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NCT Number: NCT06981494

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

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.

Recruiting

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Key information

Conditions

Ear and Nose Surgeries With Hypotensive Anaesthesia e.g FESS , MLS , TURBINECTOMY Microphthalmia, syndromic 7

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. Assessment of hemodynmaic stability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Dexmedetomidine Versus Dexmedetomidine and Ketamine (Ketodex) Regarding Hemodynamics Stability, Recovery and Postoperative Pain in Ear and Nose Surgeries, A Prospective Randomized Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 20, 2025
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.