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IRCT20210216050377N1 IRCT 2022-01-16 Shahre-kord University of Medical Sciences The effect of silymarin on methadone poisoning Evaluation of the therapeutic effect of Silymarin in combination with naloxone in improving methadone poisoning 2021-05-19 anticipated 64 Complete https://irct.ir/trial/55314 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Poisoning by methadone. Intervention 1: Control group:This group includes people who have been exposed to methadone poisoning and have referred to Ayatollah Kashani Hospital in Shahrekord and have the inclusion criteria and receive only naloxane for treatment, so that after taking the initial serum sample, treatment measures are taken. We start and inject 0.4 mg of naloxone every 5 minutes once in non-addicted people and 0.05 mg or one-eighth ampoule every 5 minutes in addicted people (IV) to increase the oxygen saturation rate above 93%. And then the maintenance dose with two-thirds of the wake up dose (the dose with which the patient is awake or the respiratory depression is relieved) starts as an infusion per hour for the patient and lasts for 24 hours, then we start taper naloxone so that Every 6 hours, we halve the dose of naloxone received by the patient to reach zero, and since the half-life of methadone is about 25-52 hours, the patient should be monitored and up to 24 hours after discontinuation of naloxone if the patient has no symptoms and At the end of three days after starting treatment with naloxone , we took a second blood sample from the patient. Finally, we measure and compare all the initial variables in the before and after samples. Intervention 2: Intervention group: This group includes people who have suffered from methadone poisoning and have referred to Ayatollah Kashani Hospital in Shahrekord and have inclusion criteria and these people also receive silymarin in addition to naloxone for treatment. The prototype is taken and then the patient, in addition to receiving naloxone in the same way as the control group (0.4 mg naloxone once every 5 minutes in non-addicts and 0.05 mg or one-eighth ampoule once every 5 minutes in We inject addicts (IV) to increase the oxygen saturation to above 93%, and then the maintenance dose is started with an infusion of two-thirds of the wake up dose (the dose with which the patient is awake or the respiratory depression is gone) per hour for the patient to It lasts for 24 hours, then we start taper naloxone so that every 6 hours we halve the dose of naloxone received by the patient until it reaches zero, and since the half-life of methadone is about 52-25 hours, the patient should be monitored. And up to 24 hours after naloxone discontinuation if the patient has no symptoms Yilmarin, under the brand name of Livergel, receives the drug at a dose of 140 mg 3 times a day for 3 days. At the end of three days after starting treatment with naloxone and silymarin, we take a second blood sample from the patient and finally all the variables. We measure and compare the prototype in the before and after samples. 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 There is no more information
public Pantea Ramezan Nezhad
Ayatollah Kashani Hospital, Parastar Ave, Shahre-kord
Shahre-kord Iran (Islamic Republic of) 8816758915 0983832264825 ramezannezhad.p@skums.ac.ir Shahre-kord University of Medical Sciences scientific Pantea Ramezan Nezhad
Ayatollah Kashani Hospital, Parastar Ave, Shahre-kord
Shahre-kord Iran (Islamic Republic of) 8816758915 0983832264825 ramezannezhad.p@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) All patients with opioid triad include decreased level of consciousness, myotic pupil and decreased level of blood oxygen Methadone level is positive in their urine test (U / A) no limit no limit Both Patient dissatisfaction to participate in the study Use of supplements and drugs with similar effects or interventions with Naloxone and Silymarin T40.3X4 Poisoning by methadone, undetermined Treatment - Drugs Treatment - Drugs Control group:This group includes people who have been exposed to methadone poisoning and have referred to Ayatollah Kashani Hospital in Shahrekord and have the inclusion criteria and receive only naloxane for treatment, so that after taking the initial serum sample, treatment measures are taken. We start and inject 0.4 mg of naloxone every 5 minutes once in non-addicted people and 0.05 mg or one-eighth ampoule every 5 minutes in addicted people (IV) to increase the oxygen saturation rate above 93%. And then the maintenance dose with two-thirds of the wake up dose (the dose with which the patient is awake or the respiratory depression is relieved) starts as an infusion per hour for the patient and lasts for 24 hours, then we start taper naloxone so that Every 6 hours, we halve the dose of naloxone received by the patient to reach zero, and since the half-life of methadone is about 25-52 hours, the patient should be monitored and up to 24 hours after discontinuation of naloxone if the patient has no symptoms and At the end of three days after starting treatment with naloxone , we took a second blood sample from the patient. Finally, we measure and compare all the initial variables in the before and after samples Intervention group: This group includes people who have suffered from methadone poisoning and have referred to Ayatollah Kashani Hospital in Shahrekord and have inclusion criteria and these people also receive silymarin in addition to naloxone for treatment. The prototype is taken and then the patient, in addition to receiving naloxone in the same way as the control group (0.4 mg naloxone once every 5 minutes in non-addicts and 0.05 mg or one-eighth ampoule once every 5 minutes in We inject addicts (IV) to increase the oxygen saturation to above 93%, and then the maintenance