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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT06385002
Eligibility Criteria:
Inclusion Criteria:
* Adult patients aged 19 to 70 undergoing gynecologic and laparoscopic surgery under general anesthesia
* Patients classified as American Society of Anesthesiologists (ASA) physical status classification I or II
* According to the American Society of Anesthesiologists (ASA) physical status classification:
Class I - Healthy patients without systemic disease Class II - Patients with mild systemic disease without functional limitation Class III - Patients with severe systemic disease that limits activity but is not incapacitating Class IV - Patients with incapacitating systemic disease that is a constant threat to life Class V - Moribund patients who are not expected to survive without the operation Class VI - Brain-dead patients for organ donation
Exclusion Criteria:
* Patients classified as ASA physical status classification III or above
* Pregnant women
* Patients with hypersensitivity to sevoflurane or other halogenated anesthetics, malignant hyperthermia, or a history of it in the patient or family
* Patients with preoperative impairment of consciousness or coma
* Patients undergoing emergency surgery or those who are hemodynamically unstable preoperatively
* Patients with a history of neuromuscular disorders or medication affecting neuromuscular function
* Patients who have taken sedatives (anxiolytics, hypnotics, antipsychotics, antidepressants, or sleeping pills) within 24 hours
* Patients receiving long-term benzodiazepine therapy
* Patients with alcohol or substance dependence
* Patients with allergy history to benzodiazepines or flumazenil
* Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
* Patients with severe hypersensitivity reactions to dextran 40
* Patients with chronic renal failure requiring hemodialysis
* Patients with a history of acute angle-closure glaucoma
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
19 Years
Maximum Age:
70 Years
Study:
NCT06385002
Study Brief:
Protocol Section:
NCT06385002