PainPhase 4NCT02701478
ANI and NoL Index Variations After Standard Nociceptive Stimulus at 0, 50, 25 % of Inhaled N2O in the Anesthetic Mixture
A Phase 4 study testing N2O exposure in people with Pain, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
N2O has been used during general anesthesia (GA) for more than 100 years. It is known to have anesthetic agents sparing effect. But small is know on his real analgesic effect during GA. So far, the only way to monitor pain during GA was based on vital signs that are not specific and not sensitive. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain
- What is being tested?
- N2O exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Dec 2016
- Phase
- Phase 4
- 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
- ASA status I, II or III
- Patients aged 18 to 70 years
- Laparotomy for gynecological or bowel surgery
- Duration and type of surgery requiring an epidural analgesia via an epidural catheter placed prior the general anesthesia induction and an arterial line placed after induction of general anesthesia
Who cannot join
- When 100% O2 ventilation is required during anesthesia (except for the induction phase during which all the patients receive O2 100%).
- Patients having received intraocular injection of gas (such as SF6, C3F8, C2F6) within 3 months prior to the present surgery.
- Any condition where internal entrapped air could expand and become dangerous, such as:
- head injury within 6 months prior to surgery
- maxillofacial injuries within 6 months prior to surgery
- pneumothorax within 6 months prior to surgery
Show all 15Show fewer
- gas embolism within 6 months prior to surgery
- decompression sickness within 6 months prior to surgery
- bubbles of emphysema known for this patient
- middle ear, inner ear and sinus surgery
- major abdominal distension/occlusion and emergent surgery for intestinal obstruction
- if air has been injected into the epidural space to determine the placement of the needle for epidural anesthesia (only saline is used in our center for the loss of resistance technique to place the catheter into the epidural space)
- Any contra-indication or patient's refusal for epidural placement
- Unexpected difficult airway requesting excessive, possibly painful airway manipulations.
- Unexpected surgical complications requiring strong haemodynamic support (transfusions, volume challenges, vasopressors, inotropic drugs).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T2M4
Philippe Richebe, Md PhD, +195140743-6558, philipperichebe@live.com
Nadia Goding, RN, 514-252-3400 ext. 3193, ngodin.hmr@ssss.gouv.qc.ca
About this study
Official title: Assessment of the Intraoperative Analgesic Effect of 50%/50% N2O/O2 Inhalation by the Pain Index ANI Following a Standardized Electrical Stimulus in Patients Under Anesthesia. Comparison to the New NoL Analgesic Index.
N2O has been used during general anesthesia (GA) for more than 100 years. It is known to have anesthetic agents sparing effect. But small is know on his real analgesic effect during GA. So far, the only way to monitor pain during GA was based on vital signs that are not specific and not sensitive. Few devices tried to evaluated pain under GA during the last 2 decades. More recently, better devices were proposed such as the Physiodoloris device and the PMD200 device. The first offers an index called ANI based on heart rate variability (HRV) assessment. The second offers the NoL index based on the analysis of 5 parameters. The aim of the present study is to evaluate quantitatively the analgesic index of N2O during GA using the two indices ANI and NoL.
Read the detailed description
Title: Assessment of the intraoperative analgesic effect of 50%/50% Nitrous Oxide / Oxygen inhalation by the pain index ANI following a standardized electrical forearm stimulus in patients undergoing laparotomies under general anesthesia and with an intraoperative active epidural analgesia. Comparison to the new NoL analgesic index.
Objectives: To observe the variations of the intraoperative pain indexes ANI and NoL after a classical and standardized electrical stimulation of the forearm (applied with the commonly used nerve stimulator we use for muscle relaxation monitoring) at different concentrations of inhaled Nitrous Oxide (N2O) (from 0% to 50%, concentrations that are commonly used in daily anesthesia). This will allow a quantification of the analgesic effect of N2O.
Study Design: Prospective, open label, observational and descriptive study Subject Population: Adult patients scheduled to undergo abdominal surgery by laparotomy under general anesthesia with an active intraoperative epidural analgesia Sample Size: 40 patients will be evaluated in this study Study Duration: 1 year Study Center: Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada Adverse Events: None expected
- Conditions
- Pain
- Being tested
- N2O exposure
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N2O exposureDrug
Also called N2O
The aim of this study is to evaluate the nociceptive response to a standardized forearm electrical stimulus applied to patients under GA, during surgery, at different End-Tidal concentrations of N2O (ET-N2O: 0%-50%-25%-0%), and to see if ANI and NoL indices show less pain when inhaled N2O is higher.
