Nociception During Anesthesia in Patients Taking β1-adrenergic Antagonist Chronic TreatmentBetaNOLNCT04060095
Impact of Chronic Treatment by β1-adrenergic Antagonists on Nociceptive-Level (NOL) Index Variation After a Standardized Noxious Stimulus Under General Anesthesia
An observational study of Nociception During Anesthesia in Patients Taking β1-adrenergic Antagonist Chronic Treatment, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
The aim of the present study is to investigate the effect of chronic treatment with β1-adrenergic antagonist on the NOL index variation, the heart rate variation and the mean blood pressure variation after a standardized noxious stimulus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nociception During Anesthesia in Patients Taking β1-adrenergic Antagonist Chronic Treatment
- What is being tested?
- standardized noxious stimulus under general anesthesia.
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- 27 Aug 2019to 4 Mar 2020
- 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: Enrollment of a total of 25 adult patients undergoing general anesthesia for elective surgery (full data analysis available for 25 patients; inclusion until this n is reached). This number was determined on two previous studies conducted at Maisonneuve-Rosemont on the NOL index reactivity to the same stimulus and under the same anesthesia conditions and published in 2018 (Stockle PA et al. Minerva Anestesiologica) and 2019 (Renaud-Roy et al. CJA) from which we got full data from 25 patients who were not chronically treated by β1-adrenergic antagonists. We will compare this previous cohort to the new prospective cohort of patients chronically treated with β1-adrenergic antagonists.
Who may be able to join
- Patient age > 18 years
- ASA I-III
- Adult patients scheduled to undergo elective surgery under general anesthesia
- Patients chronically treated with β1-adrenergic antagonists for at least three months prior to surgery
- Patient able to consent in the language of the including center
Who cannot join
- Use of any type of anesthesia (neuraxial, epidural or local regional anesthesia) without general anesthesia
- Patients with non-regular sinus cardiac rhythm, implanted pacemakers, prescribed antimuscarinic agents, α2-adrenergic agonists, and antiarrhythmic agents others than β1-adrenergic antagonists
- Emergent surgery
- Pregnancy/lactation. Pregnancy test will be performed in all women of child bearing age
- BMI > 40 kg/m2
- Preoperative hemodynamic disturbance
Show all 19Show fewer
- Central nervous system disorder (neurologic/head trauma/uncontrolled epileptic seizures)
- Peripheric nervous system disorder (troubles of the peripheric nervous conduction, diabetic neuropathy)
- Pre-operative chronic opioid use or chronic pain, equivalent to oxycodone 20mg per oral, per day for more than 6 weeks
- Chronic use of psychoactive drugs within 90 days prior to surgery
- Medical conditions qualifying for ASA III or IV:
- Untreated or persistent peripheral or central cardiovascular disease
- Severe pulmonary disease e.g. COPD gold 4, FEV< 1.0l/s, or (evidence of) elevated paCO2 > 6.0 kPa
- Significant hepatic disease with increased bilirubin, INR or low albumin
- History of severe cardiac arrhythmia eg. Chronic atrial fibrillation.
- Active pacemaker or defibrillator
- Allergy or intolerance to any of the study drugs
- Cardiac arrhythmia during the period of the study
- Unexpected difficult airway requesting excessive, possibly painful airway manipulations
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal
Montreal East, Quebec, H1T2M4
About this study
Official title: Impact of Chronic Treatment by β1-adrenergic Antagonists on Nociceptive-Level (NOL) Index Variation After a Standardized Noxious Stimulus Under General Anesthesia: An Observational Study
The aim of the present study is to investigate the effect of chronic treatment with β1-adrenergic antagonist on the NOL index variation, the heart rate variation and the mean blood pressure variation after a standardized noxious stimulus.
Read the detailed description
Hypothesis: We hypothesize that the NOL values variations obtained in response to a standardized noxious stimulus under general anesthesia in a group of patients chronically treated with β1-adrenergic antagonists, will be similar to the NOL values variations previously obtained in response to a similar standardized noxious stimulus and previously reported in a group of patients without any β1-adrenergic antagonist.
