Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06040853
Other study ID # traneksamicanalgesia
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date September 30, 2023
Est. completion date March 30, 2024

Study information

Verified date September 2023
Source Dr. Lutfi Kirdar Kartal Training and Research Hospital
Contact gülten arslan, Assoc prof
Phone +905323620366
Email gulten.arslan@yahoo.com.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prostate cancer is the most diagnosed cancer among men today. Radical prostatectomy is a surgery that significantly reduces disease-related mortality. The laparoscopic technique, on the other hand, is preferred because it shortens the hospital stay, faster recovery and less postoperative pain.In this study, it was planned to investigate the analgesic or hyperalgesic effects of tranexamic acid, which is widely used in the management of bleeding in trauma, orthopedic, genitourinary and gynecological surgeries. Routine noninvasive monitoring (ECG, Spo2, NIBP) will be performed when participatient are taken to the operating table without premedication. After midazolam is administered, intubation will be performed by administering 1mg/kg lidocaine, 3mg/kg propofol, 2mcg/kg fentanyl, 0.6mg/kg rocuronium. Anesthesia will be maintained with desflurane with a MAC of 1. A 0.1-0.5 mcg/kg/min remifentanil infusion will be administered by targeting 40-60 values with BIS monitoring. After intubation, 15mg/kg tranexamic acid will be given 10 minutes before the incision, and 100 mg/h infusion will be administered until the skin is closed. The control group will be given 100 ml of saline.1mg/kg tramadol and 1gr parol will be administered 30 minutes before the end of the operation. The primary objectives of the study were to learn the VAS (Visual analog scale) score at 0.6,12, 24,48,72 hours, time to first analgesic requirement, and analgesic requirement within 24 hours. Secondary purposes are to determine the amount of antiemetic used, at the beginning of the operation, Hg at the first hour and postoperative 6 hours, complications and side effects (such as DVT, pulmonary embolism).


Description:

Prostate cancer is the most diagnosed cancer among men today. Radical prostatectomy is a surgery that significantly reduces disease-related mortality. The laparoscopic technique, on the other hand, is preferred because it shortens the hospital stay, faster recovery and less postoperative pain.In this study, it was planned to investigate the analgesic or hyperalgesic effects of tranexamic acid, which is widely used in the management of bleeding in trauma, orthopedic, genitourinary and gynecological surgeries


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date March 30, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Elective laparoscopic radical prostatectomy will be performed; Surgeon with more than 10 years of laparoscopic prostatectomy experience - Participant BMI(weight/height2)(kg/m2)<35 - ASA2-3 - Participant Age>18 - Participant Age<75 Exclusion Criteria: - Coagulation disorder, - Chronic renal failure, - Patients allergic to tranexamic acid, - Participant Age<18 - Participant Age>75, - Participant BMI(weight/height2)(kg/m2)>35, - Surgeon with less than 10 years of laparoscopic prostatectomy experience, - Patients who had a cerebral, coronary and thromboembolic event within 6 months before the operation

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tranexamic acid intravenous administration
Participants will be given 15mg/kg tranexamic acid before the incision in ten minutes, 100 mg/h will continue until the end of the surgery.
Saline
Participant was given intravenous 100 ml saline

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Dr. Lutfi Kirdar Kartal Training and Research Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analog scale, time of first analgesic requirement, used within 24 hours amount of analgesic, Investigators will evaluate VAS score, time of first analgesic requirement, used within 24 hours amount of analgesic, Change from baseline at 0., 6., 12., 24., 48., 72. hours VAS score
Secondary side effect, 0., 1., 6. hours hemogram value, amount of antiemetic used Investigators will evaluate demographic characteristics [years, female/male, weight(kg),height(meter), BMI (kg/m2 )], side effect, 0,1,6 st hour hemogram value, amount of antiemetic used. Change from baseline at 0., 1., 6. hours
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05553496 - Assessment of Rituximab Therapeutic Response Versus Conventional Treatment Phase 2/Phase 3
Recruiting NCT05534802 - Ulinastatin Improves and Prevents Cardiac Dysfunction Induced by Cardiopulmonary Bypass N/A
Recruiting NCT04190537 - PARADOX - the Incidence of Paradoxical Reactions in Pediatric Patients Premedicated With Midazolam
Completed NCT03522532 - Dental Restorations Effect on Oxidative Status of the Gingival Crevicular Fluid N/A
Completed NCT03119454 - "Corticoid-16" in Long Term When Administered Systemically in Patients in Routine Medical Practice N/A
Unknown status NCT01614353 - Medication-taking Preferences & Practices of Patients With Chronic Conditions N/A
Completed NCT03714360 - The Effect of Tranexamic Acid. A Randomised Study of Patients Undergoing Elective Lumbar Spine Surgery. Phase 4
Recruiting NCT03352622 - Pharmacogenomic in Colombian Patients With Rheumatoid Arthritis N/A
Recruiting NCT06288841 - Efficacy and Safety of Liposomal Bupivacaine Under ERAS Concept for Postoperative Analgesia of Ultrasound-Guided QLB in Gynecologic Laparoscopic Patients: A Randomized, Single-blind, Active-Controlled Clinical Study N/A
Not yet recruiting NCT04320277 - Baricitinib in Symptomatic Patients Infected by COVID-19: an Open-label, Pilot Study. Phase 2/Phase 3
Completed NCT03359590 - Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients Phase 2
Completed NCT05591105 - Morphine Consumption in the Obese Patients
Not yet recruiting NCT03904303 - Test of a New Gel-based Colon Cleansing Agent Compared to Moviprep Phase 1
Not yet recruiting NCT05453045 - Pharmacokinetics and Excretion of Albendazole and Its Metabolites in Saliva N/A
Completed NCT05428683 - Intravitreal Triamcinolone and Moxifloxacin Injection After Cataract Surgery N/A
Enrolling by invitation NCT02985281 - Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Therapy in Pediatric Patients Phase 2/Phase 3
Recruiting NCT06222710 - Ultrasound Guiding Pharmacopuncture Therapy for Supraspinatus Tendinopathy N/A
Not yet recruiting NCT03953287 - Pharmacokinetic Study of Paracetamol. Phase 1
Recruiting NCT03622047 - Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil N/A
Active, not recruiting NCT06324370 - Exploratory Pharmacokinetic Study of Virgin Coconut Oil (VCO) N/A