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 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT04049656
Eligibility Criteria:
Inclusion Criteria:
* Able to provide informed consent
* American Society of Anesthesiologist Physical Status 1 or 2
* Body Mass Index range of 19-35 kg.m-2.
* Planned spinal or open abdominal surgery expected to last 1-3 hours utilizing a balanced sevoflurane-fentanyl general anesthetic
Exclusion Criteria:
* Subjects are unable or unwilling to give informed consent.
* Emergency surgery
* Women who are currently pregnant or not using a medically acceptable means of birth control
* Cardiac morbidity, including non-regular sinus cardiac rhythm or implanted cardiac pacemaker
* Concurrent medications with a major effect upon the sinus node including prescribed antimuscarinic agents, α2-adrenergic agonists, β1-adrenergic antagonists, and antiarrhythmic agents
* Expected duration of surgery less than 1 hour (60 minutes) or greater than 3 hours (180 minutes)
* Pre-operative chronic opioid use or chronic pain, equivalent to requiring oxycodone 20mg per oral, per day for more than 6 weeks
* Allergy or intolerance to any of the anticipated study medications, such as history of malignant hyperthermia during anesthesia
* Planned use of neuraxial anesthesia
* Clinically significant abnormality or clinically significant unstable medical condition, as indicated by medical history, physical examination, ECG results, or clinical laboratory testing, that in the Investigator's judgment might pose a potential safety risk to the subject or limit interpretation of the trial results, e.g., any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunctioning.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04049656
Study Brief:
Protocol Section:
NCT04049656