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

NCT06860100 | Completed

• 1 other identifier: 19.11.2024/03
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Hemorrhoids; Perioperative Anxiety; Postoperative Pain

Keywords

hemorrhoidectomy; dexmedetomidine; tramadol; spinal anesthesia; perioperative anxiety; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Change in Perioperative STAI-State (STAI-S) Scores

  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 Outcomes (3)

• Postoperative Pain Score (VAS)

  Approximately 24 hours before surgery (baseline), immediately after surgery (0 hour), 12 hours after surgery, and 24 hours after surgery.

• Intraoperative Hemodynamic Parameters

  Baseline before spinal anesthesia and throughout surgery at predefined intraoperative measurement time points.

• Additional Sedative Requirement

  From initiation of spinal anesthesia to completion of surgery.

Study Arms (3)

Dexmedetomidine Group

EXPERIMENTAL

Patients receive dexmedetomidine 1 μg/kg administered intravenously over 10 minutes before saddle spinal anesthesia.

Drug: Dexmedetomidine

Tramadol Group

EXPERIMENTAL

Patients receive tramadol 1 mg/kg administered intravenously over 10 minutes before saddle spinal anesthesia.

Drug: Tramadol

Control Group

PLACEBO COMPARATOR

Patients receive 10 mL of 0.9% normal saline administered intravenously over 10 minutes before saddle spinal anesthesia.

Drug: 0.9 % Normal Saline

Interventions

Dexmedetomidine DRUG

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

Dexmedetomidine Group

Tramadol DRUG

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

Tramadol Group

0.9 % Normal Saline DRUG

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

Control Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 20 and 60 years ASA physical status I-II Scheduled for hemorrhoidectomy under spinal anesthesia Provided written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University School of Medicine Department of Anesthesiology and Reanimation

Van, Tuşba, 65100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemorrhoids; Pain, Postoperative

Interventions

Dexmedetomidine; Tramadol; Saline Solution

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The study is conducted in a double-blind manner. Study medications are prepared in identical opaque syringes by an anesthesiologist who is not involved in patient care, data collection, or outcome assessment. Participants, care providers and outcome assessors remain blinded to treatment allocation throughout the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor Doctor

Model Details: Participants are randomly assigned to one of three parallel groups to receive preoperative intravenous dexmedetomidine, tramadol, or placebo before elective hemorrhoidectomy performed under saddle spinal anesthesia.

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 5, 2025
• Study Start: November 17, 2025
• Primary Completion: June 30, 2026
• Study Completion: July 1, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

TU (1)