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Study aim
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1) Determining and comparing delirium incidence in two groups that receive dexmedetomidine and haloperidol
2) Determining and comparing the severity of delirium incidence in two groups that receive dexmedetomidine and haloperidol
3) Determining the average necessary dose of medicine used in two groups of dexmedetomidine and haloperidol, and comparing them
4) Determining the average time length of prescribing medicine used in two groups of dexmedetomidine and haloperidol, and comparing them
5) Determining and comparing the frequency distribution of medicine side effects in two groups of dexmedetomidine and haloperidol, and comparing them
6) Determining and comparing the average time of patients’ hospitalization in two groups of dexmedetomidine and haloperidol, and comparing them
7) Determining and comparing the average patients’ sedation in two groups of dexmedetomidine and haloperidol, and comparing them
8) Determining and comparing the average time length of intubation and extubation in two groups
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Design
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The patients of this study include all the candidate patients who referred to Shahid Chamran Hospital for coronary artery bypass graft surgery. The volume of sample needed for this study was calculated using the formula of estimating sample volume for prevalence studies. The confidence level was considered 95%, and the agitation prevalence after open surgery of coronary arteries was considered 0.5 due to the lack of similar study which resulted in 44 people in each group. The possibility of collapse in each group was 50 people. Sampling was done as non-probable and random.
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Settings and conduct
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After necessary fixing, the candidate patients for open surgery of coronary arteries were selected by referring the investigator to Shahid Chamran Hospital, and after getting their permission to participate in the study, their demographic information, history of diabetes and blood pressure, addiction to cigarettes and drugs and alcohol, and history of psychiatric drugs’ usage was registered in the questionnaire provided for this purpose and entered in the data gathering form. Also the most recent amount of hemoglobin, WBC, and creatinine of the patients before the surgery were extracted of their medical file and registered. The patients were put into two groups of intervention and control randomly.
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Participants/Inclusion and exclusion criteria
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The entrance criterion: included the 18 to 80 year old; patients who were candidates for open surgery of coronary arteries and referred to Shahid Chamran Hospital; The candidates had agreed to participate in the study; and were free from any psychiatric disease or dementia.
The exit criterion: included lack of candidate’s assistance; shortages in data under study; the patient’s death during the surgery or by entrance to ICU; need to do the surgery again due to bleeding after entrance to ICU; excessive allergy to haloperidol and phenothiazine; Parkinson (trembling at the time of rest) and weakness in CNS; glaucoma; seizure anamnesis; getting anti-seizure; anti-Parkinson، or lithium drugs.
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Intervention groups
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The intervention group were put under dexmedetomidine 1 microgram per kilogram during 10 minutes and preserver infusion of 0.2 to 0.7 Micrograms per hour per kilogram. The control group were put under intramuscular haloperidol 0.5 milligram. In the case of agitation incidence, both groups received treatment dose of haloperidol (0.5 milligram intramuscular).
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Main outcome variables
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The incidence of deliriu، the severity of delirium، the required dosage of medications، the average length of hospitalization، the frequency distribution of drug complications، the mean sedation، the mean duration of intubation and extubation of patients after cardiac surgery in the two groups receiving dexmedetomidine and haloperidol will be different.