeries.
Propofol injection pain (PIP) is a common problem and can be very distressing to the patient.
Detailed description
This study aimed to the association of preanesthetic ANI scores and PIP in patients who scheduled for general anesthesia.
Before propofol administration in remifentanil group, preanesthetic ANI values (instant and mean) were checked after remifentanil to a target Ce of 4 ng/ml.
Control group received the same volume of saline as remifentanil group. Heart rate and bispectral index were checked as ANI. Point biserial correlation and ROC curve were analyzed.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized and controlled study
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Device: Analgesia/Nociception Index (ANI)To maintain blinding, in the control group, the remifentanil infusion was replaced with 50 ml of normal saline in 50 ml syringe. The remifentanil (or saline) infusion was run until the pump indicated the target Ce had been achieved. Pharmacokinetic model for remifentanil was the Minto model (Height, Weight, and Age) Anesthesia in all patients was induced using 2 mg/kg of 2% propofol. The attending anesthesiologist asked the patients how they felt pain to evaluate pain severity of PIP while half -dose of propofol was administered. After the rest of the propofol was administered, the attending anesthesiologists asked the same question. |
| Remifentanil group | Experimental | Device: Analgesia/Nociception Index (ANI)Remifentanil 1 mg was diluted into 50 ml of normal saline. A commercial TCI pump (Orchestra Base Primea, Fresenius Vial, France) was used for the effect-site TCI of remifentanil. The study groups received remifentanil to a target Ce of 4 ng/ ml. Pharmacokinetic model for remifentanil was the Minto model (Height, Weight, and Age) Anesthesia induction and the evaluation of pain were same as control group |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male patients who scheduled for general anesthesia
- Cognitive patients who could understand this study
Key exclusion criteria (1 listed)
- Patients receiving β-receptor blockers, ketamine, clonidine, or any vasoactive substance (i.e. metaraminol, ephedrine) and patients receiving neostigmine, atropine or glycopyrrolate.
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 (ANI)Also: ANI MOC-9V1 and V5 electrocardiographic positions as per the manufacturer's recommendations. The ANI was continuously recorded and displayed with a frequency of 1 Hz. ANI scores measured immediately before propofol administration, half-dose administration (1mg/kg), and full-dose administration (2mg/kg)of propofol. | Device | Control group, Remifentanil group |
Primary outcome
The correlation of Analgesia/nociception Index (ANI) and Propofol injection pain (PIP)
Time frame: Immediately before administration of propofol (2mg/kg)
The correlation of preanesthetic ANI scores and incidence of PIP.
2 secondary outcomes
Incidence and severity of PIP
Time frame: during anesthesia induction ( half-dose (1mg/kg) and full-dose of (2mg/kg) propofol administration)
The correlation of Analgesia/nociception Index (ANI) and Propofol injection pain (PIP)
Time frame: Immediately before administration of propofol (2mg/kg)
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 Oct 2023.
- Background: PubMed 29121287Chanques G, Tarri T, Ride A, Prades A, De Jong A, Carr J, Molinari N, Jaber S. Analgesia nociception index for the assessment of pain in critically ill patients: a diagnostic accuracy study. Br J Anaesth. 2017 Oct 1;119(4):812-820. doi: 10.1093/bja/aex210.
- Background: PubMed 31047645Ledowski T. Objective monitoring of nociception: a review of current commercial solutions. Br J Anaesth. 2019 Aug;123(2):e312-e321. doi: 10.1016/j.bja.2019.03.024. Epub 2019 Apr 30.
- Background: PubMed 31192070Abdullayev R, Yildirim E, Celik B, Topcu Sarica L. Analgesia Nociception Index: Heart Rate Variability Analysis of Emotional Status. Cureus. 2019 Apr 2;11(4):e4365. doi: 10.7759/cureus.4365.
- Individual participant dataSharing planned: No. if other researchers ask, a decision will be made after discussion with the co-authors
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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.
Cheol Lee, M.D,Ph.D principal investigator
Department of anesthesiology and pain medicine
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 (ANI) in people with Pain, Acute and Analgesia, run by Wonkwang 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 2 inclusion and 1 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 Oct 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. Some participants in this study may receive a placebo. 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?
The correlation of Analgesia/nociception Index (ANI) and Propofol injection pain (PIP) (time frame: Immediately before administration of propofol (2mg/kg)). 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 NCT05049577, 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 Oct 2023.