Status:
COMPLETED
Impact of Chronic Treatment by β1-adrenergic Antagonists on Nociceptive-Level (NOL) Index Variation After a Standardized Noxious Stimulus Under General Anesthesia
Lead Sponsor:
Ciusss de L'Est de l'Île de Montréal
Conditions:
Nociception During Anesthesia in Patients Taking β1-adrenergic Antagonist Chronic Treatment
Eligibility:
All Genders
18+ years
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
August 27 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 4 2020
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04060095
Start Date
August 27 2019
End Date
March 4 2020
Last Update
September 2 2020
Active Locations (1)
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1
Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal
Montreal East, Quebec, Canada, H1T2M4