A Randomized Double-Blind Study Comparing the Effects of Preoperative Dexmedetomidine Versus Tramadol on Anxiety, Pain, and Hemodynamics in Patients Undergoing Hemorrhoidectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Perioperative STAI-State (STAI-S) Scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The study is conducted in a double-blind manner. Study medications are prepared in identical opaque syringes by an anesthesiologist who is not involved in patient care, data collection, or outcome assessment. Participants, care providers and outcome assessors remain blinded to treatment allocation throughout the study period.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 20 and 60 years ASA physical status I-II Scheduled for hemorrhoidectomy under spinal anesthesia Provided written informed consent
排除标准
- •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
研究组 & 干预措施
Control Group
Patients receive 10 mL of 0.9% normal saline administered intravenously over 10 minutes before saddle spinal anesthesia.
干预措施: 0.9 % Normal Saline (Drug)
Dexmedetomidine Group
Patients receive dexmedetomidine 1 μg/kg administered intravenously over 10 minutes before saddle spinal anesthesia.
干预措施: Dexmedetomidine (Drug)
Tramadol Group
Patients receive tramadol 1 mg/kg administered intravenously over 10 minutes before saddle spinal anesthesia.
干预措施: Tramadol (Drug)
结局指标
主要结局
Change in Perioperative STAI-State (STAI-S) Scores
时间窗: Baseline (approximately 24 hours before surgery), after study drug infusion before spinal anesthesia, immediately after surgery, 12 hours after surgery, and 24 hours after surgery.
Evaluation of changes in State-Trait Anxiety Inventory-State (STAI-S) scores over time among the three study groups, including group effect, time effect, and group-by-time interaction.
次要结局
- Postoperative Pain Score (VAS)(Approximately 24 hours before surgery (baseline), immediately after surgery (0 hour), 12 hours after surgery, and 24 hours after surgery.)
- Intraoperative Hemodynamic Parameters(Baseline before spinal anesthesia and throughout surgery at predefined intraoperative measurement time points.)
- Additional Sedative Requirement(From initiation of spinal anesthesia to completion of surgery.)
研究者
Arzu Esen Tekeli
Associated Professor Doctor
Yuzuncu Yil University