Background: The Pain Monitoring Device (PMD200TM) monitor (Medasense Biometrics Ltd., Ramat Gan, Israel) uses the Nociception Level (NOL) index, a multiple parameter-derived index that has recently shown a good sensitivity and specificity to detect noxious stimuli. The NOL index variations of the latest version of the PMD200TM has shown better sensitivity and specificity to detect standardized noxious stimulus than heart rate or blood pressure variation in a population without any β1-adrenergic antagonist treatment. β1-adrenergic antagonist treatment was so far a limitation to the use of the NOL index. Indeed, β1-adrenergic antagonists have a depressive action on the heart rate, including limitation of the heart rate variability after a noxious stimulus. Because heart rate and its variability are parameters which are part of the parameters combined to build the NOL index, chronic treatment with β1-adrenergic antagonist could alter the ability of the NOL index to detect noxious stimulus. However, Edry R. (Edry R, 2017) assessed the impact of chronic treatment with β1-adrenergic antagonist on NOL index variation after noxious stimuli in a pilot study (9 patients under chronic treatment with β1-adrenergic antagonist and under general anesthesia) and didn't show any influence of this treatment on the NOL index variation. But this study was not large enough and did not fully answered the question whether chronic treatment with β1-adrenergic antagonist might impact NOL ability to detect precise and standardized stimulus and to compare the results to those in patients without this type of chronic medication.
Objectives:
Primary objective:
To explore the NOL variation in a group of patients under chronic treatment with β1-adrenergic antagonists submitted to standardized noxious stimulus under general anesthesia.
Secondary objectives:
Secondary outcome [1] To explore the heart rate variation and the mean blood pressure variation in a group of patients under chronic treatment with β1-adrenergic antagonists submitted to standardized noxious stimulus under general anesthesia.
Secondary outcome [2] To compare the heart rate variation and the mean blood pressure variation in a group of patients under chronic treatment with β1-adrenergic antagonists submitted to standardized noxious stimulus under general anesthesia to a control group of patients without any β1-adrenergic antagonist chronic treatment; results gathered from a previous study (Renaud-Roy E, 2019), exposed to the same noxious stimulus and under the same anesthesia conditions.
Secondary outcome [3] To explore the ability of the NOL index, the heart rate and the mean blood pressure to discriminate between noxious and non-noxious states in a group of patients with β1-adrenergic antagonist chronic treatment submitted to standardized noxious stimulus under general anesthesia. To determine sensitivity and specificity (ROC curve and AUC of ROC) for each parameter: HR, MAP, NOL index.
Secondary outcome [4] To evaluate the NOL index, the heart rate and the mean blood pressure variations after tracheal intubation in patients with β1-adrenergic antagonist chronic treatment.
Methods:
Adult patients undergoing general anesthesia for any types of surgery and who have been chronically treated with β1-adrenergic antagonists for at least three months prior to surgery will be enrolled to reach a total of patients with full analysis of data of n=25. All patients will be consented prior to the surgery. Induction of anesthesia will be standardized for all patients and based on their adjusted body weight calculated before induction, with: IV midazolam (0.02mg/kg), IV propofol (1.5-2mg.kg-1), IV remifentanil (1mcg.kg-1 followed by a continuous infusion of 0.05 µg.kg-1.min-1), IV rocuronium (0.6 to 1mg.kg-1). Depth of anesthesia with desflurane will be maintained and monitored with the BIS index kept between 40 and 60. Intubation will be performed 3 minutes after the intravenous administration of the propofol, remifentanil and rocuronium boluses. The end of the bolus of remifentanil (given 1mcg/kg; adjusted body weight) will be the start of the 3 min period to wait before proceeding with the tracheal intubation. Three minutes after intubation, the remifentanil infusion will be decreased to 0.005 µg.kg-1.min-1 to reduce the risk of developing hypotensive events and to prepare the patient for the standardized noxious stimulus of the study protocol realized under very low doses of opioids under desflurane hypnosis with BIS 40-60.
At least 10 min after the post-intubation decrease of the remifentanil infusion rate, the OR team will stop any physical contact/stimulation of the patient allowing at least a 3-minutes rest period under stable anesthesia. Baseline mean arterial blood pressure (MAP) and heart rate (HR) will be defined for the rest of the study as the mean of 3 measures in the 3 minutes during this "no pain - no touching" evaluation period to get baselines values of all the study parameters. If necessary, phenylephrine will be given to keep a MAP > 65 mmHg.
