General AnesthesiaNCT05063461
Evaluation of the Analgesia Nociception Index With Varying Remifentanil Concentrations Under Sevoflurane
A study testing Tetanic stimulation and Skin incision in people with General Anesthesia, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
Analgesia Nociception Index（ANI）which is derived from heart rate variability can be used to detect noxious stimulation during propofol while changing remifentanil concentrations. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Tetanic stimulation and Skin incision
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2021to 1 Mar 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18- 65 years
- ASA physical status I or II
- Elective surgery in general anesthesia planned
- Written informed consent
Who cannot join
- Use of CNS-active medication or abuse of alcohol
- Presents of any neuromuscular or neurologic disease
- History of cardiac arrhythmia
- Pregnancy or using a pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Analgesia Nociception Index（ANI）which is derived from heart rate variability can be used to detect noxious stimulation during propofol while changing remifentanil concentrations. The aim of this study is to verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination during sevoflurane while changing remifentanil concentrations.
Read the detailed description
General anesthesia with sevoflurane and remifentanil is widely used in minor surgeries. Monitoring noxious stimulation during general anesthesia is still worth further studies and reaching clinical consensus. Analgesia Nociception Index can be used to detect noxious stimulation during propofol while changing remifentanil concentrations. Previous studies suggest that an ANI≥50 can be useful in detecting sufficient analgesia for patients who cannot self-report pain. The aim of this study is to verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination during sevoflurane while changing remifentanil concentrations.
- Conditions
- General Anesthesia
- Being tested
- Tetanic stimulation, Skin incision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanic stimulationDevice
For each participant, record the first concentration that ANI≥50 after the tetanic stimuli, as the sufficient concentration.
Skin incisionProcedure or surgery
Infuse the sufficient concentration for at least 5min of the steady-state period, then surgical stimulus is applied. The surgical stimulus is defined as the first skin incision to establish pneumoperitoneum.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane with different site effect concentrations of remifentanil | Experimental | The tetanic stimulus is conducted between laryngeal mask intubation and surgical stimulation, while no other noxious stimuli are presented. The effect site concentration of remifentanil is increased step-by-step via a Target Controlled infusion device to a concentration of 2, 4, 6 ng/ml. At least 5min of the steady-state period is maintained before tetanic stimulus. Receives: Device: Tetanic stimulation; Procedure: Skin incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
To verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination.
Tetanic stimulations are applied at different effect site concentrations of remifentanil under sevoflurane anesthesia. ANI is range from 0-100. Bigger number means better analgesic level. ANI≥50 is considered to be under adequate analgesia. Tetanic stimulation is a standard tester of nociceptive stimulus. The number of ANI will fall down if the patient is feeling pain.
Measured: Change from Baseline ANI that 2 minutes after applied tetanic stilumation
Secondary outcomes (3)
The ANI predictability for tetanic noxious stimuli
ANI is range from 0-100. Bigger number means better analgesic level. ANI≥50 is considered to be under adequate analgesia. The number of ANI will fall down if the patient is feeling pain.
Measured: Change from Baseline Systolic Blood Pressure that 2 minutes after applied tetanic stilumation
The heart rate predictability for tetanic noxious stimuli
Heart Rate will go up if patient is feeling pain.
Measured: Change from Baseline Heart Rate that 2 minutes after applied tetanic stilumation
The Bispectral Index predictability for tetanic noxious stimuli
Bispectral Index will go up if patient is feeling pain.
Measured: Change from Baseline Bispectral Index that 2 minutes after applied tetanic stilumation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start25 Sep 2021
- Primary completion28 Feb 2023
- Study completion1 Mar 2023
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 General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changwei Wei, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063461
- Sponsor's protocol ID
- 00375930
- Status last verified
- Mar 2023
- First submitted
- 15 Sep 2021
- Last updated
- 22 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang L, Wang X, Wen H. Evaluation of the effectiveness of analgesia nociception index (ANI) predictability for surgical stimuli under personal analgesic sufficiency status (PASS) measured by pre-tetanus-induced ANI: a pilot study. J Clin Monit Comput. 2023 Dec;37(6):1585-1591. doi: 10.1007/s10877-023-01044-y. Epub 2023 Jul 7.
