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Search / Trial NCT06981494

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

Launched by SOHAG UNIVERSITY · May 13, 2025

Trial Information

Current as of July 27, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two different approaches to anesthesia during ear and nose surgeries, like surgery for sinus issues or nasal obstructions. The researchers want to see if using dexmedetomidine alone is as effective and safe as combining it with ketamine, which is called Ketodex. The goal is to provide controlled low blood pressure during these procedures, which can help with safety and comfort.

To participate, you need to be between 18 and 60 years old and scheduled for specific elective ear or nose surgeries that require this type of anesthesia. You should also be in good overall health, particularly with stable heart function. The trial is currently looking for volunteers, and if you join, you can expect careful monitoring throughout the procedure to ensure your comfort and safety. Keep in mind, there are certain medical conditions and medications that may prevent you from participating, so it's important to discuss your health history with the study team.

Gender

ALL

Eligibility 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.

About Sohag University

Sohag University is a distinguished academic institution located in Sohag, Egypt, committed to advancing healthcare through rigorous clinical research. As a clinical trial sponsor, the university leverages its robust infrastructure and multidisciplinary expertise to facilitate innovative studies aimed at improving patient outcomes and contributing to the global body of medical knowledge. With a focus on ethical standards and scientific integrity, Sohag University collaborates with healthcare professionals and researchers to conduct trials that address critical health issues, ensuring the advancement of evidence-based practices in the healthcare community.

Locations

Sohag, , Egypt

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported