Major Abdominal SurgeryPHOENIXNCT03166644
Individualized Goal-directed Sufentanil Administration Versus Standard Therapy in Patients Undergoing Major Abdominal Surgery
A study testing Analgesia Nociception Index (ANI)-guided sufentanil administration in people with Major Abdominal Surgery, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
To determine whether a treatment strategy targeting an individualized sufentanil administration based on the Analgesia Nociception Index (ANI) could reduce the total dose of sufentanil during major abdominal surgery, as compared with standard practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Abdominal Surgery
- What is being tested?
- Analgesia Nociception Index (ANI)-guided sufentanil administration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jul 2017to 20 Jan 2019
- 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
- Age >18 years
- Elective major abdominal surgery
- Estimated duration of surgery greater than 2 hours
Who cannot join
- Emergency abdominal surgery
- Atrial fibrillation
- Patient with pacemaker
- Patient with heart transplant
- Chronic beta-blockade
- Intrathecal anesthesia
Show all 13Show fewer
- Conditions affecting SpO2 measurement (e.g., methemoglobinemia)
- Morbid obesity (BMI> 35 kg/m2)
- Obstructive sleep apnea (OSA)
- Person under legal guardianship or curatorship
- No affiliation with the French health care system
- Pregnant or breastfeeding women
- Refusal to participate or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individualized Goal-directed Sufentanil Administration Versus Standard Therapy in Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Feasibility Trial.
To determine whether a treatment strategy targeting an individualized sufentanil administration based on the Analgesia Nociception Index (ANI) could reduce the total dose of sufentanil during major abdominal surgery, as compared with standard practice.
Read the detailed description
Postoperative respiratory complications are the second most frequent complications after surgery, and a major burden in health care. Postoperative hypoxemia, which is one of the most meaningful factors associated with poor patient outcomes, is common after general anesthesia with rates as high as 30-50% in patients after abdominal surgery, even among those undergoing uneventful procedures.
Risk factors for early postoperative hypoxemia, whether modifiable or not, are mainly related to the patient condition, the surgical procedure and the intraoperative anesthesia management strategy, especially the detrimental effects resulting from potential residual effects of anesthetic agents. There is, to date, only limited data on the incidence of postoperative hypoxemia resulting from excessive intraoperative opioid administration.
The Analgesia Nociception Index (ANI) is a unit-less index ranging from 0 to 100 calculated from the instantaneous wavelet transform analysis of heart rate variability, which indirectly reflects the parasympathetic tone, with higher ANI values indicating a prominent parasympathetic tone. ANI is sensitive to nociception stimuli and has recently been proposed to evaluate the analgesia/nociception equilibrium. The few interventional studies that have investigated the ability of a protocol-driven intraoperative analgesia procedure to reduce postoperative pain have used mixed results. One recent observational study showed that ANI-guided remifentanil administration during vascular surgery resulted in low opioid consumption and low postoperative pain rates. In addition, to our knowledge, no study has investigated whether ANI monitoring can be used to improve postoperative outcome. Accordingly, to determine the impact of an ANI-guided individualized opioids administration on postoperative outcomes, a large multicenter randomized controlled trial is needed. However, before such a trial can take place, it is necessary to determine the feasibility in potential participating sites of successfully reducing intraoperative opioid consumption while reducing postoperative pain.
The purpose of this study was to examine the feasibility of undertaking such a trial. Our primary hypothesis is that individualizing sufentanil administration to target ANI values between 50 and 70 during major abdominal surgery could reduce the intraoperative dose of sufentanil, as compared with standard practice.
- Conditions
- Major Abdominal Surgery
- Being tested
- Analgesia Nociception Index (ANI)-guided sufentanil administration
- Keywords
- Analgesia Nociception Index (ANI), Postoperative Analgesia, Postoperative Hypoxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesia Nociception Index (ANI)-guided sufentanil administrationDevice
One recent observational study showed that ANI-guided remifentanil administration during vascular surgery resulted in low opioid consumption and low postoperative pain rates.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Patients with major abdominal surgery Receives: Device: Analgesia Nociception Index (ANI)-guided sufentanil administration |
| Intervention Group | Experimental | Patients with standard practice Receives: Device: Analgesia Nociception Index (ANI)-guided sufentanil administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose of sufentanil administered during major abdominal surgery
Measured: at day 0
Secondary outcomes (9)
Percentage of time spent in the therapeutic target
(ANI between 50 and 70 for an energy between 0.05 and 2.5)
Measured: at day 0
Number of patients with early postoperative hypoxemia
(defined as SpO2 <94% in ambient air but responding to administration of oxygen by nasal cannula or facial mask)
Measured: at 30 min, 1 hour, 2 hour and 3 hour after tracheal extubation
Number of patients with late postoperative hypoxemia
(defined as SpO2 <94% in ambient air but responding to administration of oxygen by nasal cannula or facial mask)
Measured: at day 1 and 2 after surgery
Time to extubation
Measured: at day 0
Need for postoperative oxygen therapy
Measured: at day 0
Postoperative pain score
evaluated by a visual numeric scale (EVN) at rest and after exercise
Measured: at 30 min, 1 hour, 2 hour and 3 hour after extubation
Postoperative pain score
evaluated by a visual numeric scale (EVN) at rest and after exercise
Measured: on postoperative Day 1 and Day 2
Total dose of morphine administered in postoperative care unit
PACU
Measured: at day 1
Duration of PACU stay
defined by the time interval to reach an Aldrete score of 9 or more after the end of sufentanil administration
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start4 Jul 2017
- Primary completion20 Jan 2019
- Study completion20 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants receive an intervention throughout the protocol
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Rennes University Hospital, University Hospital, Montpellier
- Responsible party
- Sponsor
- Investigators
- Emmanuel FUTIER, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166644
- Sponsor's protocol ID
- CHU-335
- Other IDs
- 2016-001603-23, 2016
- Acronym
- PHOENIX
- Status last verified
- Aug 2019
- First submitted
- 23 May 2017
- Last updated
- 16 Oct 2023
- 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 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Goal-directed Sufentanil Administration Versus Standard Therapy in Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Feasibility Trial.
