SurgeryANINCT03103698
The Interest of the ANI in the Monitoring of Peroperative Analgesia in Bariatric Surgery
A study testing To demonstrate the monitoring of perioperative analgesia and Standard preoperative evaluation of analgesia in people with Surgery and Obese, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The intraoperative assessment of analgesia remains problematic and no analgesia monitor is used in routine practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- To demonstrate the monitoring of perioperative analgesia and Standard preoperative evaluation of analgesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2016to 1 Oct 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major Patient Age ≥ 18 years
- Adult patients candidate for planned surgery with BMI> 30.
- Affiliation to social security.
- Patients who were clearly informed and signed consent.
Who cannot join
- Patient with a heart rhythm disorder.
- Respiratory rate less than 9 cycles / min.
- Irregular spontaneous ventilation.
- Perioperative use of a drug acting on the sinus node (eg atropine, etc.)
- History of neuropathic pain.
- Patient under morphine until the day before surgery.
- Patients under guardianship or curatorship or deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Interest of the ANI in the Monitoring of Peroperative Analgesia in Bariatric Surgery: a Randomized Single Blind Study.
The intraoperative assessment of analgesia remains problematic and no analgesia monitor is used in routine practice.
Read the detailed description
The intraoperative assessment of analgesia remains problematic and no analgesia monitor is used in routine practice. Currently, this assessment is based on hemodynamic changes, although hypertension or tachycardia is neither sensitive nor specific. An overdose in opioids exposes to many side effects ranging from respiratory depression to phenomena of post-operative hyperalgesia. Conversely, an under-dosage in opioids is at the origin of a nociceptive stress whose neurovegetative and hormonal response can aggravate post-operative morbidity or promote the occurrence of implicit memorization.
Nociceptive influx can not be detected directly. However, its ascent to the somesthetic area of the cerebral cortex leads to physiological reactions that can be evaluated. In particular, there are numerous anatomical and functional interactions between the autonomic nervous system and the nociceptive tract in the brain stem. These interactions are mainly at the level of the gray periqueducal substance, the rostral ventro-lateral bulbous region, the solitary tract nucleus and the hypothalamus. The nociceptive influx thus leads to changes in the activity of the ANS. The study of changes in the ANS would therefore be a method of assessing the intensity of the nociceptive influx.
This objective method can be used in the non-communicating or unconscious patient to evaluate the pain and to adapt the analgesic treatment to the best.
Obese patients who receive surgical management often have comorbidities such as restrictive syndrome, or obstructive sleep apnea syndrome. They thus represent a target of choice in perioperative analgesic optimization in order to avoid respiratory complications that may be related to over or under assay of morphine such as atelectasis, alveolar hypoventilation.
It is hypothesized that this device is more effective for the intraoperative evaluation of analgesia than the usual method based on hemodynamic changes in intraoperatively anesthetized patients for bariatric surgery.
- Being tested
- To demonstrate the monitoring of perioperative analgesia, Standard preoperative evaluation of analgesia
- Keywords
- analgesia per-operative
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To demonstrate the monitoring of perioperative analgesiaDevice
To demonstrate that the monitoring of perioperative analgesia by the ANI device decreases intraoperative morphine consumption compared with conventional monitoring based on haemodynamic variations.
Standard preoperative evaluation of analgesiaOther
To demonstrate that the monitoring of perioperative analgesia by the ANI device decreases intraoperative morphine consumption compared with conventional monitoring based on haemodynamic variations.
| Study group | Role | What they receive |
|---|---|---|
| Monitoring of perioperative analgesia by the ANI device | Other | Not described Receives: Device: To demonstrate the monitoring of perioperative analgesia |
| conventional monitoring based on hemodynamic variations. | Other | Not described Receives: Other: Standard preoperative evaluation of analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of morphine used per operatively in the two groups
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start17 Oct 2016
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103698
- Sponsor's protocol ID
- PI2015_843_0032
- Acronym
- ANI
- Status last verified
- Nov 2025
- First submitted
- 31 Mar 2017
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interest of the ANI in the Monitoring of Peroperative Analgesia in Bariatric Surgery: a Randomized Single Blind Study.
- ClinicalTrials.gov ID
- NCT03103698
- Acronym / sponsor ID
- ANI / PI2015_843_0032
- Keywords
- analgesia per-operative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 17 Oct 2016 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 6 Apr 2017 (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 intraoperative assessment of analgesia remains problematic and no analgesia monitor is used in routine practice.
Detailed description
The intraoperative assessment of analgesia remains problematic and no analgesia monitor is used in routine practice. Currently, this assessment is based on hemodynamic changes, although hypertension or tachycardia is neither sensitive nor specific. An overdose in opioids exposes to many side effects ranging from respiratory depression to phenomena of post-operative hyperalgesia. Conversely, an under-dosage in opioids is at the origin of a nociceptive stress whose neurovegetative and hormonal response can aggravate post-operative morbidity or promote the occurrence of implicit memorization.
Nociceptive influx can not be detected directly. However, its ascent to the somesthetic area of the cerebral cortex leads to physiological reactions that can be evaluated. In particular, there are numerous anatomical and functional interactions between the autonomic nervous system and the nociceptive tract in the brain stem. These interactions are mainly at the level of the gray periqueducal substance, the rostral ventro-lateral bulbous region, the solitary tract nucleus and the hypothalamus. The nociceptive influx thus leads to changes in the activity of the ANS. The study of changes in the ANS would therefore be a method of assessing the intensity of the nociceptive influx.
This objective method can be used in the non-communicating or unconscious patient to evaluate the pain and to adapt the analgesic treatment to the best.
Obese patients who receive surgical management often have comorbidities such as restrictive syndrome, or obstructive sleep apnea syndrome. They thus represent a target of choice in perioperative analgesic optimization in order to avoid respiratory complications that may be related to over or under assay of morphine such as atelectasis, alveolar hypoventilation.
It is hypothesized that this device is more effective for the intraoperative evaluation of analgesia than the usual method based on hemodynamic changes in intraoperatively anesthetized patients for bariatric surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitoring of perioperative analgesia by the ANI device | Other | Device: To demonstrate the monitoring of perioperative analgesia |
| conventional monitoring based on hemodynamic variations. | Other | Other: Standard preoperative evaluation of analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major Patient Age ≥ 18 years
- Adult patients candidate for planned surgery with BMI> 30.
- Affiliation to social security.
- Patients who were clearly informed and signed consent.
Key exclusion criteria (7 listed)
- Patient with a heart rhythm disorder.
- Respiratory rate less than 9 cycles / min.
- Irregular spontaneous ventilation.
- Perioperative use of a drug acting on the sinus node (eg atropine, etc.)
- History of neuropathic pain.
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 |
|---|---|---|
| To demonstrate the monitoring of perioperative analgesiaTo demonstrate that the monitoring of perioperative analgesia by the ANI device decreases intraoperative morphine consumption compared with conventional monitoring based on haemodynamic variations. | Device | Monitoring of perioperative analgesia by the ANI device |
| Standard preoperative evaluation of analgesiaTo demonstrate that the monitoring of perioperative analgesia by the ANI device decreases intraoperative morphine consumption compared with conventional monitoring based on haemodynamic variations. | Other | conventional monitoring based on hemodynamic variations. |
Primary outcome
The amount of morphine used per operatively in the two groups
Time frame: 1 day
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 19 Nov 2025.
Related trials for Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
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 To demonstrate the monitoring of perioperative analgesia and Standard preoperative evaluation of analgesia in people with Surgery and Obese, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 7 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 19 Nov 2025. 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 France. 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?
The amount of morphine used per operatively in the two groups (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2025.