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IRCT20220102053599N1 IRCT 2022-06-25 Iran University of Medical Sciences Comparison of the effect of ketorolac and intravenous lidocaine on fentanyl-induced cough in surgery Comparison of the effect of ketorolac and intravenous lidocaine on fentanyl-induced cough in patients undergoing elective surgery: a Double-blind clinical trial 2022-04-21 anticipated 210 Complete https://irct.ir/trial/61082 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients randomly (using the computer random numbers method which, the numbers 1 to 3 are entered into the computer and by pressing the button to create a random number, a number between 1, 2 and 3 is generated that will indicate the patient group) enter In one of the 3 groups receiving intravenous lidocaine, ketorolac or normal saline are included as placebo until the sample volume is completed, Blinding description: After selecting patients to enter the study, patients are randomly assigned to one of the 3 groups receiving intravenous lidocaine, ketorolac or normal saline as a placebo to complete the sample size. These individuals are in groups A, B, C The group of each patient is written in a sealed envelope and is given to each person in the unit before the operating room by the researcher and the patient enters the operating room with it. The drugs are prepared in similar 5 cc syringes by an anesthetist of the recovery unit who has no role in patient care and the names of the groups are labeled on them. Upon entering the room, the anesthesiologist in the room delivers the medication to the assistant along with the other anesthetics to induce anesthesia. The patient enters the study after obtaining consent and according to the information given about the study, but does not know about the injectable drug. In this way, patients and drug injecting assistants and cough observers (who are responsible for recording data) will be unaware of prescription drugs and study grouping. 3 Fentanyl induced Cough. Intervention 1: Intervention group No.1: The group receiving 1mg / kg intravenous lidocaine 2%(100mg/5ml, Caspian,Tamin,RASHT.IRAN) 3 minutes before intravenous fentanyl ( fentanyl citrate,0.5mg/10ml ,Aburaihan Co.IRAN ). Intervention 2: Intervention group No.2: The group receiving intravenous ketorolac 0.5 mg / kg (Ketorolac-EXIR, 30mg/ml, EXIR.IRAN) 3 minutes before intravenous fentanyl ( fentanyl citrate,0.5mg/10ml ,Aburaihan Co.IRAN ). Intervention 3: Control group: A group receiving the same amount of intravenous saline as the first and second control groups three minutes before intravenous fentanyl. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the publication of the results completely, there is no need to publish the research data separately. Also, in this study, consent is not obtained to use patients' data in other studies, which is another reason that justifies this issue.
public Sara Tahzibi
Unit 1, No. 53, Hojjatdoost St., Naderi St., Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1416635491 +98 21 5528 8568 Sara.tahzibi@gmail.com Iran University of Medical Sciences scientific Nasrin Nouri
Unit 2, No. 618,Next to Saipa Agency, Damavand St. ,
Tehran Iran (Islamic Republic of) 1741633165 +98 21 7741 0544 Nouri.na@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) aged 18 to 60 years, with and with, who any gender ASA 1 or 2 referred to Firoozgar and Hazrat Rasul-e Akram hospitals and are candidates for elective surgery that lasts more than an hour in the period of April 2022 to June 2022 18 years 60 years Both Preoperative pulmonary emphysema Bronchial asthma History of upper respiratory infection during the last 2 weeks Smoking Hypertension Coronary artery disease Has a chronic cough that makes it difficult to diagnose fentanyl-induced cough High pressure inside the eyes, brain or abdomen Taking anti-anxiety and anti-depressant drugs before surgery Taking anti-cough medicines (codeine, dextromethorphan, baclofen, steroids or bronchodilators) during the last week BMI above 28 kg/m2 History of chronic opioid use Taking cough medicines (ACEI & ABR) History of GERD or peptic ulcer History of kidney or liver disease Pregnancy or breastfeeding Known allergy to fentanyl or ketorolac G6PD deficiency disease High risk of GIB Patient reluctance R05 Cough Treatment - Drugs Treatment - Drugs Placebo Intervention group No.1: The group receiving 1mg / kg intravenous lidocaine 2%(100mg/5ml, Caspian,Tamin,RASHT.IRAN) 3 minutes before intravenous fentanyl ( fentanyl citrate,0.5mg/10ml ,Aburaihan Co.IRAN ) Intervention group No.2: The group receiving intravenous ketorolac 0.5 mg / kg (Ketorolac-EXIR, 30mg/ml, EXIR.IRAN) 3 minutes before intravenous fentanyl ( fentanyl citrate,0.5mg/10ml ,Aburaihan Co.IRAN ) Control group: A group receiving the same amount of intravenous saline as the first and second control groups three minutes before intravenous fentanyl. Cough. Timepoint: Within 90 seconds of fentanyl injection. Method of measurement: observation. Cough Intensity. Timepoint: Within 90 seconds of fentanyl injection. Method of measurement: Observation. Cough start time. Timepoint: Within 90 seconds of fentanyl injection. Method of measurement: Stopwatch. Iran University of Medical Sciences Approved 2021-12-07 Ethics committee of Iran University of Medical Sciences Unit 1, No. 53, Hojjatdoost St., Naderi St., Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)