| Study group | Role | What they receive |
|---|---|---|
| N2O exposure | Other | There is only one arm in this study. All patients under General Anesthesia are exposed to 4 different doses or concentrations of inhaled N2O that is combined with the anesthetic desflurane. Each patient will be submitted to the standard nociceptive stimulus when inhaled N2O is at 0, 50, 25, and finally back to 0%. ANI and NoL Indices variations between "before stimulus" and "after stimulus" at each N2O concentration will be assessed and compared. This will allow to demonstrate an analgesic effect (less variations of ANI and NoL) when inhaled N2O is high (50%) testifying for the analgesic effect of this gas N2O. Receives: Drug: N2O exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
ANI variation after stimulation in patients under GA at End-Tidal N2O 0% and 50%.
The same patient is anesthetized without N2O in the gas mixture first. The first standard stimulus is applied on the forearm of the patient when the N2O concentration in the anesthesia mixture is at 0%. ANI response to the stimulus is recorded. Then N2O is slowly increased to reached et-N2O 50% in the anesthesia mixture. Then, at ET-N2O 50%, the same standard stimulus is applied and ANI variations registered.
Measured: First stimulus is applied when the patient breaths 0% N2O in his anesthesia mixture. Second stimulus is applied at 50% End-Tidal N2O in the anesthesia mixture during the surgery.
Secondary outcomes (2)
NoL index variation after electrical stimulation in patients under GA atEnd-Tidal N2O 0% and 50%.
The same patient is anesthetized without N2O in the gas mixture first. The first standard stimulus is applied on the forearm of the patient when the N2O concentration in the anesthesia mixture is at 0%. NoL response to the stimulus is recorded. Then N2O is slowly increased to reached et-N2O 50% in the anesthesia mixture. Then, at ET-N2O 50%, the same standard stimulus is applied and NoL variations registered.
Measured: First stimulus is applied when the patient breaths 0% N2O in his anesthesia mixture. Second stimulus is applied at 50% End-Tidal N2O in the anesthesia mixture during the surgery.
ANI and NoL indices variations after the same standard stimulus when ET-N2O is slowly decreased from 50% to 25%, , then to 0%.
During the surgery, for primary and secondary objectives, N2O will be at 0, then 50%.
For these secondary objectives, N2O inhaled concentration in teh anesthetic mixture will be set at 25% and then again at 0% and the same standard stimulus will be applied and ANI and NoL responses recorded and compared to the ones gotten at 50% .
Measured: Within the same anesthesia and surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
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 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Richebé, Maisonneuve-Rosemont Hospital
- Investigators
- Philippe Richebe, MD PhD, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701478
- Sponsor's protocol ID
- 15064
- Status last verified
- Nov 2016
- First submitted
- 2 Mar 2016
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Coulombe MA, Decary E, Maximos S, Brulotte V, Drolet P, Tanoubi I, Issa R, Zaphiratos V, Verdonck O, Fortier LP, Godin N, Idrissi M, Raft J, Richebe P. Assessing the antinociceptive effect of nitrous oxide to tetanic stimulation in anaesthetised patients with new intra-operative nociception monitors: An observational study. Eur J Anaesthesiol. 2021 May 1;38(5):512-523. doi: 10.1097/EJA.0000000000001431.
PubMed 33399383
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
- Assessment of the Intraoperative Analgesic Effect of 50%/50% N2O/O2 Inhalation by the Pain Index ANI Following a Standardized Electrical Stimulus in Patients Under Anesthesia. Comparison to the New NoL Analgesic Index.
- ClinicalTrials.gov ID
- NCT02701478
- Acronym / sponsor ID
- 15064
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 Mar 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.
N2O has been used during general anesthesia (GA) for more than 100 years. It is known to have anesthetic agents sparing effect. But small is know on his real analgesic effect during GA. So far, the only way to monitor pain during GA was based on vital signs that are not specific and not sensitive. Few devices tried to evaluated pain under GA during the last 2 decades. More recently, better devices were proposed such as the Physiodoloris device and the PMD200 device. The first offers an index called ANI based on heart rate variability (HRV) assessment. The second offers the NoL index based on the analysis of 5 parameters. The aim of the present study is to evaluate quantitatively the analgesic index of N2O during GA using the two indices ANI and NoL.
Detailed description
Title: Assessment of the intraoperative analgesic effect of 50%/50% Nitrous Oxide / Oxygen inhalation by the pain index ANI following a standardized electrical forearm stimulus in patients undergoing laparotomies under general anesthesia and with an intraoperative active epidural analgesia. Comparison to the new NoL analgesic index.
