PainNCT02744573
Evaluation Of The Analgesia Nociception Index vs. Surgical Pleth Index Under General And Regional Anaesthesia
An observational study of Pain and Stress, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
There is a lack of sufficient analgesia monitoring apart from surrogate parameters. The analgesia nociception index (ANI) shall be evaluated under general and regional anaesthesia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Stress, Monitoring
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2011to Dec 2012
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total number of 45 patients ≥ 18 years with a body mass index (BMI) < 35 kg m-2 and an American Society of Anesthesiologists (ASA) status I-III scheduled for elective urology and gynaecology surgery in lithotomy position were randomized. Additionally, 15 volunteers served as a control group under no anaesthesia.
Who may be able to join
- ≥ 18 years
- Body mass index (BMI) < 35 kg m2
- American Society of Anesthesiologists (ASA) status I-III
- Elective urology and gynaecology surgery in lithotomy position
- 15 healthy volunteers were included in the study as a control group
Who cannot join
- Age < 18 years
- ASA status IV or higher
- BMI ≥ 35 kg m2
- Chronic heart rhythm disorders
- Implanted pacemakers
- Patients with a history of chronic pain and emergency surgery
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24105
About this study
Official title: Evaluation Of The Analgesia Nociception Index vs. Surgical Pleth Index Under General And Regional Anaesthesia And The Effect Of Posture. A Prospective Randomized Controlled Trial.
There is a lack of sufficient analgesia monitoring apart from surrogate parameters. The analgesia nociception index (ANI) shall be evaluated under general and regional anaesthesia.
Read the detailed description
While sophisticated haemodynamic monitoring as well as depth of neuromuscular block and sedation are established in daily clinical routine monitoring of analgesia remains poorly represented. The surgical pleth index (SPI) algorithm takes into account both central and peripheral sympathetic tone via the normalised heart beat interval and the plethysmographic pulse wave amplitude and has been described before. A more detailed investigation on the SPI and its behaviour under a posture maneuver shows the limitation of the device.
Another device developed calculates the "analgesia nociception index" (ANI) by heart rate variability and was launched into the market in 2010. However, the effect of posture - to our knowledge - has not yet been studied. The change of body positioning during surgery is regularly necessary in order to improve surgical access to anatomic structures. These alterations in positioning are known to be accompanied by changes in haemodynamic parameters.
The aim of this study was to evaluate the ANI in patients undergoing elective surgery in lithotomy position.
- Conditions
- Pain, Stress, Monitoring
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General Anaesthesia | ANI and SPI values under general anaesthesia | |
| Spinal Anaesthesia | ANI and SPI values under spinal anaesthesia | |
| Spinal Anaesthesia + Sedation | ANI and SPI values under spinal anesthesia in combination with sedation | |
| Control | ANI and SPI values under no anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
ANI vs. SPI
Evaluation of the ANI and comparison to SPI (same unit of measure, both ranging between 0-100, no dimension) in patients undergoing elective surgery in lithotomy position. Evaluation and change of ANI and SPI values at pre-defined timepoints: 1) Baseline, 2) before induction of anaesthesia, during 3) intubation or spinal punction, 4) posture maneuver, 5) skin incision 6) surgical suture, 7) post anesthetic care unit stay (arrival).
Measured: Data will be assessed and collected immediately after completion of each case of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startSep 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timo Iden, University Hospital Schleswig-Holstein
- Investigators
- Matthias Grünewald, MD, Principal investigator, Department of Anaesthesiology and Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744573
- Sponsor's protocol ID
- ANI_SPI
- Status last verified
- Apr 2016
- First submitted
- 14 Dec 2015
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Huiku M, Uutela K, van Gils M, Korhonen I, Kymalainen M, Merilainen P, Paloheimo M, Rantanen M, Takala P, Viertio-Oja H, Yli-Hankala A. Assessment of surgical stress during general anaesthesia. Br J Anaesth. 2007 Apr;98(4):447-55. doi: 10.1093/bja/aem004. Epub 2007 Feb 28.
PubMed 17329347Ilies C, Ludwigs J, Gruenewald M, Thee C, Hanf J, Hanss R, Steinfath M, Bein B. The effect of posture and anaesthetic technique on the surgical pleth index. Anaesthesia. 2012 May;67(5):508-513. doi: 10.1111/j.1365-2044.2011.07051.x. Epub 2012 Feb 11.
PubMed 22324319Boselli E, Daniela-Ionescu M, Begou G, Bouvet L, Dabouz R, Magnin C, Allaouchiche B. Prospective observational study of the non-invasive assessment of immediate postoperative pain using the analgesia/nociception index (ANI). Br J Anaesth. 2013 Sep;111(3):453-9. doi: 10.1093/bja/aet110. Epub 2013 Apr 16.
