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

July 26, 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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine Group
Patients receive dexmedetomidine 1 μg/kg administered intravenously over 10 minutes before saddle 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 tramadol 1 mg/kg administered intravenously over 10 minutes before saddle spinal anesthesia.
Drug: Tramadol
Tramadol administered intravenously as a 1 mg/kg loading dose over 10 minutes before spinal anesthesia.
Placebo Comparator: Control Group
Patients receive 10 mL of 0.9% normal saline administered intravenously over 10 minutes before saddle spinal anesthesia.
Drug: 0.9 % Normal 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 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative pain intensity assessed using the Visual Analog Scale (VAS) and compared among the three study groups.
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.
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.
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.
Total dose of rescue midazolam administered intraoperatively for sedation and compared among the three study groups.
From initiation of spinal anesthesia to completion of 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 (Actual)

June 30, 2026

Study Completion (Actual)

July 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)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 26, 2026

Last Verified

July 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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