Computational protocol: Hemodynamic changes following injection of local anesthetics with different concentrations of epinephrine during simple tooth extraction: A prospective randomized clinical trial

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Protocol publication

[…] This prospective randomized clinical trial was carried out from October 1, 2014 to January 1, 2015 in the Colleges’ Dental Hospital. One hundred-twenty patients who had single simple tooth extraction were included in the study. Dental extractions were performed by qualified dental interns under close supervision of surgery instructors. Sample size was estimated depending on a power calculation. At level of significance α = 0.05 with estimated standard deviation 1.2 and power 0.9, the sample size from each group should be at least 38.Inclusion criteria: patients who weren’t diagnosed as hypertensive and their blood pressure <140/90 mm Hg. Exclusion criteria: hypertension, cardiovascular disease, sickle cell anemia, congenital methemoglobinemia, hyperthyroidism, pregnancy, breastfeeding, allergy to local anesthetics, any contraindications to epinephrine, and if the extraction required more than 2 local anesthetic cartridges or the duration exceeded 30 minutes.The study followed the World Medical Association Declaration of Helsinki and was registered in the Colleges Research Center (USRP/2013/159). Study aims and procedures were explained to the included patients before signing the informed consents. Patients’ information was documented in questionnaire papers about the name, age, gender, mobile number, file number.Patients were divided randomly into three parallel groups; each of them contained 40 patients. One hundred-twenty questionnaires contained three groups were mixed. Each group had 40 questionnaires presented a study group and its number was written (1, 2 and 3). Random distribution was achieved by asking the patient to choose one questionnaire and the type of local anesthetic was selected accordingly. Group 1: received 2 cartridges of lidociane 2% with epinephrine 1:80,000 (L 80). Group 2: received 2 cartridges of articaine 4% with epinephrine 1:100,000 (A 100). Group 3: receive 2 cartridges of articaine 4% with epinephrine 1:200,000 (A 200).All procedures in the study were performed in morning sessions with relaxed atmosphere and no preoperative anxiolytic medications were prescribed. On the dental chair, a pulse oximeter (Merlin medical® Pulse Oximeter) was applied to the left index finger of the patient then heart rate and oxygen saturation were recorded. Blood pressure was measured by an electronic sphygmomanometer (OMRON® Automatic Blood Pressure Monitor). Three minutes later, aspiration was done followed by injection of 2 cartridges (each of 1.8 ml) of local anesthesia selected according to the group. If blood was encountered in the syringe, the clinician had to withdraw the needle, replace the cartridge, and repeat the aspiration then do the injection. Three minutes after anesthesia; blood pressure, oxygen saturation, and heart rate were measured again. The last measurements were taken three minutes after extraction for the same hemodynamic parameters. The differences of the four parameters between the 1st time point and the 2nd time point were calculated and compared among the three groups. Similar calculation was done for the difference between the 1st and 3rd time point. Data analyses were performed by statistical software SPSS version 22.0 for Windows. […]

Pipeline specifications

Software tools merlin, SPSS
Application Miscellaneous
Organisms Homo sapiens
Diseases Cardiovascular Diseases, Hypersensitivity, Hypertension, Hyperthyroidism, Drug-Related Side Effects and Adverse Reactions
Chemicals Carticaine, Epinephrine, Lidocaine, Oxygen