This randomized controlled study aims to evaluate the effects of preoperative dexmedetomidine and tramadol on perioperative anxiety, postoperative pain, sedation, and hemodynamic parameters in patients undergoing hemorrhoidectomy under saddle spinal anesthesia with low-dose hyperbaric bupivacaine. 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) at predefined postoperative time points. Intraoperative hemodynamic parameters, sedation levels, and rescue sedative requirements will also be recorded and compared among the study groups.
This prospective, randomized, double-blind, controlled study is designed to investigate the effects of preoperative dexmedetomidine and tramadol on perioperative anxiety, postoperative pain, sedation, and intraoperative hemodynamic parameters in patients undergoing elective hemorrhoidectomy under saddle 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 receive 10 mL of 0.9% saline intravenously over 10 minutes before spinal anesthesia as placebo. All patients will undergo saddle spinal anesthesia using 1.5 mL (7.5 mg) of 0.5% hyperbaric bupivacaine administered intrathecally via the L4-L5 interspace. 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 postoperative time points. Intraoperative hemodynamic parameters, including heart rate and blood pressure, will be recorded throughout the procedure. Sedation levels and rescue midazolam requirements will also be recorded. The primary outcome of the study is the change in STAI-State (STAI-S) scores over time among study groups. Secondary outcomes include postoperative pain scores, intraoperative hemodynamic changes, sedation levels, and rescue sedative requirements among the groups. Immediate postoperative pain measurements will be recorded; however, because residual spinal anesthesia effects are expected during the early postoperative period, primary postoperative pain analyses will primarily focus on later postoperative time points.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
Dexmedetomidine administered intravenously as a 1 mcg/kg loading dose over 10 minutes before spinal anesthesia.
Tramadol administered intravenously as a 1 mg/kg loading dose over 10 minutes before spinal anesthesia.
10 mL of 0.9% saline administered intravenously over 10 minutes before spinal anesthesia.
Van Yuzuncu Yil University School of Medicine Department of Anesthesiology and Reanimation
Van, Tuşba, Turkey (Türkiye)
Change in Perioperative STAI-State (STAI-S) Scores
Evaluation of changes in STAI-State (STAI-S) scores over time among study groups with respect to group effect, time effect, and group × time interaction.
Time frame: Baseline (one day before surgery), immediately before spinal anesthesia on the day of surgery, and postoperative 24 hours
Postoperative Pain Score (VAS)
Postoperative pain assessed using the Visual Analog Scale (VAS) at 0, 4, and 12 hours after surgery.
Time frame: 0, 4, and 12 hours after surgery
Intraoperative Hemodynamic Parameters
Systolic and diastolic blood pressure, heart rate, and oxygen saturation measured at 5-minute intervals during surgery.
Time frame: During surgery, measured at 5-minute intervals
Sedation Level (Ramsay Sedation Scale)
Sedation level assessed using the Ramsay Sedation Scale at 0, 4, 12, and 24 hours after surgery among study groups.
Time frame: 0, 4, 12, and 24 hours after surgery
Additional Sedative Requirement
Total dose of midazolam administered intraoperatively for sedation.
Time frame: From initiation of spinal anesthesia until the end of surgery
Postoperative Anxiety Level (STAI-S Score)
State-Trait Anxiety Inventory-State (STAI-S) score assessed postoperatively when Ramsay Sedation Score is ≤3 among study groups.
Time frame: 24 hours after surgery
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