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IRCT20220814055685N1 IRCT 2022-12-10 Ghoum University of Medical Sciences Effect of intra coronary morphine in STEMI Study of the effect of Intra-coronary morphine vs placebo in the treatment of acute ST-segment elevation myocardial infarction 2022-12-22 anticipated 110 Complete https://irct.ir/trial/65945 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into two groups using the randomized balanced block method with block sizes of 4 and 6. The random sequence is generated by an epidemiologist by running an online program on the website (https://www.sealedenvelope.com), Blinding description: In this study, the clinical caregiver, and outcome assessor were blinded to the group allocation. In order to hide the concealment from random allocation, we use the method used to implement a random sequence on the participants in the study, such that before the allocation of the individual, the assigned group does not specify. by using non - transparent sealed envelopes with a random sequence in ( Sequentially numbered, sealed, opaque envelopes ) In this method each of the random created on a card is placed in the mail packet, respectively .in order to maintain a random sequence, it is performed on the outer surface of .finally, the envelope of the envelope packets is glued inside the box .at the beginning of registration of the participants, according to the order of eligible participants to study, one of the mail envelopes is unfolded, and the assigned group of the participants is revealed. 3 Acute myocardial infarction with ST elevation. Intervention 1: Intervention group: One dose of morphine sulfate hydrochloride with a dose of 5 mg with a single administration slowly over a period of one to two minutes at the beginning of primary PCI inside the coronary arteries. Intervention 2: Control group: Patients undergoing PPCI receive 3 cc of normal saline intracoronary after receiving routine treatment. Yes - There is a plan to make this available What will be shared: All data can be shared after people have not been identified When: Start the access period 6 months after printing the results To whom: Researchers working in academic and scientific institutions Conditions: Use of meta-analysis Where to obtain: To the responsible author whose details were given and it is also clear in the relevant articles. How to obtain: Correspondence with the responsible author Comments:
public Seyed Fakhreddin Hejazi
Shahid Beheshti Blv
Qom Iran (Islamic Republic of) 3719964797 +98 25 3612 2000 sf-hejazi@muq.ac.ir Ghoum University of Medical Sciences scientific Ali Abdollahi
Shahid Beheshti Blv
Qom Iran (Islamic Republic of) 3719964797 +98 25 3612 2000 aliabdollahi11@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Age above 18 years Acute myocardial infarction with STEMI patients 18 years no limit Both Known allergy to morphine hydrochloride Patients with coronary artery bypass grafting Patients with cardiac arrest are resuscitated Mechanical ventilation on arrival Morphine injection in the emergency room Patients with right ventricular stroke Serious failure of liver cells Any cardiac arrythmia I21 ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Treatment - Drugs Placebo Intervention group: One dose of morphine sulfate hydrochloride with a dose of 5 mg with a single administration slowly over a period of one to two minutes at the beginning of primary PCI inside the coronary arteries. Control group: Patients undergoing PPCI receive 3 cc of normal saline intracoronary after receiving routine treatment. Coronary reperfusion. Timepoint: One and Six Day after the intervention. Method of measurement: Trans thoracic echocardiography. Cardiac enzyme(troponin). Timepoint: Every 12 hours during the first 24 hours and then every 12 hours for the next 48 hours. Method of measurement: Blood test. Ghoum University of Medical Sciences Approved 2022-06-12 Research Ethics Committees of Qom University of Medical Sciences Shahid Lavasani St Qom Ghoum Iran (Islamic Republic of)