PainNCT02602379
Evaluation of NoL Index and ANI After Nociceptive Stimulation at Different Infusion Rates of Remifentanil Infusion
An observational study of Pain, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
Contrary to "immobility" and, to a lesser extent, to the "hypnosis/unconsciousness" component of general anaesthesia, the monitoring of "analgesia" remains largely elusive, evaluated mainly through poorly sensitive and potentially undesirable changes in patients' vital signs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Tetanic stimulation
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Jul 2015
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective abdominal surgery by laparotomy (general surgery or gynaecological surgery) who will receive a thoracic epidural (around T9-T10/T10-T11) and general anesthesia.
Who may be able to join
- ASA status I, II or III
- Elective abdominal surgery with median laparotomy under general anaesthesia and epidural analgesia.
Who cannot join
- Coronary artery disease
- Serious cardiac arrhythmias (including atrial fibrillation)
- Patient refusal
- History of substance abuse
- Chronic use of psychotropic and/or opioid drugs
- Use of drugs that act on the autonomic nervous system (including β-blockers)
Show all 13Show fewer
- History of psychiatric diseases or psychological problems
- Contraindications to epidural analgesia
- Allergy to remifentanil
- Unexpected difficult airway requesting excessive, possibly painful airway manipulations.
- Dural puncture during epidural catheter installation
- Failure of epidural analgesia
- Surgical unexpected complications requiring strong haemodynamic support (transfusions, vasopressors, inotropes)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of NoL Index and ANI Variations After Nociceptive Stimulation Under Different Rates of Infusion of Intravenous Remifentanil in Patients Undergoing Laparotomies With Intraoperative Epidural Analgesia
Contrary to "immobility" and, to a lesser extent, to the "hypnosis/unconsciousness" component of general anaesthesia, the monitoring of "analgesia" remains largely elusive, evaluated mainly through poorly sensitive and potentially undesirable changes in patients' vital signs. This has led the industry to pursue the development of various devices and indices based on other physiological parameters such as heart rate variability (HRV), electroencephalogram (EEG), skin conductance, to name only a few. To the best of the knowledge, none of these parameters on its own has shown sufficient capacity in detecting different degrees of pain/analgesia balance to gain wide clinical use.
The purpose of this prospective observational study is to evaluate the response of a single-parameter index (the Analgesia Nociception Index [ANI]) and a multi-parameter index (the Nociception Level [NoL] Index) when patients under combined general anaesthesia/epidural anaesthesia for laparotomies are subjected to a standardized painful stimulus (a tetanic stimulation over the ulnar nerve at 70 mA, 100 Hz for 30 seconds) at different doses of remifentanil infusion at steady state (0,005 mcg/kg/min; 0,05 mcg/kg/min; 0,1 mcg/kg/min; 0,15 mcg/kg/min). With the painful stimulus held constant but the analgesia provided gradually increased, it is expected to characterize the response of these two indices to different levels of nociception/anti-nociception balance.
Read the detailed description
Patients scheduled for elective abdominal surgery by laparotomy (general surgery or gynaecological surgery) will receive a thoracic epidural (around T9-T10/T10-T11) and general anesthesia. Apart from standard monitoring, the ANI (derived from the EKG) and the NoL index (obtained via a finger probe) will be recorded. The epidural catheter will be injected with 6-10 ml of lidocaine 2% with epinephrine 5 mcg/ml to produce anesthetic level of neuraxial blocade and then be perfused with the same solution at 4-8 ml/hour. After incision and confirmation of adequate blocade with the epidural local anesthetic, the patient will receive a series of painful electric stimulation with a standard nerve stimulator applied over the ulnar nerve in tetanic mode for 30 seconds at 100 Hz and 70mA. Each stimulation will occur at a different rate of infusion of IV remifentanil at steady state (0,005 mcg/kg/min; 0,05 mcg/kg/min; 0,1 mcg/kg/min; 0,15 mcg/kg/min). A stimulation at 0,005 mcg/kg/min will be done before and after epidural loading with local anesthetics to look for altered variations in analysed parameters. The variation and the kinetic of the variations after stimulations will be observed for heart rate, mean blood pressure, BIS, ANI and NoL index.