PubMed 23592690
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Analgesia Nociception Index vs. Surgical Pleth Index Under General And Regional Anaesthesia And The Effect Of Posture. A Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02744573
- Acronym / sponsor ID
- ANI_SPI
- Conditions
- Pain, Stress, Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Apr 2016 (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.
There is a lack of sufficient analgesia monitoring apart from surrogate parameters. The analgesia nociception index (ANI) shall be evaluated under general and regional anaesthesia.
Detailed description
While sophisticated haemodynamic monitoring as well as depth of neuromuscular block and sedation are established in daily clinical routine monitoring of analgesia remains poorly represented. The surgical pleth index (SPI) algorithm takes into account both central and peripheral sympathetic tone via the normalised heart beat interval and the plethysmographic pulse wave amplitude and has been described before. A more detailed investigation on the SPI and its behaviour under a posture maneuver shows the limitation of the device.
Another device developed calculates the "analgesia nociception index" (ANI) by heart rate variability and was launched into the market in 2010. However, the effect of posture - to our knowledge - has not yet been studied. The change of body positioning during surgery is regularly necessary in order to improve surgical access to anatomic structures. These alterations in positioning are known to be accompanied by changes in haemodynamic parameters.
The aim of this study was to evaluate the ANI in patients undergoing elective surgery in lithotomy position.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| General Anaesthesia | – | –ANI and SPI values under general anaesthesia |
| Spinal Anaesthesia | – | –ANI and SPI values under spinal anaesthesia |
| Spinal Anaesthesia + Sedation | – | –ANI and SPI values under spinal anesthesia in combination with sedation |
| Control | – | –ANI and SPI values under no anaesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total number of 45 patients ≥ 18 years with a body mass index (BMI) < 35 kg m-2 and an American Society of Anesthesiologists (ASA) status I-III scheduled for elective urology and gynaecology surgery in lithotomy position were randomized. Additionally, 15 volunteers served as a control group under no anaesthesia.
Key inclusion criteria (5 listed)
- ≥ 18 years
- Body mass index (BMI) < 35 kg m2
- American Society of Anesthesiologists (ASA) status I-III
- Elective urology and gynaecology surgery in lithotomy position
- 15 healthy volunteers were included in the study as a control group
Key exclusion criteria (6 listed)
- Age < 18 years
- ASA status IV or higher
- BMI ≥ 35 kg m2
- Chronic heart rhythm disorders
- Implanted pacemakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ANI vs. SPI
Time frame: Data will be assessed and collected immediately after completion of each case of surgery.
Evaluation of the ANI and comparison to SPI (same unit of measure, both ranging between 0-100, no dimension) in patients undergoing elective surgery in lithotomy position. Evaluation and change of ANI and SPI values at pre-defined timepoints: 1) Baseline, 2) before induction of anaesthesia, during 3) intubation or spinal punction, 4) posture maneuver, 5) skin incision 6) surgical suture, 7) post anesthetic care unit stay (arrival).
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 20 Apr 2016.
- Background: PubMed 17329347Huiku M, Uutela K, van Gils M, Korhonen I, Kymalainen M, Merilainen P, Paloheimo M, Rantanen M, Takala P, Viertio-Oja H, Yli-Hankala A. Assessment of surgical stress during general anaesthesia. Br J Anaesth. 2007 Apr;98(4):447-55. doi: 10.1093/bja/aem004. Epub 2007 Feb 28.
- Background: PubMed 22324319Ilies C, Ludwigs J, Gruenewald M, Thee C, Hanf J, Hanss R, Steinfath M, Bein B. The effect of posture and anaesthetic technique on the surgical pleth index. Anaesthesia. 2012 May;67(5):508-513. doi: 10.1111/j.1365-2044.2011.07051.x. Epub 2012 Feb 11.
- Background: PubMed 23592690Boselli E, Daniela-Ionescu M, Begou G, Bouvet L, Dabouz R, Magnin C, Allaouchiche B. Prospective observational study of the non-invasive assessment of immediate postoperative pain using the analgesia/nociception index (ANI). Br J Anaesth. 2013 Sep;111(3):453-9. doi: 10.1093/bja/aet110. Epub 2013 Apr 16.
- 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.
Matthias Grünewald, MD principal investigator
Department of Anaesthesiology and Intensive Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Stress, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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 6 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 20 Apr 2016. 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 Germany. 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?
ANI vs. SPI (time frame: Data will be assessed and collected immediately after completion of each case of surgery.). 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 NCT02744573, which also lists 3 linked publications.
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 20 Apr 2016.