Immediate Severe Postoperative PainPhase 3GOALDANNCT03618082
GOAL-Directed ANalgesia (GOALDAN)
A Phase 3 study testing Anesthesic agent guided by ANI (Interventional Group) and Administration of the lowest effective concentration of desflurane (Interventional Group) in people with Immediate Severe Postoperative Pain and Perioperative Hemodynamic, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The primary purpose of GOALDAN study is to demonstrate the superiority of a targeted perioperative analgesic strategy by the ANI over the usual practice on the incidence of immediate postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Immediate Severe Postoperative Pain, Perioperative Hemodynamic
- What is being tested?
- Anesthesic agent guided by ANI (Interventional Group) and Administration of the lowest effective concentration of desflurane (Interventional Group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2019to 13 Aug 2022
- Phase
- Phase 3
- 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
- 18≤ Age <65 years old
- Patient operated on a scheduled surgery under general anesthesia
- Patient with a American Society of Anesthesiologists (ASA) score of I to III
- Patient having given his consent in the manner described in Article L1122-1-1 of the Public Health Code
- Patient affiliated with a social security regimen or beneficiary of such a regimen
Who cannot join
- general anesthesia without extubating (laryngeal mask)
- neuraxial preoperative regional anesthesia (epidural or rachianalgesia)
- opioid-free anesthesia
- preoperative peripheral nerve block with analgesic aim (infiltration of a local surgical anesthetic or transversus abdominis plane block-TAP block-authorized)
- arrhythmia or the presence of a pacemaker
- ambulatory surgery
Show all 21Show fewer
- cardiac or cerebral surgery
- obstetrical surgery (caesarean)
- surgery performed with neuraxial regional anesthesia or peripheral anesthesia alone
- surgery performed in prone position
- urgent surgery
- endoscopic procedure or interventional radiology
- chronic pain treated with opiates
- expected surgery duration < 1h
- pathology of the autonomic nervous system (epilepsy, history of transient attack or stroke, paraplegia, hemiplegia, orthostatic hypotension, autonomic dysfunction)
- Patient with cardiogenic or septic shock
- Continuous infusion of vasoactive agents (ephedrine, phenylephrine, adrenaline, or noradrenaline)
- Postoperative transfer planned in intensive care unit (intubated patient) after surgery
- Person under tutorship or curatorship
- Pregnancy
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
Lise LACLAUTRE, 04 73 75 49 63, drci@chu-clermontferrand.fr
Jean-Etienne BAZIN
About this study
Official title: Effect of Targeted Analgesia to ANI (Analgesia/ Nociception Index) During General Anesthesia on Immediate Postoperative Pain and Perioperative Hemodynamic: Multicenter Randomized Controlled Study
The primary purpose of GOALDAN study is to demonstrate the superiority of a targeted perioperative analgesic strategy by the ANI over the usual practice on the incidence of immediate postoperative pain.
The investigators hypothesized that a prophylactic administration of morphine in patients with risk of postoperative pain determined by the ANI at the end of the intervention would reduce the incidence of immediate postoperative pain and that the targeted analgesia to ANI and minimal alveolar concentration (MAC) of desflurane could improve the perioperative hemodynamic, and the postoperative becoming.
Read the detailed description
Visits:
- The patient will arrive in the department the day before the surgical intervention (D-1). During this preoperative visit (D-1), the investigator
- will preselect potentially eligible patients
- will offer to participate to this study
- will give the notice form to the patients
- will present the research: objectives, benefits and constraints for the patients
- will check that patients understand the verbally administered Numeric Rating Scale (NRS) for the assessment of the postoperative This verbally administered NRS is routinely presented to all patients at a surgical intervention.
- The intervention day (D0):
The investigator will collect the signed consent form after having ascertained the understanding of the notice form by the patient and checking the inclusion and non-inclusion criteria.
The randomization will be done via the eCRF module (allocation group and number) and the preoperative data registration in the eCRF.
- Surgical intervention (D0): All patients will receive a usual multimodal analgesia associating level 1 analgesics (acetaminophen, ketoprofen, nefopam) or level 2 (tramadol) administered 30 to 60 min before the foreseeable end of the surgical intervention. All patients will receive 0.1 to 0.2 mg/kg of morphine within the 30 min preceding the end of the surgical intervention according to the usual practice.
