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IRCT20141009019470N99 IRCT 2020-06-18 Shiraz University of Medical Sciences Title: Effect of Clonidine on Post-operative Nausea and Vomiting in Breast Cancer Surgery Title: Effect of Clonidine on Post-operative Nausea and Vomiting in Breast Cancer Surgery 2020-07-21 anticipated 68 Complete https://irct.ir/trial/44970 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients are divided into two groups of four permutation blocks based on a randomization table from Randomization.com, Blinding description: A nurse in the ward gives patients clonidine or placebo tablets one hour before the patient enters the operating room on a randomized basis. The patient, an individual assessment of the patient in the operating room , recovery room and ward nurses and are unaware of the study groups. 2-3 Breast Cancer. Intervention 1: Intervention group:Patients are given 0.2 mg of clonidine tablets in the morning. Intervention 2: Control group:Control group: Patients are given one tablet in the morning as a placebo. (Made by Shiraz University of Medical Sciences School of Pharmacy), which is similar to clonidine tablets. No - There is not a plan to make this available Justification or reason for not sharing IPD is Its against our policies.
public Shabnam Heidarynezhad
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3674 4270 shab.hn1998@gmail.com Shiraz University of Medical Sciences scientific Ali Akbari
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 akbaria@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients Candidate for Breast Cancer Surgery Ages 15 to 70 years ASA Class I-II General Anesthesia 15 years 70 years Female A history of postoperative nausea and vomiting Patients who have received antiemetic drugs such as ondansetron or dexamethasone 24 hours before surgery History of motion sickness Allergy to Propofol and Clonidine Concomitant use of beta-blocker medication that may affect a patient's heart rate Systolic blood pressure less than 100 History of using Steroid History of myocardial infarction History of tricyclic antidepressant use History of kidney dysfunction D05.10 Intraductal carcinoma in situ of unspecified breast Prevention Placebo Intervention group:Patients are given 0.2 mg of clonidine tablets in the morning. Control group:Control group: Patients are given one tablet in the morning as a placebo. (Made by Shiraz University of Medical Sciences School of Pharmacy), which is similar to clonidine tablets. Post-operative Nausea and Vomiting. Timepoint: Postoperative nausea and vomiting in recovery is recorded at 0-15-30 and 45 minutes. After transferring the patient to the surgical ward, the incidence of postoperative nausea and vomiting is evaluated at 6 and 24 hours. Method of measurement: Likert. Hemodynamic changes. Timepoint: Blood pressure and heart rate are recorded in the surgical ward in the operating room before induction after induction and in recovery at 0-15-30 and 45 minutes.After transferring the patient to the surgical ward, the patient's blood pressure is checked at 24,2,4,6,12 hours. Method of measurement: Monitoring. Shiraz University of Medical Sciences Approved 2020-03-01 Ethics committee of Shiraz University of Medical Sciences Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)