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:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
NCT ID:
NCT07269106
Eligibility Criteria:
Inclusion Criteria:
* Scheduled for ophthalmic surgery under general anesthesia.
* Aged 18 to 70 years.
* With American Society of Anesthesiologists (ASA) physical status I to III.
* Body mass index (BMI) between 18 and 30 kg/m²
* Agree to participate in the trial and provide written informed consent.
Exclusion Criteria:
* History of cardiovascular or cerebrovascular events within the past 6 months, including unstable angina, ischemic myocardial infarction, or heart failure; or current presence of uncontrolled hypertension (\>180/110 mmHg), aneurysm, or severe cardiac arrhythmia.
* Severe respiratory diseases such as pulmonary fibrosis, severe pulmonary abscess, cor pulmonale, or advanced chronic obstructive pulmonary disease (COPD).
* Significant neurological disorders such as brain injury or seizures, as well as severe psychiatric illnesses.
* Known allergy to kappa opioid receptor agonists or to general anesthetic agents used in this study.
* Current peptic ulcer disease, gastrointestinal bleeding, or known hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs), such as flurbiprofen axetil or paracetamol.
* Prior use of opioid or non-opioid analgesics, with the last administration occurring within five half-life periods of the drug.
* Continuous use of opioid analgesics for more than 10 days within the 3 months prior to screening.
* Use of drugs with unknown half-life periods that may affect analgesic efficacy within 14 days before randomization.
* History of major surgery within the past 3 months that may interfere with postoperative pain assessment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07269106
Study Brief:
Protocol Section:
NCT07269106