]>
IRCT20230701058625N1 IRCT 2023-10-11 Dezfoul University of Medical Sciences Comparing the effectiveness of two treatment protocols: dexmedetomidine - propofol and midazolam - fentanyl - propofol in relieving pain in patients undergoing extracorporeal stone crusher Comparison of the effectiveness of two treatment protocols dexmedetomidine - propofol and midazolam - fentanyl - propofol in relieving pain in patients undergoing lithotomy 2023-10-02 anticipated 40 Complete https://irct.ir/trial/71036 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 40 patients who meet the criteria will enter the study and will be divided into two groups of 20 using computer random numbers. Group A, dexmedetomidine (a vial CC2mcg/200 diluted with CC50 normal saline and infused over 10 minutes, Blinding description: A nurse anesthetist who is not involved in this study will inject the drugs to the patients, then before and three hours after the operation, a blood sample will be taken by the researcher to measure P-Substance. None of the patients, as well as the researcher, will know what medicine was used for each patient. 4 Patients with Calculus of kidney. Intervention 1: Intervention group: Group A will receive dexmedetomidine (a vial CC2mcg/200 diluted with CC50 normal saline and infused over 10 minutes. This form of infusion will be repeated if needed) and propofol (0.5 mg/kg). Intervention 2: Intervention group: Group B will receive midazolam (0.025 mg/kg), fentanyl (1 mcg/kg) and propofol (0.5 mg/kg). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Still undecided - no release schedule yet
public Mehdi Rajaeipour
Justice corner, Post St., 15 Khordad Blvd., Dezful
Dezfoul Iran (Islamic Republic of) 6461669969 +98 916 641 0103 mehdi.rajaeipour@dums.ac.ir Dezfoul University of Medical Sciences scientific Mehdi Rajaeipour
Justice corner, Post St., 15 Khordad Blvd., Dezful
Dezfoul Iran (Islamic Republic of) 6461669969 +98 916 641 0103 mehdi.rajaeipour@dums.ac.ir Dezfoul University of Medical Sciences Iran (Islamic Republic of) Patients with kidney stones below 2cm and proximal ureter for ESWL aged 18 to 80 years with American Society of Anesthesiologists (ASA) physical status I, II or III who consent to participate in this study will be eligible for this study. 18 years 80 years Both Patients who do not agree to participate in this study Patients with chronic liver failure Patients who have a history of allergy to this drug or other alpha-adrenergic drugs Patients with a history of bradycardia and low blood pressure Patients with coagulation disorders Patients with a history of allergy to drugs used to treat ESWL Patients with mental disorders, nervous disorders and skin disorders (inflammation). Patients with active infection Patients who are pregnant Patients who have uremia Patients with BMI > 25 Patients who have used painkillers 12 hours before visiting Patients who have pain before visiting N20.0 Calculus of kidney Treatment - Drugs Treatment - Drugs Intervention group: Group A will receive dexmedetomidine (a vial CC2mcg/200 diluted with CC50 normal saline and infused over 10 minutes. This form of infusion will be repeated if needed) and propofol (0.5 mg/kg) Intervention group: Group B will receive midazolam (0.025 mg/kg), fentanyl (1 mcg/kg) and propofol (0.5 mg/kg). Plasma level of Substance P in patients. Timepoint: At the beginning of the study and one week after lithotomy of the patients. Method of measurement: Measuring the Plasma level with ELISA. Pain. Timepoint: At the beginning of the study and one week after lithotomy of the patients. Method of measurement: The person is shown a scale from 0 to 10 and the person gives a score from 0 to 10 on the level of pain felt. (Visual Analogue Scale). Blood pressure. Timepoint: Two times, before ESWL and one week after ESWL. Method of measurement: Manual sphygmomanometer. Respiratory rate. Timepoint: Two times, before ESWL and one week after ESWL. Method of measurement: clinical examination. Nausea and Vomiting. Timepoint: Two times, before ESWL and one week after ESWL. Method of measurement: Event occur. Dezfoul University of Medical Sciences Approved 2023-05-09 Research Ethics Committees of Dezful University of Medical Sciences Justice corner, Post St., 15 Khordad Blvd., Dezful Dezfoul Khouzestan Iran (Islamic Republic of)