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Recruiting Not applicable NCT06860100

Dexmedetomidine vs Tramadol for Anxiety, Pain, and Hemodynamics in Hemorrhoidectomy

No applicable phase (e.g. observational)
Conditions: Hemorrhoids Perioperative Anxiety Postoperative Pain

Sponsor: Yuzuncu Yil University

trial.available_in: БГ
Overview
This randomized controlled study aims to evaluate the effects of preoperative dexmedetomidine and tramadol on anxiety, pain, and hemodynamic parameters in patients undergoing hemorrhoidectomy under spinal anesthesia. Preoperative anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI), and postoperative pain will be evaluated using the Visual Analog Scale (VAS). Intraoperative hemodynamic parameters will also be recorded and compared among the study groups.
Description
This prospective, randomized, controlled study is designed to investigate the effects of preoperative dexmedetomidine and tramadol on perioperative anxiety, postoperative pain, and intraoperative hemodynamic parameters in patients undergoing hemorrhoidectomy under spinal anesthesia. Eligible patients aged 20-60 years with ASA physical status I-II scheduled for elective hemorrhoidectomy will be enrolled. After obtaining written informed consent, patients will be randomly allocated into three groups: dexmedetomidine group, tramadol group, and control group. Patients in the dexmedetomidine group will receive 1 µg/kg dexmedetomidine administered intravenously as a loading infusion over 10 minutes prior to spinal anesthesia. Patients in the tramadol group will receive 1 mg/kg tramadol administered intravenously as a loading infusion over 10 minutes prior to spinal anesthesia. The control group will not receive any preoperative sedative or analgesic medication. Preoperative anxiety will be assessed using the State-Trait Anxiety Inventory (STAI). Postoperative pain will be evaluated using the Visual Analog Scale (VAS) at predefined time intervals. Intraoperative hemodynamic parameters, including heart rate and blood pressure, will be recorded throughout the procedure. The primary outcome of the study is the change in STAI scores from preoperative baseline to the postoperative period. Secondary outcomes include postoperative pain scores and intraoperative hemodynamic changes among the groups.
Who can participate
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
Interventions
Dexmedetomidine
DRUG
Tramadol
DRUG
Locations 1
Turkey (1)
Van Yuzuncu Yil University School of Medicine Department of Anesthesiology and Reanimation
Van , Tuşba
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
20 Years
Maximum age
60 Years
Healthy volunteers
No
Start date
17.11.2025
Completion date
01.09.2026
Registry ID
NCT06860100
Source
clinicaltrials.gov
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