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IRCT20190626044013N2 IRCT 2021-04-16 Esfahan University of Medical Sciences Evaluation of Dexmedetomidine effect on mentally-disabled adults, candidate for dental treatment under general aneasthesia Evaluation of administration of Dexmedetomidine on recovery conditions in mentally-disabled adults, candidate for dental treatment under general aneasthesia 2021-04-04 anticipated 50 Complete https://irct.ir/trial/55008 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into two categories of intervention and control. Class randomization: Patients fall into twenty-five standardized classes. There are two people in each class who are similar in age, sex and severity of the disease and are randomly assigned to one of the study groups. The allocation of people in each class is done randomly using envelopes in the package. For this purpose, each time, in two identical envelopes, the names of the participants and in two other identical envelopes, the names of the two study groups will be mentioned. Each envelope of participants will be randomly matched with an envelope of the study groups by lottery method without replacement, and then the envelopes are opened and each person is assigned to the relevant group, Blinding description: Although patients are informed about the study groups in detail prior to intervention, the are unaware of which group they are assigned to during the study. Also, the outcome assessor is only aware of the code assigned to the patient and is not aware of the type of treatment received by him. 2-3 mental disability. Intervention 1: Intervention group:2 mcg/kg/hr dexmedetomidine will be administered via infusion until the end of general anesthesia. Intervention 2: Control group: 50% N2O / 50% O2 along with 100 mcg/kg/min will be administered. Yes - There is a plan to make this available What will be shared: Data concerning main outcomes will be shared. When: 6 months after publication To whom: Data will be available for academic researchers. Conditions: in order to perform further analysis Where to obtain: Requests should either be sent via email to kaviani@dnt.mui.ac.ir, or the person should refer to Dental School of Isfahan University of Medical Sciences. How to obtain: A written request containing related information and affiliation(s) with the reason why these data are needed should be submitted. Comments:
public Dr Naser Kaviani
Dental Hospital, Dental School of Isfahan University of Medical Sciences,Hezarjarib Avenue, Azadi Square,
Isfahan Iran (Islamic Republic of) ۸۱۷۴۶۷۳۴۶۱ +98 31 3792 5558 kaviani@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Dr Naser Kaviani
Dental Hospital, Dental School of Isfahan University of Medical Sciences,Hezarjarib Avenue, Azadi Square,
Isfahan Iran (Islamic Republic of) ۸۱۷۴۶۷۳۴۶۱ +98 31 3792 5558 kaviani@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) mentally disabled without systemic diseases or physical disabilities need dental treatment under general aneasthesia 10 years 50 years Both unwilling to participate in the study using tranquillizers, anticonvulsive, antidepressants, antipsychotic drugs allergic to soy or eggs hepatic diseases Morbidly obese (BMI≥40) F79 Unspecified intellectual disabilities Treatment - Drugs Treatment - Drugs Intervention group:2 mcg/kg/hr dexmedetomidine will be administered via infusion until the end of general anesthesia Control group: 50% N2O / 50% O2 along with 100 mcg/kg/min will be administered. Agitation in recovery. Timepoint: once. Method of measurement: Richmond Scale. Heart rate. Timepoint: Once every 15 minutes during anesthesia. Method of measurement: pulsometer. Anesthesia time. Timepoint: Once during anesthesia. Method of measurement: clock. Analgesia need in recovery. Timepoint: Once during the patient's recovery. Method of measurement: recording. Recovery time. Timepoint: Once during the patient's recovery. Method of measurement: clock. Systolic blood pressure. Timepoint: Once every 15 minutes during anesthesia. Method of measurement: pressure cuff. Esfahan University of Medical Sciences Approved 2020-09-06 Isfahan University of Medical Sciences- Ethics Committee Isfahan University of Medical Sciences, Hezarjarib Avenue, Azadi Square Isfahan Isfehan Iran (Islamic Republic of)