At this point, the standardized electrical (tetanic) stimulation will be applied on the area of the ulnar nerve at the wrist level, at a frequency of 100 Hz and a current of 70 mA for a duration of 30 seconds, followed by 3 minutes of observation period without any other stimulation of the patient by the anesthesia or the surgical team (EZstimII, Model ES400, Life-Tech, Stafford, Tx, USA). At the end of the observation period, the study is discontinued and the anesthesia will be conducted at the discretion of the anesthesiologist in charge of the patient.
- Conditions
- Nociception During Anesthesia in Patients Taking β1-adrenergic Antagonist Chronic Treatment
- Being tested
- standardized noxious stimulus under general anesthesia.
- Keywords
- NOL index, anesthesia, β1-adrenergic antagonist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized noxious stimulus under general anesthesia.Procedure or surgery
50 adult patients undergoing general anesthesia for any types of surgery and who have been chronically treated with β1-adrenergic antagonists for at least three months. .Induction of anesthesia will be standardized.
At least 10 min after the post-intubation decrease of the remifentanil infusion rate, the OR team will stop any physical contact/stimulation of the patient allowing at least 3-minutes.
At this point, the standardized electrical (tetanic) stimulation will be applied on the area of the ulnar nerve at the wrist level, at a frequency of 100 Hz and a current of 70 mA for a duration of 30 seconds, followed by 3 minutes of observation period without any other stimulation of the patient by the anesthesia or the surgical team. At the end of the observation period, the study is discontinued and the anesthesia will be conducted at the discretion of the anesthesiologist in charge of the patient.
| Study group | Role | What they receive |
|---|---|---|
| β1-adrenergic antagonists | Patients who have been treated for more than 3 months with β1-adrenergic antagonists Receives: Procedure: standardized noxious stimulus under general anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NOL variation (NOL is an index without unit) before and after stimulation (delta NOL), no unit, varies from 0-100
To explore the NOL variation between NOL average values before tetanic stimulation at the forearm level, and peak of NOL after stimulation (peak will be considered as an average values of 5 values around the maximal value of NOL, as the definition already used in previous studies) in a group of patients under chronic treatment with β1-adrenergic antagonists submitted to standardized noxious stimulus under general anesthesia.
Measured: Intraoperative, during anesthesia
Secondary outcomes (7)
NOL variation (NOL is an index without unit) before and after tracheal intubation (delta NOL), no unit, varies from 0-100
To explore the NOL variation between NOL average values before tracheal intubation, and peak of NOL after intubation (peak will be considered as an average values of 5 values around the maximal value of NOL, as the definition already used in previous studies) in a group of patients under chronic treatment with β1-adrenergic antagonists submitted to intubation under general anesthesia.
Measured: Intraoperative, during anesthesia
Heart Rate variation before and after tetanic stimulation (delta heart rate), in beats per minute
To explore the Heart Rate variation between heart rate average values before tetanic stimulation at the forearm level, and peak of heart rate after stimulation (peak will be considered as an average values of 5 values around the maximal value of heart rate, as the definition already used in previous studies) in a group of patients under chronic treatment with β1-adrenergic antagonists submitted to standardized noxious stimulus under general anesthesia.
Measured: Intraoperative, during anesthesia
Heart Rate variation before and after intubation (delta heart rate), in beats per minute
To explore the Heart Rate variation between heart rate average values before tracheal intubation, and peak of heart rate after tracheal intubation (peak will be considered as an average values of 5 values around the maximal value of heart rate, as the definition already used in previous studies) in a group of patients under chronic treatment with β1-adrenergic antagonists submitted to intubation under general anesthesia.
Measured: Intraoperative, during anesthesia
Mean blood pressure variation before and after stimulation (delta mean blood pressure), in mmHg
To explore the Mean Blood Pressure variation between Mean Blood Pressure average values before tetanic stimulation at the forearm level, and peak of Mean Blood Pressure after stimulation (peak will be considered as an average values of 5 values around the maximal value of Mean Blood Pressure, as the definition already used in previous studies) in a group of patients under chronic treatment with β1-adrenergic antagonists submitted to standardized noxious stimulus under general anesthesia.
