HypovolemiaNCT02193412
Influence of Variations of Systemic Venous Return on Analgesia Nociception Index (ANI) During General Anaesthesia
A study testing noxious stimulus, change in operating table slope: head-down tilt position and change in operating table slope: head-up tilt position in people with Hypovolemia and Somatic Pain, run by University Hospital, Lille at 1 site in France.
Trial summary
The purpose of this study is to determine whether the value of analgesia nociception index (ANI) is influenced by variations of systemic venous return (cardiac preload) under general anaesthesia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypovolemia, Somatic Pain
- What is being tested?
- noxious stimulus, change in operating table slope: head-down tilt position and change in operating table slope: head-up tilt position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2015to 3 Oct 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- neurosurgical operation requiring invasive monitoring of arterial blood pressure
Who cannot join
- pacemaker, arrhythmia
- chronic medication with beta blocker
- possible disorder of autonomic nervous system: diabetes, alcoholism, chronic pain
- anticholinergic drug administration before measures
- intracranial hypertension
- no social security coverage
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether the value of analgesia nociception index (ANI) is influenced by variations of systemic venous return (cardiac preload) under general anaesthesia.
Read the detailed description
In the context of opioid sparing goal during general anaesthesia, the Analgesia nociception index (ANI) is an analgesia/nociception balance monitoring tool computed from high frequency heart rate variability analysis, and developed by MetroDoloris (Lille, France). Its sensitivity to detect noxious stimulus was studied in several studies. However, its specificity is not established in particular in the presence of factors influencing autonomic nervous system other than analgesia/nociception balance. In the context of anaesthesia, one of the most relevant factor is hypovolemia. This study aims to assess the effect of blood volume variations on ANI under general anaesthesia, independently of analgesia/nociception balance status. Variations of systemic venous return (SVR) (cardiac preload), which reflects blood volume status, will be induced by changes of operating table slope, from head-down tilt (Trendelenburg), with increased SVR, to head-up tilt position, with decreased SVR. Variations of SVR will be attested by changes in the arterial pulse pressure variation, a well-established indice of preload responsiveness in the mechanically ventilated anaesthetized patient.
- Conditions
- Hypovolemia, Somatic Pain
- Being tested
- noxious stimulus, change in operating table slope: head-down tilt position, change in operating table slope: head-up tilt position
- Keywords
- analgesia nociception index, heart rate variability, autonomic nervous system, specificity, systemic venous return, pulse pressure variation, Intraoperative Monitoring
- Medical subject headings
- Hypovolemia, Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noxious stimulusProcedure or surgery
standardized noxious stimulus with tetanic stimulation
change in operating table slope: head-down tilt positionProcedure or surgery
Also called Trendelenburg position
-30°
change in operating table slope: head-up tilt positionProcedure or surgery
+30°
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | 1. noxious stimulus
2. change in operating table slope: head-down tilt position
3. change in operating table slope: head-up tilt position Receives: Procedure: noxious stimulus; Procedure: change in operating table slope: head-down tilt position; Procedure: change in operating table slope: head-up tilt position |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in ANI between head-down tilt (Trendelenburg) position and head-up tilt position
Position -20° to +20°
Measured: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
Secondary outcomes (5)
change in ANI between horizontal position and head-down/head up tilt position
Position 0° to -20° Position +20° to 0°
Measured: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
change in pulse pressure variation between head-down tilt position and head-up tilt position
Position -20° to +20°
Measured: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
change in ANI induced by standardized noxious stimulus (tetanic stimulation)
ANI measurement following tetanus
Measured: during a 5sec-tetanic stimulation (measurement for 1-2 min, 2-5 min after initial measurements in basal conditions)
variations of low frequency variability of arterial blood pressure
Position 0° to -20° Position -20° to +20° Position +20° to 0°
Measured: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
change in pulse pressure variation between horizontal position and head-down/head up tilt position
Position 0° to -20° Position +20° to 0°
Measured: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study start4 Jan 2015
- Primary completion3 Oct 2017
- Study completion3 Oct 2017
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 HypovolemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoît Tavernier, Pr, Principal investigator, University Hospital, LilleDélégation à la Recherche Clinique et à l'Innovation (DRC), Study chair, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193412
- Sponsor's protocol ID
- 2013_13
- Other IDs
- 2013-A01645-40
- Status last verified
- Oct 2020
- First submitted
- 15 Jul 2014
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Lamer A, Jeanne M, Marcilly R, Kipnis E, Schiro J, Logier R, Tavernier B. Methodology to automatically detect abnormal values of vital parameters in anesthesia time-series: Proposal for an adaptable algorithm. Comput Methods Programs Biomed. 2016 Jun;129:160-71. doi: 10.1016/j.cmpb.2016.01.004. Epub 2016 Jan 14.
