Ear and Nose Surgeries With Hypotensive Anaesthesia e.g FESS , MLS , TURBINECTOMY
Conditions
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. \- Assessment the analgesic and sedative role of both drugs.
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. * comparison between both drugs in recovery and hemodynamics stability * Assessment the analgesic and sedative role of both drugs
Interventions
DRUGDexmedetomidine
Loading Dose: Dexmedetomidine is usually administered as a loading dose of 0.25 mcg/kg slowly. Maintenance Dose: After the loading dose, the maintenance infusion rate is typically 0.2 to 0.7 mcg/kg/hour in syringe pump . The exact rate can be adjusted based on the hemodynamics of the patient (blood pressure and heart rate) and the patient's response.
DRUGDexmedetomidine and ketamine ( Ketodex )
Ketodex Group (Combination of Ketamine and Dexmedetomidine) (K): Ketamine Component: Loading Dose: Ketamine is typically given at a dose of 0.5 mg/kg as a bolus injection. Maintenance Dose: A maintenance infusion of 0.2 to 0.5 mg/kg/hour is common to maintain anesthesia in syringe pump. Dexmedetomidine Component: Loading Dose: As with the dexmedetomidine group, a loading dose of 0.25 mcg/kg slowly is administered. Maintenance Dose: The maintenance infusion rate for dexmedetomidine remains 0.2 to 0.7 µg/kg/hour in syringe pump.
Sponsors
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of hemodynmaic stability | 6 months | Assess Hemodynamic Stability: Compare the hemodynamic stability provided by dexmedetomidine and ketodex, focusing on parameters such as blood pressure and heart rate will be monitored every 5 minutes and we will record the average every 20 minutes intraoperative . This monitoring will help assess the stability of each patient and the safety profile of the anesthetic agents used in the study. |
Countries
Egypt
Outcome results
None listed