Measured: Intraoperative, during anesthesia
Mean blood pressure variation before and after intubation (delta mean blood pressure), in mmHg
To explore the Mean Blood Pressure variation between Mean Blood Pressure average values before tracheal intubation, and peak of Mean Blood Pressure after tracheal intubation (peak will be considered as an average values of 5 values around the maximal value of Mean Blood Pressure, as the definition already used in previous studies) in a group of patients under chronic treatment with β1-adrenergic antagonists submitted to tracheal intubation under general anesthesia.
Measured: Intraoperative, during anesthesia
Bispectral index (BIS) variation before and after stimulation (delta BIS), no unit, varies from 0-100
To explore the BIS index variation between BIS average values before tetanic stimulation at the forearm level, and peak of BIS after stimulation (peak will be considered as an average values of 5 values around the maximal value of BIS, as the definition already used in previous studies) in a group of patients under chronic treatment with β1-adrenergic antagonists submitted to standardized noxious stimulus under general anesthesia.
Measured: Intraoperative, during anesthesia
Bispectral index (BIS) variation before and after tracheal intubation (delta BIS), no unit, varies from 0-100
To explore the BIS index variation between BIS average values before tracheal intubation, and peak of BIS after intubation (peak will be considered as an average values of 5 values around the maximal value of BIS, as the definition already used in previous studies) in a group of patients under chronic treatment with β1-adrenergic antagonists submitted to intubation under general anesthesia.
Measured: Intraoperative, during anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start27 Aug 2019
- Primary completion4 Mar 2020
- Study completion4 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nociception During Anesthesia in Patients Taking β1-adrenergic Antagonist Chronic TreatmentStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Richebe, Ciusss de L'Est de l'Île de Montréal
- Investigators
- Philippe PR Richebé, MD PhD, Principal investigator, CIUSSS Est de l'ile de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060095
- Sponsor's protocol ID
- 2020-1946
- Acronym
- BetaNOL
- Status last verified
- Aug 2020
- First submitted
- 16 Jul 2019
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chronic Treatment by β1-adrenergic Antagonists on Nociceptive-Level (NOL) Index Variation After a Standardized Noxious Stimulus Under General Anesthesia: An Observational Study
- ClinicalTrials.gov ID
- NCT04060095
- Acronym / sponsor ID
- BetaNOL / 2020-1946
- Conditions
- Nociception During Anesthesia in Patients Taking β1-adrenergic Antagonist Chronic Treatment
- Keywords
- NOL index, anesthesia, β1-adrenergic antagonist
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 16 Aug 2019 (actual)
- 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 the present study is to investigate the effect of chronic treatment with β1-adrenergic antagonist on the NOL index variation, the heart rate variation and the mean blood pressure variation after a standardized noxious stimulus.
Detailed description
Hypothesis: We hypothesize that the NOL values variations obtained in response to a standardized noxious stimulus under general anesthesia in a group of patients chronically treated with β1-adrenergic antagonists, will be similar to the NOL values variations previously obtained in response to a similar standardized noxious stimulus and previously reported in a group of patients without any β1-adrenergic antagonist.
Background: The Pain Monitoring Device (PMD200TM) monitor (Medasense Biometrics Ltd., Ramat Gan, Israel) uses the Nociception Level (NOL) index, a multiple parameter-derived index that has recently shown a good sensitivity and specificity to detect noxious stimuli. The NOL index variations of the latest version of the PMD200TM has shown better sensitivity and specificity to detect standardized noxious stimulus than heart rate or blood pressure variation in a population without any β1-adrenergic antagonist treatment. β1-adrenergic antagonist treatment was so far a limitation to the use of the NOL index. Indeed, β1-adrenergic antagonists have a depressive action on the heart rate, including limitation of the heart rate variability after a noxious stimulus. Because heart rate and its variability are parameters which are part of the parameters combined to build the NOL index, chronic treatment with β1-adrenergic antagonist could alter the ability of the NOL index to detect noxious stimulus. However, Edry R. (Edry R, 2017) assessed the impact of chronic treatment with β1-adrenergic antagonist on NOL index variation after noxious stimuli in a pilot study (9 patients under chronic treatment with β1-adrenergic antagonist and under general anesthesia) and didn't show any influence of this treatment on the NOL index variation. But this study was not large enough and did not fully answered the question whether chronic treatment with β1-adrenergic antagonist might impact NOL ability to detect precise and standardized stimulus and to compare the results to those in patients without this type of chronic medication.