PubMed 26817405
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Variations of Systemic Venous Return on Analgesia Nociception Index (ANI) During General Anaesthesia
- ClinicalTrials.gov ID
- NCT02193412
- Acronym / sponsor ID
- 2013_13
- Conditions
- Hypovolemia, Somatic Pain
- Keywords
- analgesia nociception index, heart rate variability, autonomic nervous system, specificity, systemic venous return, pulse pressure variation, Intraoperative Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 4 Jan 2015 (actual)
- Primary completion
- 3 Oct 2017 (actual)
- Study completion
- 3 Oct 2017 (actual)
- First posted
- 17 Jul 2014 (estimated)
- 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 purpose of this study is to determine whether the value of analgesia nociception index (ANI) is influenced by variations of systemic venous return (cardiac preload) under general anaesthesia.
Detailed description
In the context of opioid sparing goal during general anaesthesia, the Analgesia nociception index (ANI) is an analgesia/nociception balance monitoring tool computed from high frequency heart rate variability analysis, and developed by MetroDoloris (Lille, France). Its sensitivity to detect noxious stimulus was studied in several studies. However, its specificity is not established in particular in the presence of factors influencing autonomic nervous system other than analgesia/nociception balance. In the context of anaesthesia, one of the most relevant factor is hypovolemia. This study aims to assess the effect of blood volume variations on ANI under general anaesthesia, independently of analgesia/nociception balance status. Variations of systemic venous return (SVR) (cardiac preload), which reflects blood volume status, will be induced by changes of operating table slope, from head-down tilt (Trendelenburg), with increased SVR, to head-up tilt position, with decreased SVR. Variations of SVR will be attested by changes in the arterial pulse pressure variation, a well-established indice of preload responsiveness in the mechanically ventilated anaesthetized patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Procedure: noxious stimulus, Procedure: change in operating table slope: head-down tilt position, Procedure: change in operating table slope: head-up tilt position1. noxious stimulus 2. change in operating table slope: head-down tilt position 3. change in operating table slope: head-up tilt position |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- neurosurgical operation requiring invasive monitoring of arterial blood pressure
Key exclusion criteria (7 listed)
- pacemaker, arrhythmia
- chronic medication with beta blocker
- possible disorder of autonomic nervous system: diabetes, alcoholism, chronic pain
- anticholinergic drug administration before measures
- intracranial hypertension
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 |
|---|---|---|
| noxious stimulusstandardized noxious stimulus with tetanic stimulation | Procedure or surgery | patients |
| change in operating table slope: head-down tilt positionAlso: Trendelenburg position-30° | Procedure or surgery | patients |
| change in operating table slope: head-up tilt position+30° | Procedure or surgery | patients |
Primary outcome
change in ANI between head-down tilt (Trendelenburg) position and head-up tilt position
Time frame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
Position -20° to +20°
5 secondary outcomes
change in ANI between horizontal position and head-down/head up tilt position
Time frame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
change in pulse pressure variation between head-down tilt position and head-up tilt position
Time frame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
change in ANI induced by standardized noxious stimulus (tetanic stimulation)
Time frame: during a 5sec-tetanic stimulation (measurement for 1-2 min, 2-5 min after initial measurements in basal conditions)
variations of low frequency variability of arterial blood pressure
Time frame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
change in pulse pressure variation between horizontal position and head-down/head up tilt position
Time frame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
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 22 Apr 2026.
- Results publication: PubMed 26817405Lamer A, Jeanne M, Marcilly R, Kipnis E, Schiro J, Logier R, Tavernier B. Methodology to automatically detect abnormal values of vital parameters in anesthesia time-series: Proposal for an adaptable algorithm. Comput Methods Programs Biomed. 2016 Jun;129:160-71. doi: 10.1016/j.cmpb.2016.01.004. Epub 2016 Jan 14.
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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.
Benoît Tavernier, Pr principal investigator
University Hospital, Lille
Délégation à la Recherche Clinique et à l'Innovation (DRC) study chair
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing noxious stimulus, change in operating table slope: head-down tilt position and change in operating table slope: head-up tilt position in people with Hypovolemia and Somatic Pain, run by University Hospital, Lille 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 1 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 22 Apr 2026. 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?
change in ANI between head-down tilt (Trendelenburg) position and head-up tilt position (time frame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)). 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 NCT02193412, 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 22 Apr 2026.