AnesthesiaNCT01839513
Prediction of Hemodynamic Reactivity During General Anesthesia Using Analgesia/Nociception Index (ANI)
An observational study of Anesthesia, run by Hôpital Edouard Herriot at 1 site in France.
Trial summary
The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the prediction of hemodynamic reactivity in adult patients undergoing ear-nose-throat or lower limb orthopedic surgery on desflurane/remifentanil general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Nov 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients underoing ear-nose-throat or orthopedic lower limb surgery performed on desflurane/remifentanil general anesthesia
Who may be able to join
- Age 18-75 years
- Ear-nose-throat or lower limb surgery
- General anesthesia using desflurane and remifentanil
Who cannot join
- Age <18 yrs or >75 yrs
- Arrythmia
- Preoperative use of B-blockers
- Administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes
- Psychiatric diseases
- Autonomic nervous system disorders (epilepsy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Hemodynamic Reactivity During Desflurane/Remifentanil General Anesthesia Using Analgesia/Nociception Index (ANI)
The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the prediction of hemodynamic reactivity in adult patients undergoing ear-nose-throat or lower limb orthopedic surgery on desflurane/remifentanil general anesthesia.
Read the detailed description
Measurement of analgesia/nociception index at different time points during procedure and assessment of analgesia/nociception index to predict hemodynamic reactivity by building receiver observer's characteristic curve.
- Conditions
- Anesthesia
- Keywords
- Analgesia/nociception index, Desflurane, Remifentanil, Orthopedic surgery, Ear-nose-throat surgery, Hemodynamic reactivity
- Medical subject headings
- Agnosia
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate and/or systolic blood pressure by more than 20% within 5 minutes
Measured: Before induction of anesthesia, 1 min after incision, at steady-state anesthesia during procedure (an expected average of 30 min) and at arousal from general anesthesia in the end of procedure (an expected average of 60 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2013
- Study completionNov 2013
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 AnesthesiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Edouard Herriot
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emmanuel Boselli, Hôpital Edouard Herriot
- Investigators
- Emmanuel Boselli, MD, PhD, Study director, Hôpital Edourd HerriotBernard Allaouchiche, MD, PhD, Study chair, Hôpital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839513
- Sponsor's protocol ID
- CPP 2013-021B
- Status last verified
- Nov 2013
- First submitted
- 22 Apr 2013
- Last updated
- 5 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boselli 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 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Hemodynamic Reactivity During Desflurane/Remifentanil General Anesthesia Using Analgesia/Nociception Index (ANI)
- ClinicalTrials.gov ID
- NCT01839513
- Acronym / sponsor ID
- CPP 2013-021B
- Conditions
- Anesthesia
- Keywords
- Analgesia/nociception index, Desflurane, Remifentanil, Orthopedic surgery, Ear-nose-throat surgery, Hemodynamic reactivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hôpital Edouard HerriotUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 Apr 2013 (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 aim of this study is to evaluate the performance of Analgesia/Nociception Index for the prediction of hemodynamic reactivity in adult patients undergoing ear-nose-throat or lower limb orthopedic surgery on desflurane/remifentanil general anesthesia.
Detailed description
Measurement of analgesia/nociception index at different time points during procedure and assessment of analgesia/nociception index to predict hemodynamic reactivity by building receiver observer's characteristic curve.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients underoing ear-nose-throat or orthopedic lower limb surgery performed on desflurane/remifentanil general anesthesia
Key inclusion criteria (3 listed)
- Age 18-75 years
- Ear-nose-throat or lower limb surgery
- General anesthesia using desflurane and remifentanil
Key exclusion criteria (6 listed)
- Age <18 yrs or >75 yrs
- Arrythmia
- Preoperative use of B-blockers
- Administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes
- Psychiatric diseases
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
Change in heart rate and/or systolic blood pressure by more than 20% within 5 minutes
Time frame: Before induction of anesthesia, 1 min after incision, at steady-state anesthesia during procedure (an expected average of 30 min) and at arousal from general anesthesia in the end of procedure (an expected average of 60 min)
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 5 Nov 2013.
- 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.
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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 Boselli, MD, PhD study director
Hôpital Edourd Herriot
Bernard Allaouchiche, MD, PhD study chair
Hôpital Edouard Herriot
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 Anesthesia, run by Hôpital Edouard Herriot 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 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 5 Nov 2013. 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 heart rate and/or systolic blood pressure by more than 20% within 5 minutes (time frame: Before induction of anesthesia, 1 min after incision, at steady-state anesthesia during procedure (an expected average of 30 min) and at arousal from general anesthesia in the end of procedure (an expected average of 60 min)). 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 NCT01839513, 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 5 Nov 2013.