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IRCT20210222050462N1 IRCT 2022-01-13 Shahre-kord University of Medical Sciences The Evaluation of the Effect of N-acetylcysteine in Improving Methadone Poisoning The Evaluation of the Effect of N-acetylcysteine ​​Combined With Therapeutic Effect of Naloxone in Improving Methadone Poisoning 2021-05-20 anticipated 64 Complete https://irct.ir/trial/55313 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Poisoning by Methadone. Intervention 1: Intervention group:In this group, treatment performed by using Naloxone and N-acetylcysteine ​​. N-acetylcysteine ​​is applied in therapeutic doses which used in acetaminophen poisoning, with the initial injection dose of N-acetylcysteine ​​being infused at 150 mg / kg in 200 cc of 5% dextrose within 1 hour, followed by 50 mg / kg immediately is infused in 500 cc of 5% dextrose for 4 hours and immediately after that 100 mg / Kg in one liter of 5% dextrose is infused for 16 hours. Therapeutic intervention with 0.4 mg injectable dose of naloxone in non-addicts and 0.05 mg in addicts is administered every 5 minutes until the patient's concentration reaches above 93% and then the maintenance dose with 2.3 doses of wake up (dose that the patient with It wakes up or the patient's respiratory depression resolves) starts per hour for the patient and lasts up to 24 hours, and then we start taper naloxone so that every 6 hours we halve the dose of naloxone received by the patient to zero and eventually 5 days after beginning of treatment, blood samples are taken from patients again.Finally, all variables are compared separately in two groups of case and control to determine the effect of N-acetylcysteine. Intervention 2: Control group:In the control group, treatment performed just by Naloxone . Intervention therapy with 0.4 mg injectable dose of naloxone in non-addicts and 0.05 mg in addicts is administered every 5 minutes until the patient's concentration reaches above 93% and then the maintenance dose It starts with 2/3 dose of wake up (the dose that the patient wakes up with or the patient's respiratory depression goes away) per hour for the patient and continues for 24 hours and then we start taper naloxone so that every 6 hours the dose We halve the naloxone intake of the patient to zero and finally, after 5 days from the start of treatment,Blood samples are taken from the patient again. Finally, all variables are compared separately in case and control groups to determine the effect of N-acetylcysteine. 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 Pante A Ramezannezhad
Parastar Ave ;Ayatollah Kashani Hospital
Shahrekord Iran (Islamic Republic of) 8816758915 0098 38 32264825-41 ramezannezhad.p@skums.ac.ir Shahre-kord University of Medical Sciences scientific Pante A ramezannezhad
Kashani hospital;Parastar avenue
Shahrekord Iran (Islamic Republic of) 8816758915 0098 38 32264825-41 ramezannezhad.p@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) All patients who have a triad of opioid poisoning, including: loss of consciousness, hypoxia and Myotic pupil Have a positive methadone level in urinalysis (UA) no limit no limit Both Patient dissatisfaction Subjects who use supplements and drugs with similar effects or interfering with Naloxone and N-acetylcysteine T40.3X4 Poisoning by Methadone, undetermined Treatment - Drugs Treatment - Drugs Intervention group:In this group, treatment performed by using Naloxone and N-acetylcysteine ​​. N-acetylcysteine ​​is applied in therapeutic doses which used in acetaminophen poisoning, with the initial injection dose of N-acetylcysteine ​​being infused at 150 mg / kg in 200 cc of 5% dextrose within 1 hour, followed by 50 mg / kg immediately is infused in 500 cc of 5% dextrose for 4 hours and immediately after that 100 mg / Kg in one liter of 5% dextrose is infused for 16 hours. Therapeutic intervention with 0.4 mg injectable dose of naloxone in non-addicts and 0.05 mg in addicts is administered every 5 minutes until the patient's concentration reaches above 93% and then the maintenance dose with 2.3 doses of wake up (dose that the patient with It wakes up or the patient's respiratory depression resolves) starts per hour for the patient and lasts up to 24 hours, and then we start taper naloxone so that every 6 hours we halve the dose of naloxone received by the patient to zero and eventually 5 days after beginning of treatment, blood samples are taken from patients again.Finally, all variables are compared separately in two groups of case and control to determine the effect of N-acetylcysteine. Control group:In the control group, treatment performed just by Naloxone . Intervention therapy with 0.4 mg injectable dose of naloxone in non-addicts and 0.05 mg in addicts is administered every 5 minutes until the patient's concentration reaches above 93% and then the maintenance dose