]>
IRCT20200406046966N1 IRCT 2020-04-18 Esfahan University of Medical Sciences Effect of Dexmedetomidine on patient's sedation and surgeon's satisfaction during wisdom tooth surgery Evaluation of patient's sedation and surgeon's satisfaction by applying the combination of Dexmedetomidine and Lidocaine during wisdom tooth surgery 2020-04-08 anticipated 26 Complete https://irct.ir/trial/47009 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization steps are as followed: for the first patient, two envelopes with the same appearance are selected, inside one of them there is a card on which dexmedetomidine in combination with lidocaine is written, and inside the other is a card on which lidocaine alone is written. Before the surgery, surgeon randomly selects one of the envelopes and only the researcher knows the content of envelope and the type of anesthesia isn't told to the surgeon prior to the start of injection and finishing the surgical procedure. After that, the surgeries are performed alternately. (Note that if for the first patient, surgery is performed by the combination of dexmedetomidine and lidocaine; for the opposite tooth surgery, lidocaine alone will be used and vice versa.), Blinding description: In this study, both participants and surgeon aren't aware of the type of anesthetic medications (in the other words, surgeon doesn't know for which patient uses the combination of dexmedetomidine and lidocaine or lidocaine alone) and only the researcher is aware of the cartridge combination. So, this study is double blinded. 3 Mandibular impacted wisdom tooth. Intervention 1: Intervention group: In the intervention group, the patient undergoes local anesthesia with 10µg dexmedetomidine in combination with lidocaine 2% with epinephrine 1/80000. Cartridges are from Eksir brand. Each vial of Dexmedetomidine contains 2 ml (200µg) of the drug. /1 cc of each vial contains 10 µg of drug which is added to the cartridge of the intervention group with insulin syringe. Cartridges containing dexamedetomidine and lidocaine are similar to cartridges of lidocaine in terms of transparency. Intervention 2: Control group: The control group undergoes local anesthesia with lidocaine 2% with epinephrine 1/80000. Cartridges are from Eksir brand. To equalize the volume and appearance of the cartridges, /1 cc of normal saline is added to the cartridge of control group. Cartridges containing dexamedetomidine and lidocaine are similar to cartridges of lidocaine in terms of transparency. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are unrecognizable. When: 6 months after the publication of the article To whom: Researchers working in academic institutions Conditions: Use of data under the supervision and agreement of the Isfahan University of Medical Sciences vice chancellor of Research and Technology and the project implementer and to achieve the intended aims in the proposal and developing review studies Where to obtain: Dr.Milad Etemadi: etemadi@dnt.mui.ac.ir How to obtain: 1-Contact the project implementer via Email and make a written request for the consent to deliver the data 2-Seeking contact information of Isfahan University of Medical Sciences Vice Chancellor of research and Technology 3-Make a written request to obtain permission from Isfahan University of Medical Sciences Vice Chancellor of research and Technology 4-The data can be accessed only in person from the Department of Oral and Maxillofacial Surgery of Isfahan Dental School. If there is no problem, data will be accessible in 2 weeks. Comments:
public Dr.Milad Etemadi
Department of Oral and Maxillofacial Surgery, School of Dentistry, Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5581 etemadi@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Dr.Milad Etemadi
Oral and Maxillofacial surgery department, School of Dentistry, Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5581 etemadi@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) According to the ASA physical status classification system, patient should be ASA I or ASA II (normal healthy patient or patient with mild systemic disease). Patient with informed consent. Patient's age should be between 18-30 years. Patients should have two wisdom teeth (classified in the same class by Pell & Gregory; mesioangular impaction, level B, class 1 or 2), which are similar in terms of surgical severity; No general contraindications (in these patients use of dexmedetomidine is contraindicated: patients with low blood pressure, bradycardia, sinus disorder, unstable high blood pressure, arousability, tachyphylaxis and liver disorders.) No lesions and malignancies at the surgical site; No smoking. 18 years 30 years Both Patient with wisdom tooth surgery on one side; Occurring medical problems during surgery; Patient who needs more than one cartridge injection; Surgery lasting more than 20 minutes. K01.1 Impacted teeth Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, the patient undergoes local anesthesia with 10µg dexmedetomidine in combination with lidocaine 2% with epinephrine 1/80000. Cartridges are from Eksir brand. Each vial of Dexmedetomidine contains 2 ml (200µg) of the drug. /1 cc of each vial contains 10 µg of drug which is added to the cartridge of the intervention group with insulin syringe. Cartridges containing dexamedetomidine and lidocaine are similar to cartridges of lidocaine in terms of transparency. Control group: The control group undergoes local anesthesia with lidocaine 2% with epinephrine 1/80000. Cartridges are from Eksir brand. To equalize the volume and appearance of the cartridges, /1 cc of normal saline is added to the cartridge of control group. Cartridges containing dexamedetomidine and lidocaine are similar to cartridges of lidocaine in terms of transparency. The patient's sedation rate. Timepoint: After the intervention. Method of measurement: Short Dental Fear Questionnaire. Surgeon's satisfaction. Timepoint: After the intervention. Method of measurement: Visual Analogue Scale. Patient's cooperation level. Timepoint: After the intervention. Method of measurement: Data collection form. Evaluation of patient's satisfaction. Timepoint: After the intervention. Method of measurement: Visual Analogue Scale. Esfahan University of Medical Sciences Approved 2020-04-04 Ethics committee of Isfahan University of Medical Sciences Hezar jarib St., Isfahan university of medical sciences Isfahan Isfehan Iran (Islamic Republic of)