Objectives:
Primary objective:
To explore the NOL variation in a group of patients under chronic treatment with β1-adrenergic antagonists submitted to standardized noxious stimulus under general anesthesia.
Secondary objectives:
Secondary outcome [1] To explore the heart rate variation and the mean blood pressure variation in a group of patients under chronic treatment with β1-adrenergic antagonists submitted to standardized noxious stimulus under general anesthesia.
Secondary outcome [2] To compare the heart rate variation and the mean blood pressure variation in a group of patients under chronic treatment with β1-adrenergic antagonists submitted to standardized noxious stimulus under general anesthesia to a control group of patients without any β1-adrenergic antagonist chronic treatment; results gathered from a previous study (Renaud-Roy E, 2019), exposed to the same noxious stimulus and under the same anesthesia conditions.
Secondary outcome [3] To explore the ability of the NOL index, the heart rate and the mean blood pressure to discriminate between noxious and non-noxious states in a group of patients with β1-adrenergic antagonist chronic treatment submitted to standardized noxious stimulus under general anesthesia. To determine sensitivity and specificity (ROC curve and AUC of ROC) for each parameter: HR, MAP, NOL index.
Secondary outcome [4] To evaluate the NOL index, the heart rate and the mean blood pressure variations after tracheal intubation in patients with β1-adrenergic antagonist chronic treatment.
Methods:
Adult patients undergoing general anesthesia for any types of surgery and who have been chronically treated with β1-adrenergic antagonists for at least three months prior to surgery will be enrolled to reach a total of patients with full analysis of data of n=25. All patients will be consented prior to the surgery. Induction of anesthesia will be standardized for all patients and based on their adjusted body weight calculated before induction, with: IV midazolam (0.02mg/kg), IV propofol (1.5-2mg.kg-1), IV remifentanil (1mcg.kg-1 followed by a continuous infusion of 0.05 µg.kg-1.min-1), IV rocuronium (0.6 to 1mg.kg-1). Depth of anesthesia with desflurane will be maintained and monitored with the BIS index kept between 40 and 60. Intubation will be performed 3 minutes after the intravenous administration of the propofol, remifentanil and rocuronium boluses. The end of the bolus of remifentanil (given 1mcg/kg; adjusted body weight) will be the start of the 3 min period to wait before proceeding with the tracheal intubation. Three minutes after intubation, the remifentanil infusion will be decreased to 0.005 µg.kg-1.min-1 to reduce the risk of developing hypotensive events and to prepare the patient for the standardized noxious stimulus of the study protocol realized under very low doses of opioids under desflurane hypnosis with BIS 40-60.
At least 10 min after the post-intubation decrease of the remifentanil infusion rate, the OR team will stop any physical contact/stimulation of the patient allowing at least a 3-minutes rest period under stable anesthesia. Baseline mean arterial blood pressure (MAP) and heart rate (HR) will be defined for the rest of the study as the mean of 3 measures in the 3 minutes during this "no pain - no touching" evaluation period to get baselines values of all the study parameters. If necessary, phenylephrine will be given to keep a MAP > 65 mmHg.
At this point, the standardized electrical (tetanic) stimulation will be applied on the area of the ulnar nerve at the wrist level, at a frequency of 100 Hz and a current of 70 mA for a duration of 30 seconds, followed by 3 minutes of observation period without any other stimulation of the patient by the anesthesia or the surgical team (EZstimII, Model ES400, Life-Tech, Stafford, Tx, USA). At the end of the observation period, the study is discontinued and the anesthesia will be conducted at the discretion of the anesthesiologist in charge of the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| β1-adrenergic antagonists | – | Procedure: standardized noxious stimulus under general anesthesia.Patients who have been treated for more than 3 months with β1-adrenergic antagonists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Enrollment of a total of 25 adult patients undergoing general anesthesia for elective surgery (full data analysis available for 25 patients; inclusion until this n is reached). This number was determined on two previous studies conducted at Maisonneuve-Rosemont on the NOL index reactivity to the same stimulus and under the same anesthesia conditions and published in 2018 (Stockle PA et al. Minerva Anestesiologica) and 2019 (Renaud-Roy et al. CJA) from which we got full data from 25 patients who were not chronically treated by β1-adrenergic antagonists. We will compare this previous cohort to the new prospective cohort of patients chronically treated with β1-adrenergic antagonists.
