Protocol summary
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Study aim
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Comparison of the effect of low-dose intravenous ketamine with haloperidol in reducing delirium and agitation in elderly patients admitted to the intensive care unit: a randomized clinical trial
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Design
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Non-blind clinical trial on 44 elderly patients admitted to the intensive care unit of hospitals affiliated to Tehran University of Medical Sciences
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Settings and conduct
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First, individuals were selected using simple randomization and then eligible individuals were selected by random blocking method with a ratio of 1: 1 to two groups, including: groups receiving haloperidol 2.5 mg intramuscularly and receiving ketamine at a dose of 20 mg. Intravenously). At 5, 10, 15 times, the information was completed. In 60 minutes, a checklist of side effects and physician satisfaction is completed.
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Participants/Inclusion and exclusion criteria
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Age over 65 years and hospitalization in the intensive care unit; Richmond Agitation Sedation Score more equal to 2; not positive troponin and BNP; systolic pressure less than 140 mm Hg; diastolic pressure less than 95; heart rate less than 100
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Intervention groups
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Group A (receiving ketamine at a dose of 20 mg Intravenously) and group B (receiving haloperidol 2.5 mg intramuscularly)
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Main outcome variables
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Reynolds and Richmond Score
General information
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Reason for update
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Changing the blinding process
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230522058252N1
Registration date:
2023-05-27, 1402/03/06
Registration timing:
retrospective
Last update:
2023-07-16, 1402/04/25
Update count:
1
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Registration date
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2023-05-27, 1402/03/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-03-05, 1399/12/15
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Expected recruitment end date
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2022-03-06, 1400/12/15
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Actual recruitment start date
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2021-03-05, 1399/12/15
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Actual recruitment end date
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2022-03-06, 1400/12/15
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Trial completion date
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2022-03-21, 1401/01/01
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Scientific title
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Comparison of the effect of low-dose intravenous ketamine with haloperidol in reducing delirium and agitation in elderly patients admitted to the intensive care unit: an open-label randomized clinical trial
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Public title
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Low-dose intravenous ketamine with haloperidol in reducing delirium and agitation
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age over 65 years and hospitalization in the intensive care unit
Richmond Agitation Sedation Score more equal to 2
Troponin and BNP not positive
Systolic pressure less than 140 mm Hg
Diastolic pressure less than 95
Heart rate less than 100
Exclusion criteria:
Dissatisfaction of the patient or the patient's guardian
Cardiovascular disease
History of psychosis
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Age
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From 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
44
Actual sample size reached:
44
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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First, individuals were selected using simple randomization and then eligible individuals were selected by random blocking method with a ratio of 1: 1 to two groups. Randomization was performed using random number tables, and
the results were assessed by a doctor who was blinded to the study protocol.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-03-03, 1399/12/13
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Ethics committee reference number
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IR.TUMS.IKHC.REC.1399.548
Health conditions studied
1
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Description of health condition studied
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Delirium in elderly patients
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ICD-10 code
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F05
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ICD-10 code description
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Delirium, not induced by alcohol and other psychoactive substances
2
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Description of health condition studied
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Agitation in elderly patients
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ICD-10 code
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R45.1
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ICD-10 code description
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Restlessness and agitation
Primary outcomes
1
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Description
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Reynolds and Richmond score less than one
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Timepoint
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At the beginning of the study (before the injection) and again at 5, 10, 15 minutes after the injection
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Method of measurement
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Reynolds and Richmond Score
Secondary outcomes
1
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Description
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The duration of reaching a Reynolds and Richmond score less than one
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Timepoint
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At the beginning of the study (before the injection) and again at 5, 10, 15 minutes after the injection
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Method of measurement
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Reynolds and Richmond Score
2
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Description
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Side effects
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Timepoint
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60 minutes after the start of the intervention
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Method of measurement
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ECG to evaluate QT interval, blood pressure, heart rate, presence of seizures or hallucinations before and after receiving any of the drugs.
Intervention groups
1
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Description
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Intervention group 1: receiving haloperidol 2.5 mg intramuscularly
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: receiving ketamine at a dose of 20 mg
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available