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IRCT20230405057824N1 IRCT 2023-09-05 Islamic Azad University Comparison of the effect of use of preoperative mexiletine tablets and placebo on reducing postoperative pain in patients undergoing abdominal surgery in Tehran Azad University hospitals in 2021-2023 Comparison of the effect of use of preoperative mexiletine tablets and placebo on reducing postoperative pain in patients undergoing abdominal surgery 2022-08-23 anticipated 34 Complete https://irct.ir/trial/69439 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, a list of all patients who were willing to participate in the study was first prepared, and after matching the patients who met the inclusion criteria, we assigned a number to each patient. We considered numbers 1 to 17 as group A and 18 to 34 as group B. Then, using an online random number table, the patients were placed in two groups (A group receiving mexiletine tablets and B group Vitamin C tablets), Blinding description: This research is a double-blind clinical trial (in order to make this study double-blind, the drugs used for the patients at the beginning of the study are A/B by the supervisor of the surgery department so that the clinical caregiver and the participants do not know the type of drug received. 2 Pain after abdominal surgery. Intervention 1: One group received 600 mg mexilten tablets orally. The drug was administered two hours before the operation along with 50 cc of water. After the patients entered the operating room, the patients were under general anesthesia with the same drugs (propofol 2 mg per kg of patient weight or Nesdonal 5 mg per kg The patient's weight, midazolam 0.01 mg per kilogram of the patient's weight, fentanyl 2-3 macros per kilogram of the patient's weight and atrocurium 0.5 mg per kilogram of the patient's weight for induction and for maintenance of isoflurane 1-2% and oxygen N2o (50 50/) was used. For patients during surgery, 1 macro per kilogram of the patient's weight of fentanyl was repeated every hour, and then at the end of the surgery, a reverse muscle relaxant was performed with a mixture of neostigmine and atropine. Then after the surgery and in At 6, 12, 24 hours after the operation, the pain level of the patients was checked based on the VAS model, and in case of VAS>5, pethidine 30-50mg was injected intravenously to the patients, and at the end of the first day, the amount of narcotic used was recorded in the questionnaire by a nurse who had previously It was trained and registered. Intervention 2: One group received vitamin C tablets orally. The drug was administered two hours before the operation along with 50 cc of water. After patients enter the operating room, patients under general anesthesia with the same drugs (propofol 2 mg per kg of patient weight or Nesdonal 5 mg per kg of patient weight, midazolam 0.01 mg per kg of patient weight, fentanyl 2 - 3 macros per kilogram of patient weight and atrocurium 0.5 mg per kilogram of patient weight for induction and for maintenance, 1-2% isoflurane and oxygen N2o (50/50) were used. For patients during surgery, 1 macro per Every kilogram of the patient's weight, fentanyl was repeated every hour, and then at the end of the surgery, the reverse muscle relaxant was performed by a mixture of neostigmine and atropine. Then, after the surgery and at 6, 12, 24 hours after the operation, the pain level of the patients was measured according to the pattern VAS was checked and in case of VAS>5, pethidine 30-50mg was injected intravenously to the patients and at the end of the first day, the amount of narcotic used was recorded in the questionnaire by a trained nurse. Yes - There is a plan to make this available What will be shared: Part of the data, such as the information related to the main outcome, can be shared When: The access period starts 6 months after the results are published To whom: It is accessible to all researchers Conditions: All analysis and use of documentation is permitted Where to obtain: The person responsible for the scientific responsibility of the study How to obtain: Contact the person responsible for the scientific accountability of the study Comments:
public Abolfazl Jadidi davoudabadi
Resalat Square, Niroye daryaei Street, Hossein Ali Street
Tehran Iran (Islamic Republic of) 1676855733 +98 21 7719 0836 Abolfazl.jadidi2016@gmail.com Islamic Azad University scientific Abolfazl Jadidi davoud abadi
Resalat Square, Niroye daryaei Street, Hossein Ali Street
Tehran Iran (Islamic Republic of) 1676855733 +98 21 7719 0836 Abolfazl.jadidi2016@gmail.com Islamic Azad University Iran (Islamic Republic of) Informed and written consent Elective surgery Age 15-75 Absence of drug and alcohol abuse 15 years 75 years Both Loss of consciousness Hemodynamic disorder Abnormal intraoperative bleeding The duration of the operation is more than 4 hours T81.9 Unspecified complication of procedure Treatment - Drugs Placebo One group received 600 mg mexilten tablets orally. The drug was administered two hours before the operation along with 50 cc of water. After the patients entered the operating room, the patients were under general anesthesia with the same drugs (propofol 2 mg per kg of patient weight or Nesdonal 5 mg per kg The patient's weight, midazolam 0.01 mg per kilogram of the patient's weight, fentanyl 2-3 macros per kilogram of the patient's weight and atrocurium 0.5 mg per kilogram of the patient's weight for induction and for maintenance of isoflurane 1-2% and oxygen N2o (50 50/) was used. For patients during surgery, 1 macro per kilogram of the patient's weight of fentanyl was repeated every hour, and then at the end of the surgery, a reverse muscle relaxant was performed with a mixture of neostigmine and atropine. Then after the surgery and in At 6, 12, 24 hours after the operation, the pain level of the patients was checked based on the VAS model, and in case of VAS>5, pethidine 30-50mg was injected intravenously to the patients, and at the end of the first day, the amount of narcotic used was recorded in the questionnaire by a nurse who had previously It was trained and registered. One group received vitamin C tablets orally. The drug was administered two hours before the operation along with 50 cc of water. After patients enter the operating room, patients under general anesthesia with the same drugs (propofol 2 mg per kg of patient weight or Nesdonal 5 mg per kg of patient weight, midazolam 0.01 mg per kg of patient weight, fentanyl 2 - 3 macros per kilogram of patient weight and atrocurium 0.5 mg per kilogram of patient weight for induction and for maintenance, 1-2% isoflurane and oxygen N2o (50/50) were used. For patients during surgery, 1 macro per Every kilogram of the patient's weight, fentanyl was repeated every hour, and then at the end of the surgery, the reverse muscle relaxant was performed by a mixture of neostigmine and atropine. Then, after the surgery and at 6, 12, 24 hours after the operation, the pain level of the patients was measured according to the pattern VAS was checked and in case of VAS>5, pethidine 30-50mg was injected intravenously to the patients and at the end of the first day, the amount of narcotic used was recorded in the questionnaire by a trained nurse. Pain. Timepoint: In recovery and at 6, 12, 24 hours after the operation, the amount. Method of measurement: Visual Analogue Scale. The amount of narcotic (pethidine) received after the operation. Timepoint: after surgery. Method of measurement: amount of drug used. Islamic Azad University Approved 2022-08-15 Ethics Committee of ‏Tehran Islamic Azad University of Medical Sciences Tehran, Doktor Shariati St., Golhak Do Rahi, Amir Pabarja St., Aine Blvd., Corner of Gol Yakh St., Headquarters Building of Tehran Islamic Azad University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)