- Conditions
- Pain
- Being tested
- Tetanic stimulation
- Keywords
- Pain, Monitoring, Analgesia Nociception Index, NoL, Nociception Level, Remifentanil
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanic stimulationOther
Standard Tetanic stimulation will be used as the stimulus to evaluate responses of the intraoperative pain indexes (ANI and NoL) at different concentration of i.v. remifentanil during anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Tetanic stimulation | Single arm study. See Study description for a through description of the intervention. Receives: Other: Tetanic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between NoL index responses to electrical stimulus and the i.v. doses of remifentanil infusion given during anesthesia. The n of patients (40 in this study) is calculated on this primary outcome.
The electrical stimulus will be applied on the forearm of the asleep patient at different doses of iv remifentanil (0.005mcg/kg/min to a maximum of 0.15 mcg/kg.min during anesthesia for abdominal surgery with active intraoperative epidural pain management). It will be evaluated whether or not exists a correlation between the doses of iv remifentanil and the responses of the Nol index after electrical stimulus.
Measured: At time of surgery
Secondary outcomes (5)
NoL index changes after a standardized electrical stimulus at 4 different concentrations of iv remifentanil infusion
Measure the NoL changes after a nociceptive stimulus at various intravenous remifentanil infusion doses.
Measured: At time of surgery
ANI index changes after a standardized electrical stimulus at 4 different concentrations of iv remifentanil infusion
Measure the ANI changes after a nociceptive stimulus at various intravenous remifentanil infusion doses. ANI being another uniparametric pain index.
Measured: At time of surgery
Heart rate changes after a standardized electrical stimulus at 4 different concentrations of iv remifentanil infusion
Measure the changes of Heart Rate after a nociceptive stimulus at various intravenous remifentanil infusion doses.
Measured: At time of surgery
Mean Blood Pressure changes after a standardized electrical stimulus at 4 different concentrations of iv remifentanil infusion
Measure the changes of Heart Rate after a nociceptive stimulus at various intravenous remifentanil infusion doses.
Measured: At time of surgery
Sensitivity and specificity of NoL index, ANI index, Heart Rate and Mean blood Pressure in detecting a painful stimulus such as intubation as well as standardized electrical stimulus at remifentanil infusion of 0.005 msg/kg/min
Measure the sensitivity and specificity of these 4 criteria in detecting a painful stimulus such as intubation and standardized electrical stimulus
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medasense Biometrics Ltd
- Responsible party
- Principal investigator, Philippe Richebé, Maisonneuve-Rosemont Hospital
- Investigators
- Philippe Richebé, M.D. PhD, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602379
- Sponsor's protocol ID
- HMR14090
- Status last verified
- Nov 2016
- First submitted
- 25 Oct 2015
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of NoL Index and ANI Variations After Nociceptive Stimulation Under Different Rates of Infusion of Intravenous Remifentanil in Patients Undergoing Laparotomies With Intraoperative Epidural Analgesia
- ClinicalTrials.gov ID
- NCT02602379
- Acronym / sponsor ID
- HMR14090
- Conditions
- Pain
- Keywords
- Pain, Monitoring, Analgesia Nociception Index, NoL, Nociception Level, Remifentanil
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Collaborators
- Medasense Biometrics Ltd
- Study start
- Feb 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 11 Nov 2015 (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.
Contrary to "immobility" and, to a lesser extent, to the "hypnosis/unconsciousness" component of general anaesthesia, the monitoring of "analgesia" remains largely elusive, evaluated mainly through poorly sensitive and potentially undesirable changes in patients' vital signs. This has led the industry to pursue the development of various devices and indices based on other physiological parameters such as heart rate variability (HRV), electroencephalogram (EEG), skin conductance, to name only a few. To the best of the knowledge, none of these parameters on its own has shown sufficient capacity in detecting different degrees of pain/analgesia balance to gain wide clinical use.
The purpose of this prospective observational study is to evaluate the response of a single-parameter index (the Analgesia Nociception Index [ANI]) and a multi-parameter index (the Nociception Level [NoL] Index) when patients under combined general anaesthesia/epidural anaesthesia for laparotomies are subjected to a standardized painful stimulus (a tetanic stimulation over the ulnar nerve at 70 mA, 100 Hz for 30 seconds) at different doses of remifentanil infusion at steady state (0,005 mcg/kg/min; 0,05 mcg/kg/min; 0,1 mcg/kg/min; 0,15 mcg/kg/min). With the painful stimulus held constant but the analgesia provided gradually increased, it is expected to characterize the response of these two indices to different levels of nociception/anti-nociception balance.