Key inclusion criteria (5 listed)
- Patient age > 18 years
- ASA I-III
- Adult patients scheduled to undergo elective surgery under general anesthesia
- Patients chronically treated with β1-adrenergic antagonists for at least three months prior to surgery
- Patient able to consent in the language of the including center
Key exclusion criteria (19 listed)
- Use of any type of anesthesia (neuraxial, epidural or local regional anesthesia) without general anesthesia
- Patients with non-regular sinus cardiac rhythm, implanted pacemakers, prescribed antimuscarinic agents, α2-adrenergic agonists, and antiarrhythmic agents others than β1-adrenergic antagonists
- Emergent surgery
- Pregnancy/lactation. Pregnancy test will be performed in all women of child bearing age
- BMI > 40 kg/m2
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 |
|---|---|---|
| standardized noxious stimulus under general anesthesia.50 adult patients undergoing general anesthesia for any types of surgery and who have been chronically treated with β1-adrenergic antagonists for at least three months. .Induction of anesthesia will be standardized. At least 10 min after the post-intubation decrease of the remifentanil infusion rate, the OR team will stop any physical contact/stimulation of the patient allowing at least 3-minutes. At this point, the standardized electrical (tetanic) stimulation will be applied on the area of the ulnar nerve at the wrist level, at a frequency of 100 Hz and a current of 70 mA for a duration of 30 seconds, followed by 3 minutes of observation period without any other stimulation of the patient by the anesthesia or the surgical team. At the end of the observation period, the study is discontinued and the anesthesia will be conducted at the discretion of the anesthesiologist in charge of the patient. | Procedure or surgery | β1-adrenergic antagonists |
Primary outcome
NOL variation (NOL is an index without unit) before and after stimulation (delta NOL), no unit, varies from 0-100
Time frame: Intraoperative, during anesthesia
To explore the NOL variation between NOL average values before tetanic stimulation at the forearm level, and peak of NOL after stimulation (peak will be considered as an average values of 5 values around the maximal value of NOL, as the definition already used in previous studies) in a group of patients under chronic treatment with β1-adrenergic antagonists submitted to standardized noxious stimulus under general anesthesia.
7 secondary outcomes
NOL variation (NOL is an index without unit) before and after tracheal intubation (delta NOL), no unit, varies from 0-100
Time frame: Intraoperative, during anesthesia
Heart Rate variation before and after tetanic stimulation (delta heart rate), in beats per minute
Time frame: Intraoperative, during anesthesia
Heart Rate variation before and after intubation (delta heart rate), in beats per minute
Time frame: Intraoperative, during anesthesia
Mean blood pressure variation before and after stimulation (delta mean blood pressure), in mmHg
Time frame: Intraoperative, during anesthesia
Mean blood pressure variation before and after intubation (delta mean blood pressure), in mmHg
Time frame: Intraoperative, during anesthesia
Bispectral index (BIS) variation before and after stimulation (delta BIS), no unit, varies from 0-100
Time frame: Intraoperative, during anesthesia
Bispectral index (BIS) variation before and after tracheal intubation (delta BIS), no unit, varies from 0-100
Time frame: Intraoperative, during anesthesia
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 2 Sep 2020.
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 PR Richebé, MD PhD principal investigator
CIUSSS Est de l'ile de Montreal
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 Nociception During Anesthesia in Patients Taking β1-adrenergic Antagonist Chronic Treatment, run by Ciusss de L'Est de l'Île de Montréal 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 5 inclusion and 19 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 2 Sep 2020. 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?
NOL variation (NOL is an index without unit) before and after stimulation (delta NOL), no unit, varies from 0-100 (time frame: Intraoperative, during anesthesia). 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 2 Sep 2020.