HemorrhoidsDEXTRA-HNCT06860100
Dexmedetomidine vs Tramadol for Anxiety, Pain, and Hemodynamics in Hemorrhoidectomy
A study testing Dexmedetomidine, Tramadol and 0.9 % Normal Saline in people with Hemorrhoids and Perioperative Anxiety, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Hemorrhoids, Perioperative Anxiety, Postoperative Pain
- What is being tested?
- Dexmedetomidine, Tramadol and 0.9 % Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Nov 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged between 20 and 60 years ASA physical status I-II Scheduled for hemorrhoidectomy under spinal anesthesia Provided written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yuzuncu Yil University School of Medicine Department of Anesthesiology and Reanimation
Van, Tuşba, 65100
About this study
Official title: A Randomized Double-Blind Study Comparing the Effects of Preoperative Dexmedetomidine Versus Tramadol on Anxiety, Pain, and Hemodynamics in Patients Undergoing Hemorrhoidectomy
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.
Read the 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.
- Conditions
- Hemorrhoids, Perioperative Anxiety, Postoperative Pain
- Being tested
- Dexmedetomidine, Tramadol, 0.9 % Normal Saline
- Keywords
- hemorrhoidectomy, dexmedetomidine, tramadol, spinal anesthesia, perioperative anxiety, postoperative pain
- Medical subject headings
- Hemorrhoids, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine administered intravenously as a 1 mcg/kg loading dose over 10 minutes before spinal anesthesia.
TramadolDrug
Tramadol administered intravenously as a 1 mg/kg loading dose over 10 minutes before spinal anesthesia.
0.9 % Normal SalineDrug
10 mL of 0.9% saline administered intravenously over 10 minutes before spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Experimental | Patients receive dexmedetomidine 1 μg/kg administered intravenously over 10 minutes before saddle spinal anesthesia. Receives: Drug: Dexmedetomidine |
| Tramadol Group | Experimental | Patients receive tramadol 1 mg/kg administered intravenously over 10 minutes before saddle spinal anesthesia. Receives: Drug: Tramadol |
| Control Group | Placebo comparator | Patients receive 10 mL of 0.9% normal saline administered intravenously over 10 minutes before saddle spinal anesthesia. Receives: Drug: 0.9 % Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perioperative STAI-State (STAI-S) Scores
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.
Measured: 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.
Secondary outcomes (3)
Postoperative Pain Score (VAS)
Postoperative pain intensity assessed using the Visual Analog Scale (VAS) and compared among the three study groups.
Measured: Approximately 24 hours before surgery (baseline), immediately after surgery (0 hour), 12 hours after surgery, and 24 hours after surgery.
Intraoperative Hemodynamic Parameters
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.
Measured: Baseline before spinal anesthesia and throughout surgery at predefined intraoperative measurement time points.
Additional Sedative Requirement
Total dose of rescue midazolam administered intraoperatively for sedation and compared among the three study groups.
Measured: From initiation of spinal anesthesia to completion of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start17 Nov 2025
- Primary completion30 Jun 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Esen Tekeli, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860100
- Sponsor's protocol ID
- 19.11.2024/03
- Acronym
- DEXTRA-H
- Status last verified
- Jul 2026
- First submitted
- 24 Feb 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Study Comparing the Effects of Preoperative Dexmedetomidine Versus Tramadol on Anxiety, Pain, and Hemodynamics in Patients Undergoing Hemorrhoidectomy
- ClinicalTrials.gov ID
- NCT06860100
- Acronym / sponsor ID
- DEXTRA-H / 19.11.2024/03
- Conditions
- Hemorrhoids, Perioperative Anxiety, Postoperative Pain
- Keywords
- hemorrhoidectomy, dexmedetomidine, tramadol, spinal anesthesia, perioperative anxiety, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Experimental | Drug: DexmedetomidinePatients receive dexmedetomidine 1 μg/kg administered intravenously over 10 minutes before saddle spinal anesthesia. |
| Tramadol Group | Experimental | Drug: TramadolPatients receive tramadol 1 mg/kg administered intravenously over 10 minutes before saddle spinal anesthesia. |
| Control Group | Placebo comparator | Drug: 0.9 % Normal SalinePatients receive 10 mL of 0.9% normal saline administered intravenously over 10 minutes before saddle spinal anesthesia. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aged between 20 and 60 years ASA physical status I-II Scheduled for hemorrhoidectomy under spinal anesthesia Provided written informed consent
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineDexmedetomidine administered intravenously as a 1 mcg/kg loading dose over 10 minutes before spinal anesthesia. | Drug | Dexmedetomidine Group |
| TramadolTramadol administered intravenously as a 1 mg/kg loading dose over 10 minutes before spinal anesthesia. | Drug | Tramadol Group |
| 0.9 % Normal Saline10 mL of 0.9% saline administered intravenously over 10 minutes before spinal anesthesia. | Drug | Control Group |
Primary outcome
Change in Perioperative STAI-State (STAI-S) Scores
Time frame: 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.
3 secondary outcomes
Postoperative Pain Score (VAS)
Time frame: Approximately 24 hours before surgery (baseline), immediately after surgery (0 hour), 12 hours after surgery, and 24 hours after surgery.
Intraoperative Hemodynamic Parameters
Time frame: Baseline before spinal anesthesia and throughout surgery at predefined intraoperative measurement time points.
Additional Sedative Requirement
Time frame: From initiation of spinal anesthesia to completion of surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, Tramadol and 0.9 % Normal Saline in people with Hemorrhoids and Perioperative Anxiety, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perioperative STAI-State (STAI-S) Scores (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.