Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:21 PM
Ignite Modification Date:
2025-12-24 @ 2:21 PM
NCT ID:
NCT04060095
Eligibility Criteria:
Inclusion Criteria:
1. Patient age \> 18 years
2. ASA I-III
3. Adult patients scheduled to undergo elective surgery under general anesthesia
4. Patients chronically treated with β1-adrenergic antagonists for at least three months prior to surgery
5. Patient able to consent in the language of the including center
Exclusion Criteria:
1. Use of any type of anesthesia (neuraxial, epidural or local regional anesthesia) without general anesthesia
2. Patients with non-regular sinus cardiac rhythm, implanted pacemakers, prescribed antimuscarinic agents, α2-adrenergic agonists, and antiarrhythmic agents others than β1-adrenergic antagonists
3. Emergent surgery
4. Pregnancy/lactation. Pregnancy test will be performed in all women of child bearing age
5. BMI \> 40 kg/m2
6. Preoperative hemodynamic disturbance
7. Central nervous system disorder (neurologic/head trauma/uncontrolled epileptic seizures)
8. Peripheric nervous system disorder (troubles of the peripheric nervous conduction, diabetic neuropathy)
9. Pre-operative chronic opioid use or chronic pain, equivalent to oxycodone 20mg per oral, per day for more than 6 weeks
10. Chronic use of psychoactive drugs within 90 days prior to surgery
11. Medical conditions qualifying for ASA III or IV:
1. Untreated or persistent peripheral or central cardiovascular disease
2. Severe pulmonary disease e.g. COPD gold 4, FEV\< 1.0l/s, or (evidence of) elevated paCO2 \> 6.0 kPa
3. Significant hepatic disease with increased bilirubin, INR or low albumin
4. History of severe cardiac arrhythmia eg. Chronic atrial fibrillation.
5. Active pacemaker or defibrillator
12. Allergy or intolerance to any of the study drugs
13. Cardiac arrhythmia during the period of the study
14. Unexpected difficult airway requesting excessive, possibly painful airway manipulations
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04060095
Study Brief:
Protocol Section:
NCT04060095