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IRCT20240703062318N1 IRCT 2024-08-22 Gorgan University of Medical Sciences Investigating the effectiveness of injection of lidocaine and articaine anesthesia on heart rate, blood oxygen saturation percentage and blood pressure Comparison of anesthetic injection lidocaine with articaine on changes in heart rate ,blood oxygen saturation percentage and blood pressure in Candidate patients for tooth extraction: a Randomized clinical trial 2024-09-22 anticipated 44 Complete https://irct.ir/trial/77710 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: Block allocation method: People are randomly assigned to articaine (A) and lidocaine (B) groups. Random block method will be used to assign people to groups. For this purpose, all six positions of letters A and B are considered in blocks of four as in the table below. AABB (1) ABAB (3) ABBA (5) BBAA (2) BABA(4) BAAB(6). 11 blocks of 4 are needed to allocate 22 samples in each group (44 people in total). To select 11 blocks first,11 random numbers between 1 and 6 will be generated by repetition (with placement). In this way, a sequence of letters A and B including 44 letters (22 letters A and 22 letters B) will be created, Blinding description: In this double-blind clinical trial study, all injections will be performed by a trained student (researcher) under the supervision of a maxillofacial surgeon (clinician), and the student will be aware of what kind of anesthetic to use for each patient will inject the anesthetic in opaque syringes to the patients and the patient will not know the type of anesthetic injected. Also, the person (nurse) who will measure the desired values ​​(HR, SPO2 and BP) before and after the injection will not know what kind of anesthetic the patient has received. 4 Condition 1: Blood pressure. Condition 2: heartbeat. Condition 3: Blood oxygen saturation percentage. Intervention 1: Intervention group: Patients receiving persocaine-E which contains lidocaine 2% with epinephrine 1/80000 from Darupakhsh company. Each patient will be injected only once and a carpool containing 1.8 ml of the anesthetic substance in one minute by inferior alveolar nerve block method. Intervention 2: Intervention group: Patients receiving Dentacaine 200 which contains articaine 4% with epinephrine 1/200000 from Exir pharmaceutical company. Each patient will be injected only once and one carpool containing 1.8 ml of anesthetic substance in one minute by inferior alveolar nerve block method. . Yes - There is a plan to make this available What will be shared: After de-identifying individuals, the following information is shared: age gender Blood pressure before and after the injection of each anesthetic drug Blood oxygen saturation percentage before and after injection of each anesthetic drug The heart rate before and after the injection of each of the anesthetic drugs When: The access period starts 6 months after the results are published. To whom: Only for researchers working in academic and scientific institutions and students of medical sciences, including medicine, dentistry, pharmacy, etc. Conditions: As a study resource for clinical science research Where to obtain: By email to the responsible author of the article resulting from the study Mr. Seyed Alireza Fazeli Alirezafazeli15@gmail.com How to obtain: If the request is from colleagues and people working in the clinical fields of medical sciences, there will be no process. Comments:
public Seyed Alireza Fazeli
Pardisan dorm complex,17th Daneshjoo Ave,Jahad Town
Gorgan Iran (Islamic Republic of) 4914735780 +98 17 3224 1889 alirezafazelli15@gmail.com Gorgan University of Medical Sciences scientific Rashid Soufizadeh
Factuly of Dentistry,5th Shahriar,Shahriar Town
Gorgan Iran (Islamic Republic of) 4913983632 +98 17 3262 7823 rashidsoufizadeh@gmail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Healthy people between 30 and 50 years old Candidates for extraction of lower jaw teeth 30 years 50 years Both People with cardiovascular, renal, respiratory disease, liver failure and hyperthyroidism pregnant women All diabetic patients People with dental anxiety outside the normal range People who take medications that affect heart rate Treatment - Other Treatment - Other Intervention group: Patients receiving persocaine-E which contains lidocaine 2% with epinephrine 1/80000 from Darupakhsh company. Each patient will be injected only once and a carpool containing 1.8 ml of the anesthetic substance in one minute by inferior alveolar nerve block method. Intervention group: Patients receiving Dentacaine 200 which contains articaine 4% with epinephrine 1/200000 from Exir pharmaceutical company. Each patient will be injected only once and one carpool containing 1.8 ml of anesthetic substance in one minute by inferior alveolar nerve block method. . Number of heartbeats. Timepoint: Before and after injection of anesthesia. Method of measurement: by pulse-oximetry. Blood oxygen saturation. Timepoint: Before and after injection of anesthesia. Method of measurement: by pulse-oximetry. Blood pressure. Timepoint: Before and after injection of anesthesia. Method of measurement: Digital pressure gauge device. Gorgan University of Medical Sciences Approved 2024-08-13 Ethics committee of Golestan University of Medical Sciences Hirkan boulevard , Central Organization of Golestan University of Medical Sciences and Healthcare Services Gorgan Golestan Iran (Islamic Republic of)