It starts with 2/3 dose of wake up (the dose that the patient wakes up with or the patient's respiratory depression goes away) per hour for the patient and continues for 24 hours and then we start taper naloxone so that every 6 hours the dose We halve the naloxone intake of the patient to zero and finally, after 5 days from the start of treatment,Blood samples are taken from the patient again. Finally, all variables are compared separately in case and control groups to determine the effect of N-acetylcysteine. Serum levels of Aspartate aminotransferase enzyme. Timepoint: Measurement of the variable before intervening and 5 days after beginning the treatment with N-acetylcysteine. Method of measurement: Measured by Pars Azmoun commercial kitson on blood serum with an autoanalyzer system (BT3000, Italy). Serum levels of Alanine transaminase. Timepoint: Measurement of the variable before intervening and 5 days after beginning the treatment with N-acetylcysteine. Method of measurement: By Pars Azmoun commercial kits Measured on blood serum with an autoanalyzer system (BT3000, Italy). Serum levels of Blood urea Nitrogen. Timepoint: Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine. Method of measurement: Measured by Pars Azmoun commercial kits on blood serum with an autoanalyzer system(BT3000, Italy). Serum levels of Creatinine. Timepoint: Measurement of the variable before tntervening and 5 days after beginning of treatment with N-acetylcysteine. Method of measurement: Measured by Pars Azmoun commercial kits on blood serum with an autoanalyzer system (BT3000, Italy). Serum levels of Uric acid. Timepoint: Measurement of the variable before the intervening and 5 days after beginning treatment with N-acetylcysteine. Method of measurement: By Pars Azmoun commercial kits Measured on blood serum with an autoanalyzer system(BT3000, Italy). Serum levels of Malondialdehyde. Timepoint: Measurement of the variable before the intervention and 5 days after the beginning treatment with N-acetylcysteine. 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. The temperature is incubated at 100 ° C and then the samples are placed on ice for 5 minutes and then the absorptions are read with a spectrophotometer. Serum levels of Lactate dehydrogenase. Timepoint: Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine. Method of measurement: By Pars Azmoun commercial kits Measured on blood serum with an autoanalyzer (BT3000, Italy). Serum levels of ferric reducing ability of plasma(FRAP). Timepoint: Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine. 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. Then the absorbance of the solution is measured at a wavelength of 593 nm by a spectrophotometer. Blood pressure. Timepoint: Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine. Method of measurement: Mercury sphygmomanometer. Heart rate. Timepoint: Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine. Method of measurement: Pulse oximeter. Respiratory rate. Timepoint: Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine. Method of measurement: Count the number of breaths by observing the movements of the chest. Body Temperature. Timepoint: Measurement of the variable before the intervening and 5 days after beginning of treatment with N-acetylcysteine. Method of measurement: Mercury Therommeter. Serum levels of Creatine phosphokinase. Timepoint: Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine. Method of measurement: By Pars Azmoun commercial kits Measured on blood serum with an autoanalyzer (BT3000, Italy). Serum levels of sodium. Timepoint: Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine. Method of measurement: By Pars Azmoun commercial kits Measured on blood serum with an autoanalyzer (BT3000, Italy). Serum levels of potassium. Timepoint: Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine. Method of measurement: By Pars Azmoun commercial kits Measured on blood serum with an autoanalyzer (BT3000, Italy). Venous blood pH. Timepoint: Measurement of the variable before the intervening and 5 days after beginning of treatment with N-acetylcysteine. Method of measurement: Blood gas analyzer. Venous blood levels of Partial oxygen pressure (PO2). Timepoint: Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine. Method of measurement: Blood gas analyzer. Venous blood levels of Partial pressure of carbon dioxide (PCO2). Timepoint: Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine. Method of measurement: Blood gas analyzer. Venous blood levels of Bicarbonate ion (̄ HCO3). Timepoint: Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine. Method of measurement: Blood gas analyzer. Shahre-kord University of Medical Sciences Approved 2021-02-09 Ethics committee of Shahrekord university of medical sciences Parastar Ave ;Ayatollah Kashani Hospital Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)