Comparing dexmedetomidine alone versus with ketamine for ear and nose surgeries
Dexmedetomidine Versus Dexmedetomidine and Ketamine (Ketodex) Regarding Hemodynamics Stability, Recovery and Postoperative Pain in Ear and Nose Surgeries, A Prospective Randomized Study
This study is testing whether using dexmedetomidine alone or with ketamine can help patients aged 18-60 have safer and more comfortable ear and nose surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag) |
| Trial ID | NCT06981494 on ClinicalTrials.gov |
What this trial studies
This study compares the efficacy and safety of dexmedetomidine alone versus a combination of dexmedetomidine and ketamine (ketodex) in achieving controlled hypotension during ear and nose surgeries. It assesses the analgesic and sedative effects of both drug regimens and evaluates their impact on recovery and hemodynamic stability. The trial focuses on patients aged 18-60 years who are scheduled for elective surgeries requiring controlled hypotensive anesthesia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with stable cardiovascular health undergoing elective ear and nose surgeries requiring controlled hypotensive anesthesia.
Not a fit: Patients with severe cardiovascular or respiratory conditions, or those with significant drug allergies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve anesthesia management during ear and nose surgeries, leading to better patient outcomes and recovery.
How similar studies have performed: While there have been studies on dexmedetomidine and ketamine individually, this specific comparison in the context of controlled hypotension during ear and nose surgeries is relatively novel.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Sohag
- Faculty of medicine — Sohag, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.