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 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT06981494
Eligibility Criteria:
Inclusion Criteria
* Age Range: Patients aged 18-60 years who are scheduled for elective Ear and nose surgeries requiring controlled hypotensive anesthesia.
* ASA Classification: Patients classified as American Society of Anesthesiologists (ASA) physical status I or II.
* Surgical Procedures: Individuals undergoing specific ear and nose surgeries where controlled hypotensive anesthesia is typically indicated.
* Stable Cardiovascular Health: Patients with stable cardiovascular function, without significant history of uncontrolled hypertension , hypotension or ischaemic heart diseases.
Exclusion Criteria
* Severe Cardiovascular Conditions: Patients with severe cardiovascular diseases such as congestive heart failure, uncontrolled hypertension , arrhythmias or ischaemic heart diseases .
* Any cardiac patients.
* Respiratory Conditions: Individuals with significant respiratory conditions like chronic obstructive pulmonary disease (COPD) or severe asthma.
* Drug Allergies: Patients with known hypersensitivity or allergic reactions to dexmedetomidine, ketamine or any other components of the study drugs.
* Pregnancy or Lactation: Pregnant or breastfeeding women, due to potential risks to the fetus or infant.
* Chronic Medication Use: Patients on chronic medications that could interfere with blood pressure regulation or interact with the study drugs (e.g., beta-blockers, MAO inhibitors).
* Patients with chronic liver or renal diseases.
* Psychiatric or Neurological Disorders: Individuals with severe psychiatric or neurological disorders that could impact the study outcomes or the patient's ability to consent.
* Substance Abuse: Patients with a history of substance abuse, particularly involving sedatives or opioids, which could affect anesthesia requirements or recovery.
* Coagulation Disorders: Individuals with coagulation disorders or on anticoagulant therapy, due to the increased risk of bleeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06981494
Study Brief:
Protocol Section:
NCT06981494