Once the patient transferred to the recovery room, the assessment of the primary outcome (verbally administered NRS) will be done by the nurse responsible for the patient, when the patient arrives, during the stay and when the patient leaves the recovery room. If the verbally NRS > 3, a morphine titration by IV administration of 2 to 3 mg of morphine will be realised then the verbally NRS will be collected 5 min after, according to the usual practice. This morphine titration will continued until the obtaining of a verbal NRS ≤ 3.
As an alternative to this morphine titration, where possible, a peripheral nerve block may be proposed to the patient and performed by the investigator to relieve the patient.
If the patient is transferred directly in ICU without being extubated at the end of the intervention and so without transiting by the recovery room, the patient will be excluded from the study.
- Being tested
- Anesthesic agent guided by ANI (Interventional Group), Administration of the lowest effective concentration of desflurane (Interventional Group)
- Keywords
- prospective, single blind, multicenter, randomized, controlled, Analgesia Nociception Index (ANI), Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesic agent guided by ANI (Interventional Group)Drug
Anesthesic agent guided by ANI (Interventional Group) The remifentanil administration will be piloted by the ANI, as well as the prophylactic administration of morphine at the end of the intervention.
Administration of the lowest effective concentration of desflurane (Interventional Group)Drug
Administration of the lowest effective concentration of desflurane (Interventional Group) Desflurane will be administered with a targeted purpose of minimal alveolar concentration (MAC).
| Study group | Role | What they receive |
|---|---|---|
| usual practice | Active comparator | control group (usual practice): patients receiving a general anesthesia with propofol, ketamine and remifentanil with or without curare for the induction, and desflurane and remifentanil (with or without curare) for the maintenance. The dosage of the anesthetic agent, as well as the prophylactic administration of morphine at the end of the intervention, will be decided by the anesthesiologist. Receives: Drug: Anesthesic agent guided by ANI (Interventional Group); Drug: Administration of the lowest effective concentration of desflurane (Interventional Group) |
| targeted analgesia to ANI | Experimental | experimental group: patients receiving a general anesthesia with propofol, ketamine and remifentanil with or without curare for the induction, and desflurane and remifentanil (with or without curare) for the maintenance, as well as the prophylactic administration of morphine at the end of the intervention, will be administered according to the ANI.
- In addition, desflurane will be administered with a targeted purpose of minimal alveolar concentration (MAC). Receives: Drug: Anesthesic agent guided by ANI (Interventional Group); Drug: Administration of the lowest effective concentration of desflurane (Interventional Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
immediate maximum postoperative pain in recovery room defined by a score > 3 on a verbally administered numeric rating scale (NRS) variating from 0 to 10.
Once the patient transferred to the recovery room, the assessment of the primary outcome (verbally administered NRS) will be done by the nurse responsible for the patient, when the patient arrives, during the stay and when the patient leaves the recovery room
Measured: From day 0 to day 28
Secondary outcomes (11)
Maximum pain score during the first postoperative day (numeric rating scale variating from 0 to 10).
The patient chooses on a scale numeric range a number between 0 and 10 to characterise the intensity of the pain during the first postoperative day : 0 if the pain is mild (better outcome), 10 if the pain is severe (worse outcome).This numeric rating scale will be assessed every 6 hours during the 24 first hours (H0 = arrival hour at the recovery room).
Measured: every 6 hours during the 24 first hours.
Score Postoperative D1 Pain Management (numeric rating scale variating from 0 to 10)
The patient chooses on a scale numeric range from 0 to 10, a number which characterises the overall satisfaction of pain management : if the pain management is correct (10) or if the pain management is not correct (0).
Measured: At day 1
dose of morphine in the recovery room
will be compared between groups by test t of Student or test not parametrize of Mann-Whitney if the conditions of the test t are not respected (study of the normality, homoscedasticity studied by test of Fisher-Snedecor). The results will be expressed in terms of size of effect and reliable interval in associated 95 %. These analyses can be secondly completed, in multivariate situation, by models of regression of linear type; covariables will be considered with regard to the clinical relevance and the results of analyses univariate preliminary. The results will be expressed in terms of coefficients of regression and reliable intervals in associated 95 %.
Measured: At day 0
postoperative nausea and vomiting in the recovery room
In both groups, the prevention of the nausea and the vomitings will be administered according to the current recommendations (dexamethasone 4 mg and droperidol 0,625-1,25 mg it peroperatoire at the patients at risk, defined by a score of Apfel 2). In case of NVPO during the first 24 post-operative hours, the administration of 4 mg of ondansétron will be realized, according to the recommendations.
Measured: At day 1
total dose of morphine during the first postoperative day (mg)
will be compared between groups by test t of Student or test not parametrique of Mann-Whitney if the conditions of the test t are not respected (study of the normality, homoscedasticity studied by test of Fisher-Snedecor). The results will be expressed in terms of size of effect and reliable interval in associated 95 %. These analyses can be secondly completed, in multivariate situation, by models of regression of linear type; covariables will be considered with regard to the clinical relevance and the results of analyses univariées preliminary. The results will be expressed in terms of coefficients of regression and reliable intervals in associated 95 %.
Measured: At day 1
regional anesthesia for postoperative analgesic purposes
Measured: At day 1
the duration in the recovery room (time to obtain an Aldrete score ≥9) (min)
will be compared between groups by test t of Student or test not parametrize of Mann-Whitney if the conditions of the test t are not respected (study of the normality, homoscedasticity studied by test of Fisher-Snedecor). The results will be expressed in terms of size of effect and reliable interval in associated 95 %. These analyses can be secondly completed, in multivariate situation, by models of regression of linear type; covariables will be considered with regard to the clinical relevance and the results of analyses univariées preliminary. The results will be expressed in terms of coefficients of regression and reliable intervals in associated 95 %.
Measured: From day 0 to day 28
destination of the patient after surgery (unit of surgery, continuous care, resuscitation).
Test of chi² or exact test of Fisher if necessary. Secondly, this analysis can be completed, in multivariate situation, by a mixed generalized linear model of logistic type allowing to take into account variability inter and intracentre. Covariables will be considered with regard to the clinical relevance (other treatments, use of vasopresseurs continuous, type of surgery) and results of analyses univariate preliminary. The results will be expressed in terms of reports of the quotations and the reliable intervals in associated 95 %.
Measured: From day 0 to day 28
incidence of postoperative complications on the first and seventh postoperative days for hospitalized patients using Post-Operative Morbidity Survey (POMS).
Post-operative complications in the first and seventh day post-operative will be compared by test of chi² or where necessary, by the exact test of Fisher.
Secondly, this analysis can be completed, in multivariate situation, by a mixed generalized linear model of logistic type allowing to take into account variability inter and intracentre. Covariables will be considered with regard to the clinical relevance (other treatments, use of vasopresseurs continuous, type of surgery) and results of analyses univariées preliminary. The results will be expressed in terms of reports of the quotations and the reliable intervals in associated 95 %.
Measured: From day 0 to day 1 and until day 7
duration of the hospitalization (day)
Duration of hospitalization will be compared between groups by test t of Student or test not paramétrique of Mann-Whitney if the conditions of the test t are not respected (study of the normality, homoscédasticité studied by test of Fisher-Snedecor). The results will be expressed in terms of size of effect and reliable interval in associated 95 %. These analyses can be secondly completed, in multivariate situation, by models of regression of linear type; covariables will be considered with regard to the clinical relevance and the results of analyses univariées preliminary. The results will be expressed in terms of coefficients of regression and reliable intervals in associated 95 %.
Measured: From day 0 to day 28
Mortality at Day 28
The survival to day 28 comment surgery will be estimated(esteemed) by curve of Kaplan-Meier and compared between groups of randomization by test of the log-rank in univariate situation and model of Cox in multivariated analysis. The results will be expressed in terms of relationship of immediate risks and reliable intervals in associated 95 %.
Measured: At day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start6 Jun 2019
- Primary completion13 May 2022 (estimated)
- Study completion13 Aug 2022 (estimated)
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 Immediate Severe Postoperative PainStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization in 2 groups 1- control group : patients receiving a general anesthesia with propofol, ketamine and remifentanil with or without curare for the induction, desflurane, remifentanil (curare or not) for the maintenance, the dosage of the anesthetic agents will be decided by the anesthesiologist responsible for the patient based on the usual practice. 2- experimental group : patients receiving a general anesthesia with propofol, ketamine and remifentanil with or without curare for the induction, desflurane, remifentanil (curare or not) for the maintenance, administered according to a specific algorithm. In this group, the remifentanil administration will be piloted by the ANI (50 to 80), as well as the prophylactic administration of morphine at the end of the intervention. Administration of 2mg of morphine immediately before the extubating if ANI\<50. And, desflurane will be administered with a targeted purpose of 0.8 to 1.2 MAC.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Apicil
- Responsible party
- Sponsor
- Investigators
- Jean-Etienne BAZIN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618082
- Sponsor's protocol ID
- CHU-401
- Other IDs
- 2017-A03268-45
- Acronym
- GOALDAN
- Status last verified
- Jul 2020
- First submitted
- 18 Jul 2018
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Michalot A, Bazin JE, Richebe P, Allaouchiche B, Boselli E. Effect of GOAL-Directed ANalgesia using ANI (Analgesia/Nociception Index) during general anesthesia on immediate postoperative pain and intraoperative hemodynamics in adult patients (GOALDAN study): a study protocol for randomized, controlled, multicenter trial. Trials. 2022 Apr 25;23(1):353. doi: 10.1186/s13063-022-06273-1.