Detailed description
Patients scheduled for elective abdominal surgery by laparotomy (general surgery or gynaecological surgery) will receive a thoracic epidural (around T9-T10/T10-T11) and general anesthesia. Apart from standard monitoring, the ANI (derived from the EKG) and the NoL index (obtained via a finger probe) will be recorded. The epidural catheter will be injected with 6-10 ml of lidocaine 2% with epinephrine 5 mcg/ml to produce anesthetic level of neuraxial blocade and then be perfused with the same solution at 4-8 ml/hour. After incision and confirmation of adequate blocade with the epidural local anesthetic, the patient will receive a series of painful electric stimulation with a standard nerve stimulator applied over the ulnar nerve in tetanic mode for 30 seconds at 100 Hz and 70mA. Each stimulation will occur at a different rate of infusion of IV remifentanil at steady state (0,005 mcg/kg/min; 0,05 mcg/kg/min; 0,1 mcg/kg/min; 0,15 mcg/kg/min). A stimulation at 0,005 mcg/kg/min will be done before and after epidural loading with local anesthetics to look for altered variations in analysed parameters. The variation and the kinetic of the variations after stimulations will be observed for heart rate, mean blood pressure, BIS, ANI and NoL index.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tetanic stimulation | – | Other: Tetanic stimulationSingle arm study. See Study description for a through description of the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective abdominal surgery by laparotomy (general surgery or gynaecological surgery) who will receive a thoracic epidural (around T9-T10/T10-T11) and general anesthesia.
Key inclusion criteria (2 listed)
- ASA status I, II or III
- Elective abdominal surgery with median laparotomy under general anaesthesia and epidural analgesia.
Key exclusion criteria (13 listed)
- Coronary artery disease
- Serious cardiac arrhythmias (including atrial fibrillation)
- Patient refusal
- History of substance abuse
- Chronic use of psychotropic and/or opioid drugs
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 |
|---|---|---|
| Tetanic stimulationStandard Tetanic stimulation will be used as the stimulus to evaluate responses of the intraoperative pain indexes (ANI and NoL) at different concentration of i.v. remifentanil during anesthesia. | Other | Tetanic stimulation |
Primary outcome
Correlation between NoL index responses to electrical stimulus and the i.v. doses of remifentanil infusion given during anesthesia. The n of patients (40 in this study) is calculated on this primary outcome.
Time frame: At time of surgery
The electrical stimulus will be applied on the forearm of the asleep patient at different doses of iv remifentanil (0.005mcg/kg/min to a maximum of 0.15 mcg/kg.min during anesthesia for abdominal surgery with active intraoperative epidural pain management). It will be evaluated whether or not exists a correlation between the doses of iv remifentanil and the responses of the Nol index after electrical stimulus.
5 secondary outcomes
NoL index changes after a standardized electrical stimulus at 4 different concentrations of iv remifentanil infusion
Time frame: At time of surgery
ANI index changes after a standardized electrical stimulus at 4 different concentrations of iv remifentanil infusion
Time frame: At time of surgery
Heart rate changes after a standardized electrical stimulus at 4 different concentrations of iv remifentanil infusion
Time frame: At time of surgery
Mean Blood Pressure changes after a standardized electrical stimulus at 4 different concentrations of iv remifentanil infusion
Time frame: At time of surgery
Sensitivity and specificity of NoL index, ANI index, Heart Rate and Mean blood Pressure in detecting a painful stimulus such as intubation as well as standardized electrical stimulus at remifentanil infusion of 0.005 msg/kg/min
Time frame: At time of surgery
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 18 Nov 2016.
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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.
Philippe Richebé, M.D. PhD principal investigator
Maisonneuve-Rosemont Hospital
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, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
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 2 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 18 Nov 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 Canada. 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?
Correlation between NoL index responses to electrical stimulus and the i.v. doses of remifentanil infusion given during anesthesia. The n of patients (40 in this study) is calculated on this primary outcome. (time frame: At time of surgery). 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 18 Nov 2016.