Hemorrhoids, Perioperative Anxiety, Postoperative Pain
Conditions
Keywords
hemorrhoidectomy, dexmedetomidine, tramadol, spinal anesthesia, perioperative anxiety, postoperative pain
Brief summary
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.
Detailed description
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.
Interventions
DRUGDexmedetomidine
Dexmedetomidine administered intravenously as a 1 mcg/kg loading dose over 10 minutes before spinal anesthesia.
DRUGTramadol
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.
Sponsors
Yuzuncu Yil University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants are randomly assigned to one of three parallel groups to receive preoperative intravenous dexmedetomidine, tramadol, or placebo before elective hemorrhoidectomy performed under saddle spinal anesthesia.
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perioperative STAI-State (STAI-S) Scores | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score (VAS) | Approximately 24 hours before surgery (baseline), immediately after surgery (0 hour), 12 hours after surgery, and 24 hours after surgery. | Postoperative pain intensity assessed using the Visual Analog Scale (VAS) and compared among the three study groups. |
| Intraoperative Hemodynamic Parameters | Baseline before spinal anesthesia and throughout surgery at predefined intraoperative measurement time points. | Systolic, diastolic, and mean arterial blood pressure, heart rate, and peripheral oxygen saturation recorded at baseline before spinal anesthesia and at predefined intraoperative measurement time points and compared among the three study groups. |
| Additional Sedative Requirement | From initiation of spinal anesthesia to completion of surgery. | Total dose of rescue midazolam administered intraoperatively for sedation and compared among the three study groups. |
Countries
Turkey (Türkiye)
Outcome results
None listed