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

May 11, 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 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • 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 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

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
Intervention / Treatment
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

Outcome Measure
Measure Description
Time Frame
Change in Preoperative Anxiety Level (STAI-S Score)
Time Frame: 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.
From baseline (one day before surgery) to immediately before spinal anesthesia on the day of surgery

Secondary Outcome Measures

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: 4, 12, and 24 hours after surgery
Postoperative pain assessed using the Visual Analog Scale (VAS) at 4, 12, and 24 hours after surgery.
4, 12, and 24 hours after surgery

Collaborators and Investigators

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

Sponsor

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)

November 17, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

March 1, 2025

First Posted (Actual)

March 5, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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