Dexmedetomidine vs Tramadol to reduce anxiety, pain, and stabilize hemodynamics during hemorrhoidectomy
A Randomized Double-Blind Study Comparing the Effects of Preoperative Dexmedetomidine Versus Tramadol on Anxiety, Pain, and Hemodynamics in Patients Undergoing Hemorrhoidectomy
NA · Yuzuncu Yil University · NCT06860100
This study tests whether a single IV dose of dexmedetomidine or tramadol given before spinal anesthesia can lower anxiety, reduce postoperative pain, and keep heart rate and blood pressure stable in adults having hemorrhoidectomy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | Yuzuncu Yil University (other) |
| Locations | 1 site (Van, Tuşba) |
| Trial ID | NCT06860100 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, controlled trial that randomly assigns adults undergoing elective hemorrhoidectomy under spinal anesthesia to receive preoperative dexmedetomidine, tramadol, or no premedication. Dexmedetomidine is given as a 1 µg/kg IV loading infusion over 10 minutes and tramadol as 1 mg/kg IV over 10 minutes prior to spinal anesthesia. Preoperative anxiety is measured with the State-Trait Anxiety Inventory (STAI), postoperative pain with the Visual Analog Scale (VAS) at predefined intervals, and intraoperative hemodynamics (heart rate and blood pressure) are recorded throughout the procedure. The primary outcome is change in STAI from baseline; secondary outcomes include VAS pain scores and intraoperative hemodynamic changes.
Who should consider this trial
Good fit: Adults aged 20–60 years with ASA physical status I–II scheduled for elective hemorrhoidectomy under spinal anesthesia who can provide informed consent are ideal candidates.
Not a fit: Patients outside the 20–60 age range, with ASA III or higher, severe hepatic or renal disease, contraindications to spinal anesthesia, or known allergy to dexmedetomidine or tramadol are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the intervention could reduce perioperative anxiety and postoperative pain while improving hemodynamic stability for patients having hemorrhoidectomy.
How similar studies have performed: Previous perioperative studies in other surgical settings have shown that dexmedetomidine and tramadol can reduce anxiety and postoperative pain, but direct comparisons specifically in hemorrhoidectomy are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients aged between 20 and 60 years ASA physical status I-II Scheduled for hemorrhoidectomy under spinal anesthesia Provided written informed consent Exclusion Criteria: ASA physical status III or higher Age below 20 or above 60 years Patients who refused or were unable to provide informed consent Known allergy to dexmedetomidine or tramadol Severe hepatic or renal disease Coagulopathy or contraindication to spinal anesthesia
Where this trial is running
Van, Tuşba
- Van Yuzuncu Yil University School of Medicine Department of Anesthesiology and Reanimation — Van, Tuşba, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Arzu Esen Tekeli, MD
- Email: esentekeli190807@hotmail.com
- Phone: +905053756375
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.
Conditions: Hemorrhoids, Perioperative Anxiety, Postoperative Pain, analgesia, sedation, perioperative anxiety, intraoperative hemodynamics