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

NCT06860100 | Recruiting

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

Brief Summary

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.

Conditions

Hemorrhoids; Perioperative Anxiety; Postoperative Pain

Keywords

analgesia; sedation; perioperative anxiety; intraoperative hemodynamics

Outcome Measures

Primary Outcomes (1)

• Change in Preoperative Anxiety Level (STAI-S Score)

  Change in State-Trait Anxiety Inventory-State (STAI-S) scores from baseline (one day before surgery) to immediately before spinal anesthesia on the day of surgery among study groups.

  From baseline (one day before surgery) to immediately before spinal anesthesia on the day of surgery

Secondary Outcomes (5)

• Postoperative Pain Score (VAS)

  0, 4, 12, and 24 hours after surgery

• Intraoperative Hemodynamic Parameters

  During surgery, measured at 5-minute intervals

• Sedation Level (Ramsay Sedation Scale)

  0, 4, 12, and 24 hours after surgery

• Additional Sedative Requirement

  From initiation of spinal anesthesia until the end of surgery

• Postoperative Anxiety Level (STAI-S Score)

  24 hours after surgery

Study Arms (3)

Deksmedetomidine Group

EXPERIMENTAL

Patients receive 1 mcg/kg dexmedetomidine administered intravenously as a loading infusion over 10 minutes before spinal anesthesia.

Drug: Dexmedetomidine

Tramadol Group

EXPERIMENTAL

Patients receive 1 mg/kg tramadol administered intravenously as a loading infusion over 10 minutes before spinal anesthesia.

Drug: Tramadol

Control Group

NO INTERVENTION

Patients receive no preoperative sedative or analgesic medication before spinal anesthesia.

Interventions

Dexmedetomidine DRUG

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

Deksmedetomidine Group

Tramadol DRUG

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

Tramadol 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)

RECRUITING

MeSH Terms

Conditions

Hemorrhoids; Pain, Postoperative; Agnosia

Interventions

Dexmedetomidine; Tramadol

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; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Central Study Contacts

Arzu Esen Tekeli, MD

CONTACT

+905053756375; esentekeli190807@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is conducted in a double-blind manner. Participants and outcome assessors are blinded to group allocation. The investigator responsible for outcome assessment is unaware of the intervention administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor Doctor

Model Details: Participants are randomly assigned to parallel groups to receive preoperative dexmedetomidine or tramadol before hemorrhoidectomy under spinal anesthesia.

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 5, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

TU (1)