Status:
RECRUITING
Dexmedetomidine Versus Dexmedetomidine and Ketamine (Ketodex) in Ear and Nose Surgeries
Lead Sponsor:
Sohag University
Conditions:
Ear and Nose Surgeries With Hypotensive Anaesthesia e.g FESS , MLS , TURBINECTOMY
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The study aims to compare the efficacy, safety and overall effectiveness of dexmedetomidine and dexmedtomidine and ketamine (ketodex) in achieving controlled hypotension during Ear and nose surgeries....
Detailed Description
Comparison regarding the efficacy, safety and overall effectiveness of dexmedetomidine and dexmedtomidine and ketamine (ketodex) in achieving controlled hypotension during Ear and nose surgeries. * c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2025
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06981494
Start Date
February 5 2025
End Date
December 10 2025
Last Update
May 20 2025
Active Locations (1)
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1
Faculty of medicine
Sohag, Egypt