- ClinicalTrials.gov ID
- NCT03166644
- Acronym / sponsor ID
- PHOENIX / CHU-335
- Conditions
- Major Abdominal Surgery
- Keywords
- Analgesia Nociception Index (ANI), Postoperative Analgesia, Postoperative Hypoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Rennes University Hospital, University Hospital, Montpellier
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 20 Jan 2019 (actual)
- Study completion
- 20 Jan 2019 (actual)
- First posted
- 25 May 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.
To determine whether a treatment strategy targeting an individualized sufentanil administration based on the Analgesia Nociception Index (ANI) could reduce the total dose of sufentanil during major abdominal surgery, as compared with standard practice.
Detailed description
Postoperative respiratory complications are the second most frequent complications after surgery, and a major burden in health care. Postoperative hypoxemia, which is one of the most meaningful factors associated with poor patient outcomes, is common after general anesthesia with rates as high as 30-50% in patients after abdominal surgery, even among those undergoing uneventful procedures.
Risk factors for early postoperative hypoxemia, whether modifiable or not, are mainly related to the patient condition, the surgical procedure and the intraoperative anesthesia management strategy, especially the detrimental effects resulting from potential residual effects of anesthetic agents. There is, to date, only limited data on the incidence of postoperative hypoxemia resulting from excessive intraoperative opioid administration.
The Analgesia Nociception Index (ANI) is a unit-less index ranging from 0 to 100 calculated from the instantaneous wavelet transform analysis of heart rate variability, which indirectly reflects the parasympathetic tone, with higher ANI values indicating a prominent parasympathetic tone. ANI is sensitive to nociception stimuli and has recently been proposed to evaluate the analgesia/nociception equilibrium. The few interventional studies that have investigated the ability of a protocol-driven intraoperative analgesia procedure to reduce postoperative pain have used mixed results. One recent observational study showed that ANI-guided remifentanil administration during vascular surgery resulted in low opioid consumption and low postoperative pain rates. In addition, to our knowledge, no study has investigated whether ANI monitoring can be used to improve postoperative outcome. Accordingly, to determine the impact of an ANI-guided individualized opioids administration on postoperative outcomes, a large multicenter randomized controlled trial is needed. However, before such a trial can take place, it is necessary to determine the feasibility in potential participating sites of successfully reducing intraoperative opioid consumption while reducing postoperative pain.
The purpose of this study was to examine the feasibility of undertaking such a trial. Our primary hypothesis is that individualizing sufentanil administration to target ANI values between 50 and 70 during major abdominal surgery could reduce the intraoperative dose of sufentanil, as compared with standard practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants receive an intervention throughout the protocol
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Device: Analgesia Nociception Index (ANI)-guided sufentanil administrationPatients with major abdominal surgery |
| Intervention Group | Experimental | Device: Analgesia Nociception Index (ANI)-guided sufentanil administrationPatients with standard practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Elective major abdominal surgery
- Estimated duration of surgery greater than 2 hours
Key exclusion criteria (13 listed)
- Emergency abdominal surgery
- Atrial fibrillation
- Patient with pacemaker
- Patient with heart transplant
- Chronic beta-blockade
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 Index (ANI)-guided sufentanil administrationOne recent observational study showed that ANI-guided remifentanil administration during vascular surgery resulted in low opioid consumption and low postoperative pain rates. | Device | Control Group, Intervention Group |
Primary outcome
Total dose of sufentanil administered during major abdominal surgery
Time frame: at day 0
9 secondary outcomes
Percentage of time spent in the therapeutic target
Time frame: at day 0
Number of patients with early postoperative hypoxemia
Time frame: at 30 min, 1 hour, 2 hour and 3 hour after tracheal extubation
Number of patients with late postoperative hypoxemia
Time frame: at day 1 and 2 after surgery
Time to extubation
Time frame: at day 0
Need for postoperative oxygen therapy
Time frame: at day 0
Postoperative pain score
Time frame: at 30 min, 1 hour, 2 hour and 3 hour after extubation
Postoperative pain score
Time frame: on postoperative Day 1 and Day 2
Total dose of morphine administered in postoperative care unit
Time frame: at day 1
Duration of PACU stay
Time frame: at day 1
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 16 Oct 2023.
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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.
Emmanuel FUTIER 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 study testing Analgesia Nociception Index (ANI)-guided sufentanil administration in people with Major Abdominal Surgery, 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 3 inclusion and 13 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 16 Oct 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 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?
Total dose of sufentanil administered during major abdominal surgery (time frame: at day 0). 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 16 Oct 2023.