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

Overview

This prospective, randomized, double-blind, placebo-controlled trial evaluates whether preoperative intravenous dexmedetomidine or tramadol reduces perioperative anxiety compared with placebo in patients undergoing elective hemorrhoidectomy under saddle spinal anesthesia. Perioperative anxiety is assessed using the State-Trait Anxiety Inventory-State (STAI-S), while postoperative pain is evaluated using the Visual Analog Scale (VAS). Intraoperative hemodynamic parameters, supplemental midazolam requirements, and safety outcomes are also recorded to compare the effects of the three treatment strategies.

This prospective, randomized, double-blind, placebo-controlled study is designed to evaluate the effects of preoperative intravenous dexmedetomidine and tramadol on perioperative anxiety, postoperative pain, and intraoperative hemodynamic responses in patients undergoing elective hemorrhoidectomy under saddle spinal anesthesia. Eligible patients aged 20-60 years with American Society of Anesthesiologists (ASA) physical status I-II scheduled for elective hemorrhoidectomy will be enrolled after providing written informed consent. Participants will be randomly allocated to one of three parallel groups: dexmedetomidine, tramadol, or placebo (normal saline). Patients assigned to the dexmedetomidine group will receive dexmedetomidine 1 μg/kg administered intravenously as a loading infusion over 10 minutes before spinal anesthesia. Patients assigned to the tramadol group will receive tramadol 1 mg/kg administered intravenously over 10 minutes before spinal anesthesia. Patients in the placebo group will receive 10 mL of 0.9% normal saline intravenously over the same period. All patients will undergo saddle spinal anesthesia using 1.5 mL (7.5 mg) of 0.5% hyperbaric bupivacaine administered intrathecally through the L4-L5 interspace according to a standardized anesthetic protocol. Perioperative anxiety will be evaluated using the State-Trait Anxiety Inventory-State (STAI-S) questionnaire at baseline, after study drug infusion before spinal anesthesia, immediately after surgery, and 12 and 24 hours postoperatively. Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS) preoperatively and at 0, 12, and 24 hours after surgery. Intraoperative heart rate, systolic, diastolic, and mean arterial blood pressures, peripheral oxygen saturation, rescue midazolam requirements, and adverse events will be recorded throughout the perioperative period.To standardize postoperative analgesia across all study groups, intravenous paracetamol (15 mg/kg) was routinely administered to all participants at the postoperative sixth hour according to the institutional analgesia protocol. The primary outcome is the change in STAI-State (STAI-S) scores over time among the three study groups. Secondary outcomes include postoperative pain intensity, intraoperative hemodynamic parameters, rescue midazolam requirements, and the incidence of treatment-related adverse events. Because residual spinal anesthesia is expected to influence immediate postoperative pain, pain outcomes will be interpreted in conjunction with later postoperative assessments.