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

NCT06860100 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-07-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dexmedetomidine

Dexmedetomidine administered intravenously as a 1 mcg/kg loading dose over 10 minutes before spinal anesthesia.

DRUG

Tramadol

Tramadol administered intravenously as a 1 mg/kg loading dose over 10 minutes before spinal anesthesia.

DRUG

0.9 % Normal Saline

10 mL of 0.9% saline administered intravenously over 10 minutes before spinal anesthesia.

Sponsors & Collaborators

  • Yuzuncu Yil University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-17
Primary Completion
2026-06-30
Completion
2026-07-01

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06860100 on ClinicalTrials.gov