PainMONIDOL-ANINCT03498820
Analgesia-Nociception Index Guided Intraoperative Remifentanil Administration Versus Standard Practice:Evaluation of Perioperative Opioid Use
A study testing Analgesia Nociception Index and Remifentanil in people with Pain and Anesthesia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study compares two groups of patients undergoing a gynecological surgey under general anesthesia: one group in which intraoperative analgesia is guided by the Analgesia-nociception index, and another group in which intraoperative analgesia is managed as in standard practice. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain, Anesthesia
- What is being tested?
- Analgesia Nociception Index and Remifentanil
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 19 Nov 2018to 13 Mar 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Elective gynecological surgery under general anesthesia
- Duration of surgery 1-7 hours
- Duration of hospital stay > 24 hours
Who cannot join
- chronic pain
- chronic analgesic medication
- neurologic disease
- psychiatric disease
- history of addiction
- kidney or liver failure
- allergy to any anesthetic or analgesic drug
- BMI > 35
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Anesthésie-réanimation chirurgicale - Hôpital Trousseau
Paris, 75012
About this study
Official title: Analgesia-Nociception Index Guided Intraoperative Remifentanil Administration Versus Standard Practice : Evaluation of Perioperative Opioid Use
This study compares two groups of patients undergoing a gynecological surgey under general anesthesia: one group in which intraoperative analgesia is guided by the Analgesia-nociception index, and another group in which intraoperative analgesia is managed as in standard practice. The objective is to assess if the Analgesia Nociception Index may result in a decrease in total analgesic drugs consumption, a decrease in post-operative pain and in chronic pain development.
- Conditions
- Pain, Anesthesia
- Being tested
- Analgesia Nociception Index, Remifentanil
- Keywords
- Analgesia-Nociception Index (ANI), General anesthesia, Opioids, Remifentanil, Pain, Monitoring
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesia Nociception IndexDevice
Also called ANI
: Non invasive monitor based on heart rate variability analysis, assessing the parasympathetic nervous activity
RemifentanilDrug
intravenous short-acting opioid routinely administered during general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Analgesia Nociception Index | Experimental | Intraoperative remifentanil administration guided by the Analgesia Nociception Index Receives: Device: Analgesia Nociception Index |
| Usual practice | Active comparator | Intraoperative remifentanil administration managed in standard practice Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative remifentanil consumption
total dose of remifentanil administered to the patient during general anesthesia
Measured: up to 7 hours after the beginning of general anesthesia
Secondary outcomes (3)
Postoperative morphine consumption
total dose of morphine administered to the patient to manage postoperative pain during the first 24 hours following surgery
Measured: obtained 24 hours after the end of general anesthesia
Persistent pain
phone interview asking the patient if she still feels pain related to the surgery
Measured: : obtained one month after surgery
Persistent pain
phone interview asking the patient if she still feels pain related to the surgery
Measured: Obtained three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start19 Nov 2018
- Primary completion19 Dec 2019
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nada SABOURDIN, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498820
- Sponsor's protocol ID
- P171003J
- Acronym
- MONIDOL-ANI
- Status last verified
- May 2021
- First submitted
- 26 Feb 2018
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia-Nociception Index Guided Intraoperative Remifentanil Administration Versus Standard Practice : Evaluation of Perioperative Opioid Use
- ClinicalTrials.gov ID
- NCT03498820
- Acronym / sponsor ID
- MONIDOL-ANI / P171003J
- Conditions
- Pain, Anesthesia
- Keywords
- Analgesia-Nociception Index (ANI), General anesthesia, Opioids, Remifentanil, Pain, Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 17 Apr 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.
This study compares two groups of patients undergoing a gynecological surgey under general anesthesia: one group in which intraoperative analgesia is guided by the Analgesia-nociception index, and another group in which intraoperative analgesia is managed as in standard practice. The objective is to assess if the Analgesia Nociception Index may result in a decrease in total analgesic drugs consumption, a decrease in post-operative pain and in chronic pain development.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Analgesia Nociception Index | Experimental | Device: Analgesia Nociception IndexIntraoperative remifentanil administration guided by the Analgesia Nociception Index |
| Usual practice | Active comparator | Drug: RemifentanilIntraoperative remifentanil administration managed in standard practice |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Elective gynecological surgery under general anesthesia
- Duration of surgery 1-7 hours
- Duration of hospital stay > 24 hours
Key exclusion criteria (8 listed)
- chronic pain
- chronic analgesic medication
- neurologic disease
- psychiatric disease
- history of addiction
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 IndexAlso: ANI: Non invasive monitor based on heart rate variability analysis, assessing the parasympathetic nervous activity | Device | Analgesia Nociception Index |
| Remifentanilintravenous short-acting opioid routinely administered during general anesthesia | Drug | Usual practice |
Primary outcome
Intraoperative remifentanil consumption
Time frame: up to 7 hours after the beginning of general anesthesia
total dose of remifentanil administered to the patient during general anesthesia
3 secondary outcomes
Postoperative morphine consumption
Time frame: obtained 24 hours after the end of general anesthesia
Persistent pain
Time frame: : obtained one month after surgery
Persistent pain
Time frame: Obtained three months after 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 24 May 2021.
- 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.
Nada SABOURDIN, MD principal investigator
Assistance Publique - Hôpitaux de Paris
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 and Remifentanil in people with Pain and Anesthesia, run by Assistance Publique - Hôpitaux de Paris 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 3 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 24 May 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 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?
Intraoperative remifentanil consumption (time frame: up to 7 hours after the beginning of general anesthesia). 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 24 May 2021.