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IRCT20200803048288N1 IRCT 2020-09-01 Ahvaz University of Medical Sciences Comparative study of the effect of haloperidol and dexmedetomidine on Restlessness in mechanically ventilated patients following concussion admitted to the intensive care unit of Imam Khomeini Hospital Comparative study of the effect of Haloperidol and Dexmedetomidine on delirium and agitation in mechanically ventilated patients following concussion admitted to the intensive care unit 2019-04-22 anticipated 60 Complete https://irct.ir/trial/50440 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients were selected by convenience sampling and divided into two intervention groups 1 (Haloprodil recipient) and intervention 2 (Dexmedtomidin recipient) through a random number table with even numbers assigned to intervention group 1 and odd numbers for intervention group 2. In this way, the first even number was assigned to the first patient of intervention group 1 and the first odd number to intervention group 2, and the even and selected numbers were selected and grouped from the table of random numbers of patients, respectively, Blinding description: In this study, the nurse and patient caregiver did not know which group of patients the intervention group was in and whether the researcher was receiving Haloperidol or Dexmedetomidine in the ward, and the statistical analyzer was also unaware of the type of groups. 3 Delirium. Intervention 1: Intervention group 1: In addition to routine care, patients in the first group will be injected with 2.5 mg of haloperidol as a bolus and then 2.5-5 mg / h as an infusion of haloperidol. Intervention 2: Intervention group2: In addition to routine care, patients in the second group will be injected with 1 μg / kg dexmedetomidine as a bolus and then 0.2-0.7 μg / kg as an infusion of dexmedetomidine. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is En There is no more information.
public Roya Darkhor
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8383 Darkhor.r@ajums.ac.ir Ahvaz University of Medical Sciences scientific Roya Darkhor
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8383 Darkhor.r@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) APACHE II criteria more than 48 RASS criteria between +1 to +4 At least 48 hours after hospitalization in the intensive care unit 18 years 65 years Both Dissatisfaction of the patient's legal guardian Patients who are candidates for surgery Unstable hemodynamic status History of mental illness or use of neuroleptics History of drug use any contraindications to Dexmedetomidine or Haloperidol (Allergy, Parkinson's, Hypotension, BradyCardiac) Renal or Hepatic Fysfunction F05 Delirium due to known physiological condition Prevention Prevention Intervention group 1: In addition to routine care, patients in the first group will be injected with 2.5 mg of haloperidol as a bolus and then 2.5-5 mg / h as an infusion of haloperidol. Intervention group2: In addition to routine care, patients in the second group will be injected with 1 μg / kg dexmedetomidine as a bolus and then 0.2-0.7 μg / kg as an infusion of dexmedetomidine. Delirium. Timepoint: Every 6 hours a day for 7 days. Method of measurement: APACHE II criteria. Agitation. Timepoint: Every 6 hours a day for 7 days. Method of measurement: APACHE II criteria. Duration of hospital stay. Timepoint: Daily. Method of measurement: Total days of hospitalization after receiving the intervention. Ahvaz University of Medical Sciences Approved 2020-05-09 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)