Evaluation of administration of Dexmedetomidine on recovery conditions in mentally-disabled adults, candidate for dental treatment under general aneasthesia

evaluating the effect of dexmedetomidine on recovery conditions in mentally-disabled adults undergoing dental treatment with general anesthesia

This study is a randomized clinical trial, single blinded.

This is a single-blinded controlled clinical trial (assigning the first patient to the control or intervention group randomly and then the other patients are placed in a different group from the previous patient, respectively). This study will be carried out in Dental Hospital of Isfahan University of Medical Sciences. After anesthesia induction, patients in intervention group will receive 2 mcg/kg/hr Dexmedetomidine until the end of anesthesia. While under anesthesia, vital signs such as heart rate and blood pressure will be evaluated every 15 minutes. Anesthesia time will be recorded as the interval between administrating and terminating anesthetics. Recovery time will be recorded as the interval between end of dental treatment and discharging the patient. Data collector, researcher and patients will be blinded.

inclusion criteia: mentally-disabled patients without systemic or physical disorders who need to undergo dental treatment under general anesthesia age range: 10-50 Patients unwilling to participate in the study or using tranquillizers, anticonvulsive, antidepressants, antipsychotic drugs or those allergic to soy or eggs, suffering from hepatic diseases or morbidly obese (BMI≥40) will not be included.

intervention group: Dexmedetomidine control group: Propofol

systolic blood pressure; heart rate; anesthesia time; needing analgesia in recovery; unrest in recovery; recovery time

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.

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.

Data concerning main outcomes will be shared.

6 months after publication

Data will be available for academic researchers.

in order to perform further analysis

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.

A written request containing related information and affiliation(s) with the reason why these data are needed should be submitted.