dose is started with an infusion of two-thirds of the wake up dose (the dose with which the patient is awake or the respiratory depression is gone) per hour for the patient to It lasts for 24 hours, then we start taper naloxone so that every 6 hours we halve the dose of naloxone received by the patient until it reaches zero, and since the half-life of methadone is about 52-25 hours, the patient should be monitored. And up to 24 hours after naloxone discontinuation if the patient has no symptoms Yilmarin, under the brand name of Livergel, receives the drug at a dose of 140 mg 3 times a day for 3 days. At the end of three days after starting treatment with naloxone and silymarin, we take a second blood sample from the patient and finally all the variables. We measure and compare the prototype in the before and after samples. Serum level of Aspartate transaminase. Timepoint: Measurement of the variable before the intervention and 3 days after the intervention with silymarin. Method of measurement: They are measured on serum by commercial kits of Pars Azmoun company Italian BT3000 auto analyzer. Serum level of Alanine transaminase. Timepoint: Measurement of the variable before the intervention and 3 days after the intervention with silymarin. Method of measurement: They are measured on serum by commercial kits of Pars Azmoun company Italian BT3000 auto analyze. Serum level of Blood urea nitrogen. Timepoint: Measurement of the variable before the intervention and 3 days after the intervention with silymarin. Method of measurement: They are measured on serum by commercial kits of Pars Azmoun company Italian BT3000 auto analyze. Serum level of Creatinine. Timepoint: Measurement of the variable before the intervention and 3 days after the intervention with silymarin. Method of measurement: They are measured on serum by commercial kits of Pars Azmoun company Italian BT3000 auto analyze. Serum level of Uric Acid. Timepoint: Measurement of the variable before the intervention and 3 days after the intervention with silymarin. Method of measurement: They are measured on serum by commercial kits of Pars Azmoun company Italian BT3000 auto analyze. Serum level of Lactate dehydrogenase. Timepoint: Measurement of the variable before the intervention and 3 days after the intervention with silymarin. Method of measurement: They are measured on serum by commercial kits of Pars Azmoun company Italian BT3000 auto analyze. Serum level of Creatine phosphokinase. Timepoint: Measurement of the variable before the intervention and 3 days after the intervention with silymarin. Method of measurement: They are measured on serum by commercial kits of Pars Azmoun company Italian BT3000 auto analyze. Serum level of Sodium. Timepoint: Measurement of the variable before the intervention and 3 days after the intervention with silymarin. Method of measurement: They are measured on serum by commercial kits of Pars Azmoun company Italian BT3000 auto analyze. Serum level of Potassium. Timepoint: Measurement of the variable before the intervention and 3 days after the intervention with silymarin. Method of measurement: They are measured on serum by commercial kits of Pars Azmoun company Italian BT3000 auto analyze. Ferric reducing ability of plasma(FRAP). Timepoint: Measurement of the variable before the intervention and 3 days after the intervention with silymarin. Method of measurement: In the FRAP method, triazine reagent is added to the serum sample and the resulting mixture is incubated for 10 minutes at 37 ° C and then the absorbance of the solution is measured at 593 nm by a spectrophotometer. Level of Venues blood Hydrogen Bicarbonate. Timepoint: Measurement of the variable before the intervention and 3 days after the intervention with silymarin. Method of measurement: Blood gas analyzer. Level of blood venous oxygen pressure. Timepoint: Measurement of the variable before the intervention and 3 days after the intervention with silymarin. Method of measurement: Blood gas analyzer. Level of venoues blood Carbon dioxide. Timepoint: Measurement of the variable before the intervention and 3 days after the intervention with silymarin. Method of measurement: Blood gas analyzer. Venoues blood acidity(PH). Timepoint: Measurement of the variable before the intervention and 3 days after the intervention with silymarin. Method of measurement: Blood gas analyzer. Serum level of Malon dialdehyde(MDA). Timepoint: Measurement of the variable before the intervention and 3 days after the intervention with silymarin. Method of measurement: To 50 μl of serum, 50 μl of 0.05% solution of BHT (Butylated hydroxytoluene) in 0.95% ethanol, 400 μl of 0.44 mM phosphoric acid and 100 μl of 42 mM thiobarbituric acid solution (TBA) is added for 1 hour. It is incubated at 100 ° C and then the samples are placed on ice for 5 minutes and then the absorptions are read by spectrophotometer. Blood pressure. Timepoint: Measurement of the variable before the intervention and 3 days after the intervention with silymarin. Method of measurement: Use of mercury sphygmomanometer. Heart rate. Timepoint: Measurement of the variable before the intervention and 3 days after the intervention with silymarin. Method of measurement: Use of pulse oximeter. Respiratory rate. Timepoint: Measurement of the variable before the intervention and 3 days after the intervention with silymarin. Method of measurement: Count chest movements in one minute. Body temperature. Timepoint: Measurement of the variable before the intervention and 3 days after the intervention with silymarin. Method of measurement: Using a mercury thermometer. Shahre-kord University of Medical Sciences Approved 2021-05-11 Ethics committee of Shahrekord University of Medical Sciences No3, 41 Ave, Parastar Blvd, Shahrekord Town, Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)