Hemorrhoids, Perioperative Anxiety, Postoperative Pain
Conditions
Keywords
analgesia, sedation, perioperative anxiety, intraoperative hemodynamics
Brief summary
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.
Detailed 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 receive 10 mL of 0.9% saline intravenously over 10 minutes before spinal anesthesia as placebo. 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.
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.
DRUG0.9 % saline
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
DOUBLE (Subject, Outcomes Assessor)
Masking description
The study is conducted in a double-blind manner. Study medications are prepared in identical opaque syringes by an anesthesiologist not involved in outcome assessment. Participants and investigators responsible for perioperative assessments are blinded to group allocation throughout the study period.
Intervention model description
Participants are randomly assigned to parallel groups to receive preoperative dexmedetomidine or tramadol before hemorrhoidectomy under 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 Preoperative Anxiety Level (STAI-S Score) | From baseline (one day before surgery) to immediately before spinal anesthesia on the day of surgery | Evaluation of changes in STAI-State (STAI-S) scores over time with respect to group effect, time effect, and group × time interaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score (VAS) | 4, 12, and 24 hours after surgery | Postoperative pain assessed using the Visual Analog Scale (VAS) at 4, 12, and 24 hours after surgery. |
| Intraoperative Hemodynamic Parameters | During surgery, measured at 5-minute intervals | Systolic and diastolic blood pressure, heart rate, and oxygen saturation measured at 5-minute intervals during surgery. |
| Sedation Level (Ramsay Sedation Scale) | 0, 4, 12, and 24 hours after surgery | Sedation level assessed using the Ramsay Sedation Scale at 0, 4, 12, and 24 hours after surgery among study groups. |
| Additional Sedative Requirement | From initiation of spinal anesthesia until the end of surgery | Total dose of midazolam administered intraoperatively for sedation. |
| Postoperative Anxiety Level (STAI-S Score) | 24 hours after surgery | State-Trait Anxiety Inventory-State (STAI-S) score assessed postoperatively when Ramsay Sedation Score is ≤3 among study groups. |
Countries
Turkey (Türkiye)
Outcome results
None listed