Objectives: To observe the variations of the intraoperative pain indexes ANI and NoL after a classical and standardized electrical stimulation of the forearm (applied with the commonly used nerve stimulator we use for muscle relaxation monitoring) at different concentrations of inhaled Nitrous Oxide (N2O) (from 0% to 50%, concentrations that are commonly used in daily anesthesia). This will allow a quantification of the analgesic effect of N2O.
Study Design: Prospective, open label, observational and descriptive study Subject Population: Adult patients scheduled to undergo abdominal surgery by laparotomy under general anesthesia with an active intraoperative epidural analgesia Sample Size: 40 patients will be evaluated in this study Study Duration: 1 year Study Center: Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada Adverse Events: None expected
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N2O exposure | Other | Drug: N2O exposureThere is only one arm in this study. All patients under General Anesthesia are exposed to 4 different doses or concentrations of inhaled N2O that is combined with the anesthetic desflurane. Each patient will be submitted to the standard nociceptive stimulus when inhaled N2O is at 0, 50, 25, and finally back to 0%. ANI and NoL Indices variations between "before stimulus" and "after stimulus" at each N2O concentration will be assessed and compared. This will allow to demonstrate an analgesic effect (less variations of ANI and NoL) when inhaled N2O is high (50%) testifying for the analgesic effect of this gas N2O. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA status I, II or III
- Patients aged 18 to 70 years
- Laparotomy for gynecological or bowel surgery
- Duration and type of surgery requiring an epidural analgesia via an epidural catheter placed prior the general anesthesia induction and an arterial line placed after induction of general anesthesia
Key exclusion criteria (15 listed)
- When 100% O2 ventilation is required during anesthesia (except for the induction phase during which all the patients receive O2 100%).
- Patients having received intraocular injection of gas (such as SF6, C3F8, C2F6) within 3 months prior to the present surgery.
- Any condition where internal entrapped air could expand and become dangerous, such as:
- Any contra-indication or patient's refusal for epidural placement
- Unexpected difficult airway requesting excessive, possibly painful airway manipulations.
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 |
|---|---|---|
| N2O exposureAlso: N2OThe aim of this study is to evaluate the nociceptive response to a standardized forearm electrical stimulus applied to patients under GA, during surgery, at different End-Tidal concentrations of N2O (ET-N2O: 0%-50%-25%-0%), and to see if ANI and NoL indices show less pain when inhaled N2O is higher. | Drug | N2O exposure |
Primary outcome
ANI variation after stimulation in patients under GA at End-Tidal N2O 0% and 50%.
Time frame: First stimulus is applied when the patient breaths 0% N2O in his anesthesia mixture. Second stimulus is applied at 50% End-Tidal N2O in the anesthesia mixture during the surgery.
The same patient is anesthetized without N2O in the gas mixture first. The first standard stimulus is applied on the forearm of the patient when the N2O concentration in the anesthesia mixture is at 0%. ANI response to the stimulus is recorded. Then N2O is slowly increased to reached et-N2O 50% in the anesthesia mixture. Then, at ET-N2O 50%, the same standard stimulus is applied and ANI variations registered.
2 secondary outcomes
NoL index variation after electrical stimulation in patients under GA atEnd-Tidal N2O 0% and 50%.
Time frame: First stimulus is applied when the patient breaths 0% N2O in his anesthesia mixture. Second stimulus is applied at 50% End-Tidal N2O in the anesthesia mixture during the surgery.
ANI and NoL indices variations after the same standard stimulus when ET-N2O is slowly decreased from 50% to 25%, , then to 0%.
Time frame: Within the same anesthesia and surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
- Derived from this study: PubMed 33399383Coulombe MA, Decary E, Maximos S, Brulotte V, Drolet P, Tanoubi I, Issa R, Zaphiratos V, Verdonck O, Fortier LP, Godin N, Idrissi M, Raft J, Richebe P. Assessing the antinociceptive effect of nitrous oxide to tetanic stimulation in anaesthetised patients with new intra-operative nociception monitors: An observational study. Eur J Anaesthesiol. 2021 May 1;38(5):512-523. doi: 10.1097/EJA.0000000000001431.
- 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.
Philippe Richebe, MD 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?
A Phase 4 study testing N2O exposure in people with 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 4 inclusion and 15 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: status not confirmed, 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Richebe, MD PhD (+1-514-743-6558, philipperichebe@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ANI variation after stimulation in patients under GA at End-Tidal N2O 0% and 50%. (time frame: First stimulus is applied when the patient breaths 0% N2O in his anesthesia mixture. Second stimulus is applied at 50% End-Tidal N2O in the anesthesia mixture during the 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 NCT02701478, 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 18 Nov 2016.