Comparison of Tramadol, Pethidine and Morphine in the Treatment of Pain After Thoracic Surgery

NCT06172920 | Unknown Phase 4

• 1 other identifier: KA23/137
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of analgesic effects of tramadol, aldolan and morphine under thoracic surgery

Conditions

Thoracic Diseases; Analgesia

Keywords

thoracic surgery; patient controlled analgesia; postoperative care unit; intensive care

Outcome Measures

Primary Outcomes (3)

• The rate of drugs's analgesic effects

  To compare the analgesic effects of tramadol, pethidine and morphine in the treatment of postoperative pain in thoracic surgery, It will be assesed with numeric rating scale ( 0= no pain, 10= worst pain imaginable)

  postoperative 24 hours

• Comparing hemodynamic effects

  To compare hemodynamic effects of tramadol, pethidine and morphine in the treatment of postoperative pain in thoracic surgery, It will be asssesed with measurements of intraoperative values of systolic, diastolic and mean arterial blood pressure

  Intraoperatively, then postoperative 24 hours

• Comparing respiratory effects

  To compare respiratory effects of tramadol, pethidine and morphine in the treatment of postoperative pain in thoracic surgery. It will be asssesed with postoperative pulmonary complications such as failed extubation, bronchospasms or respiratory depressions.

  postoperative 24 hours

Secondary Outcomes (3)

• Adverse effects of analgesics

  postoperative 24 hours

• surgeon satisfaction

  Immediately after the surgery

• patient satisfaction

  Postoperative 30th minute

Study Arms (3)

Tramadol

ACTIVE COMPARATOR

Tramadol receiving group

Drug: Tramadol hydrochloride

Aldolan

ACTIVE COMPARATOR

Aldolan receiving group

Drug: Aldolan

Morphine

ACTIVE COMPARATOR

Morphine receiving group

Drug: Morphine hydrochloride

Interventions

Tramadol hydrochloride DRUG

Patients are receiving tramadol hydrochloride under thoracic surgery

Tramadol

Aldolan DRUG

Patients are receiving meperidine under thoracic surgery

Aldolan

Morphine hydrochloride DRUG

Patients are receiving Morphine hydrochloride under thoracic surgery

Morphine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having non-urgent thoracic surgery
• over 18 years old
• Being in group I-III according to the American Society of Anesthesiologists (ASA) classification
• Not have allergies to the drugs to be used (volunteers with diseases that prevent the use of drugs will not be included in the study
• regardless of gender

You may not qualify if:

• Have allergies to the drugs to be used

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University Ankara Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Thoracic Diseases; Agnosia

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Central Study Contacts

Begum N Gokdemir, MD

CONTACT

03122036868; begokdemir@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Begüm Nemika Gökdemir, Research Assistant of Anesthesiology Department

Model Details: 3 groups of patients are received different type of analgesics

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: December 15, 2023
• Study Start: December 31, 2023
• Primary Completion: November 9, 2024
• Study Completion: December 9, 2024
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

TU (1)