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 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT01975727
Eligibility Criteria:
Inclusion Criteria:
* Adults (age ≥18 years), male or female.
* American Society of Anesthesiology (ASA) status I to III.
* Able to read and understand the information sheet
* Subjects who have signed and dated the consent form.
* Scheduled for elective surgery.
* If the patient is female and of childbearing potential, she must have a negative pregnancy test (serum hCG or urine dipstick).
Exclusion criteria:
* A history of allergy or hypersensitivity to dexamethasone or any component of its formulation.
* Hepatic dysfunction\* (i.e bilirubin \<1.5 upper limit normal (ULN), alanine aminotransferase (ALT) \<2.5 x ULN, aspartate aminotransferase (AST) \<2.5 x ULN).
* Renal insufficiency\* (i.e. creatinine \<1.5 x ULN, creatinine clearance \<30ml min-1).
* Pregnant, or intending to become pregnant, women.
* Breastfeeding women.
* Patient having used any investigational drug within 30 days of screening.
* Patient having participated in any clinical trial within 30 days.
* Patients with active GI ulcer.
* Patients needing prolonged postoperative intubation.
* Patients needing a gastric tube postoperatively.
* Patients receiving antiemetic drugs (butyrophenones, 5-HT3 receptor antagonists, dexamethasone).
* Patients taking drugs that interfere with platelet aggregation (for instance, aspirine or clopidogrel) within seven days preoperatively.
* Patients with overt psychosis or taking antipsychotic treatment (for instance, anti-dopaminergic drugs).
* Patients taking drugs with known emetogenic potency (for instance, L-Dopa, COMT inhibitors).
* Specific types of surgery: tonsillectomy (increased risk of postoperative bleeding), interventions that require strict prevention of postoperative vomiting.
* Systemic infections (bacterial, fungal, malaria, viral, tuberculosis).
* Local infections (for instance, ocular herpes simplex).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01975727
Study Brief:
Protocol Section:
NCT01975727