Protocol summary

Study aim
Comparison of the effect of Haloperidol and Dexmedetomidine on delirium and agitation in patients under mechanical ventilation following concussion admitted to the ICU
Design
In this double-blind clinical trial study, 60 mechanically ventilated patients in the intensive care unit were randomly divided into intervention groups 1 and 2.
Settings and conduct
In this study, 60 patients under mechanical ventilation admitted to the ICU of Imam Khomeini Hospital in Ahvaz were selected by convenience sampling and randomly divided into two intervention groups 1 and 2. Patients in intervention group 1, in addition to routine care for 7 days, 2.5 mg of haloperidol in bolus and then 0.5 - 2 mg/h and patients in group 2, 1μg/kg of bolus dexmedetomidine and then 0.2-0.7 μg in Kg/h was injected by infusion. In order to blind in this study, the patient caregiver and statistical analyzer were unaware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: Patients 18-65 years old with traumatic brain injury APACHE II criteria more than 48, RASS criteria between +1 to +4, At least 48 hours after ICU admission. Exclusion criteria include: 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, arkinson's, hypotension, bradycardia), Kidney or liver dysfunction
Intervention groups
In addition to routine care, for 7 days, 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. Micrograms per kilogram per hour will be infused with dexmedetomidine.
Main outcome variables
Delirium level, agitation rate, length of hospital stay, duration of mechanical ventilation and need for sedation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200803048288N1
Registration date: 2020-09-01, 1399/06/11
Registration timing: retrospective

Last update: 2020-09-01, 1399/06/11
Update count: 0
Registration date
2020-09-01, 1399/06/11
Registrant information
Name
Roya Darkhorد
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3377 7966
Email address
darkhor.r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-22, 1398/02/02
Expected recruitment end date
2020-03-02, 1398/12/12
Actual recruitment start date
2019-04-25, 1398/02/05
Actual recruitment end date
2020-03-15, 1398/12/25
Trial completion date
2020-03-18, 1398/12/28
Scientific title
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
Public title
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
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
APACHE II criteria more than 48 RASS criteria between +1 to +4 At least 48 hours after hospitalization in the intensive care unit
Exclusion criteria:
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357157941
Approval date
2020-05-09, 1399/02/20
Ethics committee reference number
IR.AJUMS.REC.1399.155

Health conditions studied

1

Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition

Primary outcomes

1

Description
Delirium
Timepoint
Every 6 hours a day for 7 days
Method of measurement
APACHE II criteria

2

Description
Agitation
Timepoint
Every 6 hours a day for 7 days
Method of measurement
APACHE II criteria

Secondary outcomes

1

Description
Duration of hospital stay
Timepoint
Daily
Method of measurement
Total days of hospitalization after receiving the intervention

Intervention groups

1

Description
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.
Category
Prevention

2

Description
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.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Roya Darkhor
Street address
Imam Khomeini Hospital, Shahid Ahvazian St., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Darkhor.r@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Vice Chancellor For Research of Ahvaz Jundishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Darkhor.r@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Roya Darkhor
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Darkhor.r@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Roya Darkhor
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Darkhor.r@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Roya Darkhor
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Darkhor.r@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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