Clinical Trial

Dexmedetomidine vs Tramadol for Anxiety, Pain, and Hemodynamics in Hemorrhoidectomy

Study acronym: DEXTRA-H
Completed
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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. 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.
Protocol Amendment History 4 changes
critical Trial completed 2026-07-29
minor Completion moved earlier: 2026-09-01 -> 2026-07-01 2026-07-29
critical Primary endpoint(s) modified 2026-06-04
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-15
Trial Details
NCT Number NCT06860100
Lead Sponsor Yuzuncu Yil University
Conditions Hemorrhoids, Perioperative Anxiety, Postoperative Pain
Enrollment 90 participants
Start Date 2025-11-17
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-28