PubMed 35468803
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Targeted Analgesia to ANI (Analgesia/ Nociception Index) During General Anesthesia on Immediate Postoperative Pain and Perioperative Hemodynamic: Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03618082
- Acronym / sponsor ID
- GOALDAN / CHU-401
- Keywords
- prospective, single blind, multicenter, randomized, controlled, Analgesia Nociception Index (ANI), Postoperative pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Fondation Apicil
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 13 May 2022 (estimated)
- Study completion
- 13 Aug 2022 (estimated)
- First posted
- 7 Aug 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.
The primary purpose of GOALDAN study is to demonstrate the superiority of a targeted perioperative analgesic strategy by the ANI over the usual practice on the incidence of immediate postoperative pain.
The investigators hypothesized that a prophylactic administration of morphine in patients with risk of postoperative pain determined by the ANI at the end of the intervention would reduce the incidence of immediate postoperative pain and that the targeted analgesia to ANI and minimal alveolar concentration (MAC) of desflurane could improve the perioperative hemodynamic, and the postoperative becoming.
Detailed description
Visits:
- The patient will arrive in the department the day before the surgical intervention (D-1). During this preoperative visit (D-1), the investigator
- will preselect potentially eligible patients
- will offer to participate to this study
- will give the notice form to the patients
- will present the research: objectives, benefits and constraints for the patients
- will check that patients understand the verbally administered Numeric Rating Scale (NRS) for the assessment of the postoperative This verbally administered NRS is routinely presented to all patients at a surgical intervention.
- The intervention day (D0):
The investigator will collect the signed consent form after having ascertained the understanding of the notice form by the patient and checking the inclusion and non-inclusion criteria.
The randomization will be done via the eCRF module (allocation group and number) and the preoperative data registration in the eCRF.
- Surgical intervention (D0): All patients will receive a usual multimodal analgesia associating level 1 analgesics (acetaminophen, ketoprofen, nefopam) or level 2 (tramadol) administered 30 to 60 min before the foreseeable end of the surgical intervention. All patients will receive 0.1 to 0.2 mg/kg of morphine within the 30 min preceding the end of the surgical intervention according to the usual practice.
Once the patient transferred to the recovery room, the assessment of the primary outcome (verbally administered NRS) will be done by the nurse responsible for the patient, when the patient arrives, during the stay and when the patient leaves the recovery room. If the verbally NRS > 3, a morphine titration by IV administration of 2 to 3 mg of morphine will be realised then the verbally NRS will be collected 5 min after, according to the usual practice. This morphine titration will continued until the obtaining of a verbal NRS ≤ 3.
As an alternative to this morphine titration, where possible, a peripheral nerve block may be proposed to the patient and performed by the investigator to relieve the patient.
If the patient is transferred directly in ICU without being extubated at the end of the intervention and so without transiting by the recovery room, the patient will be excluded from the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomization in 2 groups 1- control group : patients receiving a general anesthesia with propofol, ketamine and remifentanil with or without curare for the induction, desflurane, remifentanil (curare or not) for the maintenance, the dosage of the anesthetic agents will be decided by the anesthesiologist responsible for the patient based on the usual practice. 2- experimental group : patients receiving a general anesthesia with propofol, ketamine and remifentanil with or without curare for the induction, desflurane, remifentanil (curare or not) for the maintenance, administered according to a specific algorithm. In this group, the remifentanil administration will be piloted by the ANI (50 to 80), as well as the prophylactic administration of morphine at the end of the intervention. Administration of 2mg of morphine immediately before the extubating if ANI<50. And, desflurane will be administered with a targeted purpose of 0.8 to 1.2 MAC.
