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:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT05841667
Eligibility Criteria:
Inclusion Criteria:
* American Society of Anesthesiologists (ASA) physical status 1 or 2
* Age 19-70 years
* Elective surgery
Exclusion Criteria:
* Concomitant regional anesthesia
* Uncontrolled hypertension (systolic blood pressure \>180 mmHg)
* Uncontrolled diabetes mellitus (HbA1c \>9.0%)
* Aspartate transaminase (AST), Alanine transferase (ALT), Total bilirubin \> more than 2 times the normal upper limit
* Estimated glomerular filtration rate \<60 ml/min/1.73m2
* Moderate to severe chronic pulmonary obstructive disease or respiratory failure
* Emergency
* Hepatectomy, Liver transplantation
* Cardiopulmonary bypass use
* Craniotomy due to head trauma, unstable intracranial pressure, or brain disease
* Use of benzodiazepine medications (if tolerance is present)
* Anxiety, alcohol/drug dependence, or addiction to tricyclic antidepressants
* Reported hypersensitivity and adverse reactions to benzodiazepines, flumazenil, and other agents used during anesthesia
* Lactose-related genetic disorders
* Myasthenia gravis or myasthenia gravis syndrome
* Newly diagnosed myocardial infarction/clinically significant coronary artery disease, cerebral ischemic attack/stroke within 6 months, or significant untreated coronary artery disease
* Implanted rate-responsive cardiac pacemaker with a bioelectrical impedance sensor.
* Intrinsic brain disorders or other conditions that make it difficult to determine the depth of anesthesia through EEG measurements (e.g., epilepsy)
* History of severe allergies
* Cognitive impairment that prevents comprehension of the instructions and consent form of this study, in case of sedation
* Expected intraoperative blood loss of 1000 ml or more
* Judged by the investigator to be unsuitable for participation in this study due to other reasons
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
70 Years
Study:
NCT05841667
Study Brief:
Protocol Section:
NCT05841667