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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deksmedetomidine Group | Experimental | Patients receive 1 mcg/kg dexmedetomidine administered intravenously as a loading infusion over 10 minutes before spinal anesthesia. |
|
| Tramadol Group | Experimental | Patients receive 1 mg/kg tramadol administered intravenously as a loading infusion over 10 minutes before spinal anesthesia. |
|
| Placebo Comparator: Control Group | Placebo Comparator | Patients receive 10 mL of 0.9% saline intravenously over 10 minutes before spinal anesthesia as placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine administered intravenously as a 1 mcg/kg loading dose over 10 minutes before spinal anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (one day before surgery), immediately before spinal anesthesia on the day of surgery, and postoperative 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Score (VAS) | Postoperative pain assessed using the Visual Analog Scale (VAS) at 0, 4, and 12 hours after surgery. | 0, 4, and 12 hours after surgery |
| Intraoperative Hemodynamic Parameters |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Van Yuzuncu Yil University School of Medicine Department of Anesthesiology and Reanimation | Van | Tuşba | 65100 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D014147 | Tramadol |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Participants are randomly assigned to parallel groups to receive preoperative dexmedetomidine or tramadol before hemorrhoidectomy under spinal anesthesia.
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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.
| Tramadol | Drug | Tramadol administered intravenously as a 1 mg/kg loading dose over 10 minutes before spinal anesthesia. |
|
| 0.9 % saline | Drug | 10 mL of 0.9% saline administered intravenously over 10 minutes before spinal anesthesia. |
|
Systolic and diastolic blood pressure, heart rate, and oxygen saturation measured at 5-minute intervals during surgery.
| 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. | 0, 4, 12, and 24 hours after surgery |
| Additional Sedative Requirement | Total dose of midazolam administered intraoperatively for sedation. | 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. | 24 hours after surgery |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D003511 |
| Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |