Dexmedetomidine vs Tramadol for Anxiety, Pain, and Hemodynamics in Hemorrhoidectomy (DEXTRA-H)

June 1, 2026 updated by: Arzu Esen Tekeli, Yuzuncu Yil University

A Randomized Double-Blind Study Comparing the Effects of Preoperative Dexmedetomidine Versus Tramadol on Anxiety, Pain, and Hemodynamics in Patients Undergoing Hemorrhoidectomy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Tuşba
      • Van, Tuşba, Turkey (Türkiye), 65100
        • Van Yuzuncu Yil University School of Medicine Department of Anesthesiology and Reanimation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Study Population

Elective haemorrhoidectomy surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Deksmedetomidine Group
Patients receive 1 mcg/kg dexmedetomidine administered intravenously as a loading infusion over 10 minutes before spinal anesthesia.
Drug: Dexmedetomidine
Dexmedetomidine administered intravenously as a 1 mcg/kg loading dose over 10 minutes before spinal anesthesia.
Experimental: Tramadol Group
Patients receive 1 mg/kg tramadol administered intravenously as a loading infusion over 10 minutes before spinal anesthesia.
Drug: Tramadol
Tramadol administered intravenously as a 1 mg/kg loading dose over 10 minutes before spinal anesthesia.
Placebo Comparator: Placebo Comparator: Control Group
Patients receive 10 mL of 0.9% saline intravenously over 10 minutes before spinal anesthesia as placebo.
Drug: 0.9 % saline
10 mL of 0.9% saline administered intravenously over 10 minutes before spinal anesthesia.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Perioperative STAI-State (STAI-S) Scores
Time Frame: Baseline (one day before surgery), immediately before spinal anesthesia on the day of surgery, and postoperative 24 hours
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intraoperative Hemodynamic Parameters
Time Frame: During surgery, measured at 5-minute intervals
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)
Time Frame: 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.
0, 4, 12, and 24 hours after surgery
Additional Sedative Requirement
Time Frame: From initiation of spinal anesthesia until the end of surgery
Total dose of midazolam administered intraoperatively for sedation.
From initiation of spinal anesthesia until the end of surgery
Postoperative Anxiety Level (STAI-S Score)
Time Frame: 24 hours after surgery
State-Trait Anxiety Inventory-State (STAI-S) score assessed postoperatively when Ramsay Sedation Score is ≤3 among study groups.
24 hours after surgery
Postoperative Pain Score (VAS)
Time Frame: 0, 4, and 12 hours after surgery
Postoperative pain assessed using the Visual Analog Scale (VAS) at 0, 4, and 12 hours after surgery.
0, 4, and 12 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yuzuncu Yil University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19.11.2024/03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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