Patients Undergoing Total Laparoscopic HysterectomyNCT04343638
Effect of Intraoperative Nociception Control Based on Analgesia Nociception Index (ANI) Monitoring on Stress Response During Total Laparoscopic Hysterectomy
A study of Patients Undergoing Total Laparoscopic Hysterectomy, run by Yonsei University at 1 site in South Korea.
Trial summary
The "Analgesia Nociception Index" (ANI; MetroDoloris Medical Systems, Lille, France), derived from an electrocardiogram (ECG) trace, has been proposed as a noninvasive guide to analgesia. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Patients Undergoing Total Laparoscopic Hysterectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 May 2020to 28 Oct 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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. patients undergoing total laparoscopic hysterectomy under general anesthesia (American society of anesthesiologists classification 1~3)
Who cannot join
- endometriosis
- AP diameter of uterus > 12cm
- cognitive disorder
- arrhythmia, pacemaker
- chronic opioid use
- diseases affecting autoimmune system (immune disease, diabetic neuropathy)
- use of medications affecting ANI monitor (antimuscarinics, alpha-agonist, beta blocker)
- illiteracy, foreigner
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Severance Hospital
Seoul
About this study
The "Analgesia Nociception Index" (ANI; MetroDoloris Medical Systems, Lille, France), derived from an electrocardiogram (ECG) trace, has been proposed as a noninvasive guide to analgesia. The ANI monitor calculates HR variation with respiration, a response mediated primarily by changes in the parasympathetic nervous system (PNS) stimulation to the sinoatrial node of the heart. The aim of this study is to determine the relation between ANI monitor values and serum catecholamine levels. We will compare the serum catecholamine (norepinephrine, epinephrine) levels of conventional nociception control group and ANI-monitor guided nociception control group at the end of surgery.
- Being tested
- conventional nociception control, ANI monitor guided nociception control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional nociception controlDevice
While Intraoperative opioid will be administered by conventional clinical practice in control arm.
ANI monitor guided nociception controlDevice
The intraoperative opioid will be administered by maintaining the 4-minute moving average of ANI ≥50 in ANI-monitor guided nociception control arm.
| Study group | Role | What they receive |
|---|---|---|
| conventional nociception control arm | Active comparator | Intraoperative opioid will be administered by conventional clinical practice. ANI monitor readings will not be visible to the anesthesiologist. Receives: Device: conventional nociception control |
| ANI-monitor guided nociception control arm | Experimental | Intraoperative opioid will be administered by maintaining the 4-minute moving average of ANI ≥50. Receives: Device: ANI monitor guided nociception control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum catecholamine (norepinephrine, epinephrine) level at the end of surgery
Blood samples for serum catecholamine (norepinephrine, epinephrine) will be drawn at the end of surgery and 1 hour after the end of surgery..
Measured: at the end of surgery (skin closure)
Secondary outcomes (3)
plasma inflammatory markers (IL-6, IL-10, HMGB1)
Blood samples for plasma inflammatory markers (IL-6, IL-10, HMGB1) will be drawn at the end of surgery (skin closure) and 1 hour after the end of surgery.
Measured: at the end of surgery (skin closure) and 1 hour after the end of surgery
hormone level (cortisol, adrenocorticotropic hormone)
blood samples for hormone levels (cortisol, adrenocorticotropic hormone) will be drawn at the end of surgery (skin closure) and 1 hour after the end of surgery.
Measured: at the end of surgery (skin closure) and 1 hour after the end of surgery
serum catecholamine (norepinephrine, epinephrine) level
Blood samples for serum catecholamine (norepinephrine, epinephrine) will be drawn 1hour after surgery.
Measured: 1 hour after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start8 May 2020
- Primary completion28 Oct 2021
- Study completion28 Oct 2021
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 Patients Undergoing Total Laparoscopic HysterectomyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343638
- Sponsor's protocol ID
- 4-2020-0130
- Status last verified
- Dec 2021
- First submitted
- 9 Apr 2020
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim SH, Chang CH, Lee JR, Seo SK, Kwon YI, Lee JH. Effect of analgesia nociception index monitor-based nociception control on perioperative stress responses during laparoscopic surgery in Trendelenburg position: a randomized controlled trial. Front Med (Lausanne). 2023 Aug 4;10:1196153. doi: 10.3389/fmed.2023.1196153. eCollection 2023.
PubMed 37601786
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Nociception Control Based on Analgesia Nociception Index (ANI) Monitoring on Stress Response During Total Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT04343638
- Acronym / sponsor ID
- 4-2020-0130
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 8 May 2020 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 13 Apr 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.
The "Analgesia Nociception Index" (ANI; MetroDoloris Medical Systems, Lille, France), derived from an electrocardiogram (ECG) trace, has been proposed as a noninvasive guide to analgesia. The ANI monitor calculates HR variation with respiration, a response mediated primarily by changes in the parasympathetic nervous system (PNS) stimulation to the sinoatrial node of the heart. The aim of this study is to determine the relation between ANI monitor values and serum catecholamine levels. We will compare the serum catecholamine (norepinephrine, epinephrine) levels of conventional nociception control group and ANI-monitor guided nociception control group at the end of surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional nociception control arm | Active comparator | Device: conventional nociception controlIntraoperative opioid will be administered by conventional clinical practice. ANI monitor readings will not be visible to the anesthesiologist. |
| ANI-monitor guided nociception control arm | Experimental | Device: ANI monitor guided nociception controlIntraoperative opioid will be administered by maintaining the 4-minute moving average of ANI ≥50. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. patients undergoing total laparoscopic hysterectomy under general anesthesia (American society of anesthesiologists classification 1~3)
Key exclusion criteria (8 listed)
- endometriosis
- AP diameter of uterus > 12cm
- cognitive disorder
- arrhythmia, pacemaker
- chronic opioid use
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 |
|---|---|---|
| conventional nociception controlWhile Intraoperative opioid will be administered by conventional clinical practice in control arm. | Device | conventional nociception control arm |
| ANI monitor guided nociception controlThe intraoperative opioid will be administered by maintaining the 4-minute moving average of ANI ≥50 in ANI-monitor guided nociception control arm. | Device | ANI-monitor guided nociception control arm |
Primary outcome
Serum catecholamine (norepinephrine, epinephrine) level at the end of surgery
Time frame: at the end of surgery (skin closure)
Blood samples for serum catecholamine (norepinephrine, epinephrine) will be drawn at the end of surgery and 1 hour after the end of surgery..
3 secondary outcomes
plasma inflammatory markers (IL-6, IL-10, HMGB1)
Time frame: at the end of surgery (skin closure) and 1 hour after the end of surgery
hormone level (cortisol, adrenocorticotropic hormone)
Time frame: at the end of surgery (skin closure) and 1 hour after the end of surgery
serum catecholamine (norepinephrine, epinephrine) level
Time frame: 1 hour after the surgery
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 29 Dec 2021.
- Derived from this study: PubMed 37601786Kim SH, Chang CH, Lee JR, Seo SK, Kwon YI, Lee JH. Effect of analgesia nociception index monitor-based nociception control on perioperative stress responses during laparoscopic surgery in Trendelenburg position: a randomized controlled trial. Front Med (Lausanne). 2023 Aug 4;10:1196153. doi: 10.3389/fmed.2023.1196153. eCollection 2023.
- 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.
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 of Patients Undergoing Total Laparoscopic Hysterectomy, run by Yonsei University 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 8 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 29 Dec 2021. 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?
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?
Serum catecholamine (norepinephrine, epinephrine) level at the end of surgery (time frame: at the end of surgery (skin closure)). 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 NCT04343638, 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 29 Dec 2021.