Dexmedetomidine Versus Dexmedetomidine and Ketamine (Ketodex) in Ear and Nose Surgeries

Sohag University

Status: Enrolling

Conditions: Ear and Nose Surgeries With Hypotensive Anaesthesia e.g FESS , MLS , TURBINECTOMY

Treatments: Drug: Dexmedetomidine; Drug: Dexmedetomidine and ketamine ( Ketodex )

Study type: Interventional

Funder types: Other

Identifiers

NCT06981494

Soh-Med--25-4-02MS

Details and patient eligibility

About

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.

Full 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

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Dexmedetomidine Group (D)

Active Comparator group

Description:

Dexmedetomidine Group (D) : We give intravenous the loading and maintenance dose of the general anaesthesia drug Dexmedetomidine Loading Dose: Dexmedetomidine is usually administered as a loading dose of 0.5 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.

Treatment:

Drug: Dexmedetomidine

Ketodex Group (Combination of Ketamine and Dexmedetomidine) (K):

Active Comparator group

Description:

Ketamine Component: We give intravenous the loading and maintenance dose of the general anaesthesia drug Dexmedetomidine and ketamine 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 0.5 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.

Treatment:

Drug: Dexmedetomidine and ketamine ( Ketodex )