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IRCT20181112041616N2 IRCT 2023-08-28 Jeeroft University of Medical Sciences The effect of dexamethasone on antiemetics The effect of dexamethasone on antiemetic use after pelvic and femoral surgery in patients 2023-09-23 anticipated 140 Complete https://irct.ir/trial/72276 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: A code of 1 to 140 is considered for each questionnaire. And the random assignment is that we consider two groups named A and B, after that we put even numbers in group A and odd numbers in group B, and finally one group is called intervention and the other group. We consider it as control, Blinding description: Participants, principal investigator, physicians, nurses, orthopedic surgeons, data collection and outcome assessors, and the data safety and monitoring committee. 3 Hip and femur surgery. Intervention group: Before the operation, patients in both groups will receive a single oral dose of acetaminophen 1000 mg and pregabalin 100 mg. In the intervention group, patients will receive 10 mg of dexamethasone intravenously in 90 minutes after surgery. A local infiltration cocktail of 62 ml was injected during the operation, which consists of the following drugs: Also, in both groups, all patients during the first 24 hours after the operation, (3 mg/kg and the maximum dose of 300 mg, 60 ml) 0.5% ropivacaine , will receive 30 mg (1 ml) of ketorolac and 5 mac/kg of epinephrine. Analgesics: acetaminophen 1000 mg orally every 8 hours, oxycodone 5 mg orally every 12 hours as needed for moderate pain or 10 mg for severe pain, meloxicam 7.5 mg orally every 12 hours, gabapentin 100 mg orally every 12 hours 12 hours and diazepam 5 mg orally as needed for muscle spasms. In addition, patients in both groups will receive more opioid analgesics as needed. If necessary, intravenous doses of four milligrams of ondansetron will be prescribed every 4-6 hours to control post-operative nausea and vomiting (PONV). Prochloroprazine will be used as a secondary antiemetic. Complications such as readmission, infection, reoperation, dislocation, venous thrombosis, pulmonary embolism, pneumonia and other post-operative cases are also investigated.To collect medical records information: age, sex, body mass index, type of surgery, smoking status, diabetes status and measurement of glycosylated hemoglobin less than 3 months before surgery will be used.. 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 further information".
public دکتر سینا حیدری
Shahid Square - Imam Khomeini Hospital
Jiroft Iran (Islamic Republic of) 7861634200 +98 34 4331 7302 ehsanmovahed89@yahoo.com Jeeroft University of Medical Sciences scientific Yasin Sohrani
Shahid Square - Imam Khomeini Hospital
Jiroft Iran (Islamic Republic of) 7861634200 +98 34 4331 7302 ehsanmovahed89@yahoo.com Jeeroft University of Medical Sciences Iran (Islamic Republic of) All patients over 18 years old in 2022 who undergo hip and femur surgery 18 years no limit Both Patients who are undergoing surgery or have a recent history of pregnancy, use steroid or immunosuppressant drugs within 6 months after kidney or liver surgery, and have drug and alcohol abuse. M95-M99 Other acquired deformities of musculoskeletal system and connective tissue Treatment - Drugs Intervention group: Before the operation, patients in both groups will receive a single oral dose of acetaminophen 1000 mg and pregabalin 100 mg. In the intervention group, patients will receive 10 mg of dexamethasone intravenously in 90 minutes after surgery. A local infiltration cocktail of 62 ml was injected during the operation, which consists of the following drugs: Also, in both groups, all patients during the first 24 hours after the operation, (3 mg/kg and the maximum dose of 300 mg, 60 ml) 0.5% ropivacaine , will receive 30 mg (1 ml) of ketorolac and 5 mac/kg of epinephrine. Analgesics: acetaminophen 1000 mg orally every 8 hours, oxycodone 5 mg orally every 12 hours as needed for moderate pain or 10 mg for severe pain, meloxicam 7.5 mg orally every 12 hours, gabapentin 100 mg orally every 12 hours 12 hours and diazepam 5 mg orally as needed for muscle spasms. In addition, patients in both groups will receive more opioid analgesics as needed. If necessary, intravenous doses of four milligrams of ondansetron will be prescribed every 4-6 hours to control post-operative nausea and vomiting (PONV). Prochloroprazine will be used as a secondary antiemetic. Complications such as readmission, infection, reoperation, dislocation, venous thrombosis, pulmonary embolism, pneumonia and other post-operative cases are also investigated.To collect medical records information: age, sex, body mass index, type of surgery, smoking status, diabetes status and measurement of glycosylated hemoglobin less than 3 months before surgery will be used. Pain score scale, use of antiemetic drug after surgery. Timepoint: Oxycodone 5 mg orally every 12 hours for moderate pain and 4 mg of ondansetron postoperatively every 4-6 hours to control nausea and vomiting. Method of measurement: Oxycodone 5 mg orally every 12 hours for moderate pain and 4 mg of ondansetron postoperatively every 4-6 hours to control nausea and vomiting. Jeeroft University of Medical Sciences Approved 2023-08-27 کمیته اخلاق دانشگاه علوم پزشکی جیرفت Shahid Square - Jiroft University of Medical Sciences Jiroft Kerman Iran (Islamic Republic of)