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

NCT06981494 | Recruiting

• 1 other identifier: Soh-Med--25-4-02MS
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Assessment of hemodynmaic stability

  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.

  6 months

Study Arms (2)

Dexmedetomidine Group (D)

ACTIVE COMPARATOR

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.

Drug: Dexmedetomidine

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

ACTIVE COMPARATOR

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.

Drug: Dexmedetomidine and ketamine ( Ketodex )

Interventions

Dexmedetomidine DRUG

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.

Dexmedetomidine Group (D)

Dexmedetomidine and ketamine ( Ketodex ) DRUG

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.

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of medicine

Sohag, Egypt

RECRUITING

MeSH Terms

Conditions

Microphthalmia, syndromic 7

Interventions

Dexmedetomidine; Ketamine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia resident

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: May 20, 2025
• Study Start: February 5, 2025
• Primary Completion: August 10, 2025
• Study Completion: December 10, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

EG (1)