| Arm | Type | Receives |
|---|---|---|
| usual practice | Active comparator | Drug: Anesthesic agent guided by ANI (Interventional Group), Drug: Administration of the lowest effective concentration of desflurane (Interventional Group)control group (usual practice): patients receiving a general anesthesia with propofol, ketamine and remifentanil with or without curare for the induction, and desflurane and remifentanil (with or without curare) for the maintenance. The dosage of the anesthetic agent, as well as the prophylactic administration of morphine at the end of the intervention, will be decided by the anesthesiologist. |
| targeted analgesia to ANI | Experimental | Drug: Anesthesic agent guided by ANI (Interventional Group), Drug: Administration of the lowest effective concentration of desflurane (Interventional Group)experimental group: patients receiving a general anesthesia with propofol, ketamine and remifentanil with or without curare for the induction, and desflurane and remifentanil (with or without curare) for the maintenance, as well as the prophylactic administration of morphine at the end of the intervention, will be administered according to the ANI. - In addition, desflurane will be administered with a targeted purpose of minimal alveolar concentration (MAC). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18≤ Age <65 years old
- Patient operated on a scheduled surgery under general anesthesia
- Patient with a American Society of Anesthesiologists (ASA) score of I to III
- Patient having given his consent in the manner described in Article L1122-1-1 of the Public Health Code
- Patient affiliated with a social security regimen or beneficiary of such a regimen
Key exclusion criteria (21 listed)
- general anesthesia without extubating (laryngeal mask)
- neuraxial preoperative regional anesthesia (epidural or rachianalgesia)
- opioid-free anesthesia
- preoperative peripheral nerve block with analgesic aim (infiltration of a local surgical anesthetic or transversus abdominis plane block-TAP block-authorized)
- arrhythmia or the presence of 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 |
|---|---|---|
| Anesthesic agent guided by ANI (Interventional Group)Anesthesic agent guided by ANI (Interventional Group) The remifentanil administration will be piloted by the ANI, as well as the prophylactic administration of morphine at the end of the intervention. | Drug | targeted analgesia to ANI, usual practice |
| Administration of the lowest effective concentration of desflurane (Interventional Group)Administration of the lowest effective concentration of desflurane (Interventional Group) Desflurane will be administered with a targeted purpose of minimal alveolar concentration (MAC). | Drug | targeted analgesia to ANI, usual practice |
Primary outcome
immediate maximum postoperative pain in recovery room defined by a score > 3 on a verbally administered numeric rating scale (NRS) variating from 0 to 10.
Time frame: From day 0 to day 28
Once the patient transferred to the recovery room, the assessment of the primary outcome (verbally administered NRS) will be done by the nurse responsible for the patient, when the patient arrives, during the stay and when the patient leaves the recovery room
11 secondary outcomes
Maximum pain score during the first postoperative day (numeric rating scale variating from 0 to 10).
Time frame: every 6 hours during the 24 first hours.
Score Postoperative D1 Pain Management (numeric rating scale variating from 0 to 10)
Time frame: At day 1
dose of morphine in the recovery room
Time frame: At day 0
postoperative nausea and vomiting in the recovery room
Time frame: At day 1
total dose of morphine during the first postoperative day (mg)
Time frame: At day 1
regional anesthesia for postoperative analgesic purposes
Time frame: At day 1
the duration in the recovery room (time to obtain an Aldrete score ≥9) (min)
Time frame: From day 0 to day 28
destination of the patient after surgery (unit of surgery, continuous care, resuscitation).
Time frame: From day 0 to day 28
incidence of postoperative complications on the first and seventh postoperative days for hospitalized patients using Post-Operative Morbidity Survey (POMS).
Time frame: From day 0 to day 1 and until day 7
duration of the hospitalization (day)
Time frame: From day 0 to day 28
Mortality at Day 28
Time frame: At day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Derived from this study: PubMed 35468803Michalot A, Bazin JE, Richebe P, Allaouchiche B, Boselli E. Effect of GOAL-Directed ANalgesia using ANI (Analgesia/Nociception Index) during general anesthesia on immediate postoperative pain and intraoperative hemodynamics in adult patients (GOALDAN study): a study protocol for randomized, controlled, multicenter trial. Trials. 2022 Apr 25;23(1):353. doi: 10.1186/s13063-022-06273-1.
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.
Jean-Etienne BAZIN principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anesthesic agent guided by ANI (Interventional Group) and Administration of the lowest effective concentration of desflurane (Interventional Group) in people with Immediate Severe Postoperative Pain and Perioperative Hemodynamic, run by University Hospital, Clermont-Ferrand 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 5 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 7 Jul 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (04 73 75 49 63, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immediate maximum postoperative pain in recovery room defined by a score > 3 on a verbally administered numeric rating scale (NRS) variating from 0 to 10. (time frame: From day 0 to day 28). 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 NCT03618082, 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 7 Jul 2020.