PubMed 37418059
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesia Nociception Index With Varying Remifentanil Concentrations Under Sevoflurane
- ClinicalTrials.gov ID
- NCT05063461
- Acronym / sponsor ID
- 00375930
- Conditions
- General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 25 Sep 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 1 Oct 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.
Analgesia Nociception Index（ANI）which is derived from heart rate variability can be used to detect noxious stimulation during propofol while changing remifentanil concentrations. The aim of this study is to verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination during sevoflurane while changing remifentanil concentrations.
Detailed description
General anesthesia with sevoflurane and remifentanil is widely used in minor surgeries. Monitoring noxious stimulation during general anesthesia is still worth further studies and reaching clinical consensus. Analgesia Nociception Index can be used to detect noxious stimulation during propofol while changing remifentanil concentrations. Previous studies suggest that an ANI≥50 can be useful in detecting sufficient analgesia for patients who cannot self-report pain. The aim of this study is to verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination during sevoflurane while changing remifentanil concentrations.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane with different site effect concentrations of remifentanil | Experimental | Device: Tetanic stimulation, Procedure: Skin incisionThe tetanic stimulus is conducted between laryngeal mask intubation and surgical stimulation, while no other noxious stimuli are presented. The effect site concentration of remifentanil is increased step-by-step via a Target Controlled infusion device to a concentration of 2, 4, 6 ng/ml. At least 5min of the steady-state period is maintained before tetanic stimulus. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18- 65 years
- ASA physical status I or II
- Elective surgery in general anesthesia planned
- Written informed consent
Key exclusion criteria (4 listed)
- Use of CNS-active medication or abuse of alcohol
- Presents of any neuromuscular or neurologic disease
- History of cardiac arrhythmia
- Pregnancy or using a pacemaker
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 |
|---|---|---|
| Tetanic stimulationFor each participant, record the first concentration that ANI≥50 after the tetanic stimuli, as the sufficient concentration. | Device | Sevoflurane with different site effect concentrations of remifentanil |
| Skin incisionInfuse the sufficient concentration for at least 5min of the steady-state period, then surgical stimulus is applied. The surgical stimulus is defined as the first skin incision to establish pneumoperitoneum. | Procedure or surgery | Sevoflurane with different site effect concentrations of remifentanil |
Primary outcome
To verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination.
Time frame: Change from Baseline ANI that 2 minutes after applied tetanic stilumation
Tetanic stimulations are applied at different effect site concentrations of remifentanil under sevoflurane anesthesia. ANI is range from 0-100. Bigger number means better analgesic level. ANI≥50 is considered to be under adequate analgesia. Tetanic stimulation is a standard tester of nociceptive stimulus. The number of ANI will fall down if the patient is feeling pain.
3 secondary outcomes
The ANI predictability for tetanic noxious stimuli
Time frame: Change from Baseline Systolic Blood Pressure that 2 minutes after applied tetanic stilumation
The heart rate predictability for tetanic noxious stimuli
Time frame: Change from Baseline Heart Rate that 2 minutes after applied tetanic stilumation
The Bispectral Index predictability for tetanic noxious stimuli
Time frame: Change from Baseline Bispectral Index that 2 minutes after applied tetanic stilumation
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 22 Mar 2023.
- Derived from this study: PubMed 37418059Yang L, Wang X, Wen H. Evaluation of the effectiveness of analgesia nociception index (ANI) predictability for surgical stimuli under personal analgesic sufficiency status (PASS) measured by pre-tetanus-induced ANI: a pilot study. J Clin Monit Comput. 2023 Dec;37(6):1585-1591. doi: 10.1007/s10877-023-01044-y. Epub 2023 Jul 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetanic stimulation and Skin incision in people with General Anesthesia, run by Beijing Chao Yang Hospital at 1 site in China.
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 4 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 22 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 China. 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?
To verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination. (time frame: Change from Baseline ANI that 2 minutes after applied tetanic stilumation). 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 NCT05063461, 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 22 Mar 2023.