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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Protocol summary
Double-blind clinical trial on 44 elderly patients admitted to the intensive care unit of hospitals affiliated to Tehran University of Medical Sciences
Non-blind clinical trial on 44 elderly patients admitted to the intensive care unit of hospitals affiliated to Tehran University of Medical Sciences
DoubleNon-blind clinical trial on 44 elderly patients admitted to the intensive care unit of hospitals affiliated to Tehran University of Medical Sciences
مطالعه كارآزمايي باليني دو سوكور بر روی 44 بیمار سالخورده ی غیر لوله گذاری شده بستری در بخش مراقبت های ویژه عمومی مجتمع بیمارستانی امام خمینی دانشگاه علوم پزشکی تهران
مطالعه كارآزمايي باليني بدون کورسازی، بر روی 44 بیمار سالخورده ی غیر لوله گذاری شده بستری در بخش مراقبت های ویژه عمومی مجتمع بیمارستانی امام خمینی دانشگاه علوم پزشکی تهران
مطالعه كارآزمايي باليني دو سوكوربدون کورسازی، بر روی 44 بیمار سالخورده ی غیر لوله گذاری شده بستری در بخش مراقبت های ویژه عمومی مجتمع بیمارستانی امام خمینی دانشگاه علوم پزشکی تهران
General information
Double blinded
Not blinded
doublnotbl
1
1
1
1
empty
Changing the blinding process
Changing the blinding process
empty
تغییر روند کورسازی
تغییر روند کورسازی
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
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
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: aan open-label randomized clinical trial
مقایسه تاثیر کتامین دوز پایین وریدی با هالوپریدول در کاهش دلیریوم و آژیتاسیون بیماران سالخورده بستری در بخش مراقبت های ویژه: یک کارآزمایی بالینی تصادفی
مقایسه تاثیر کتامین دوز پایین وریدی با هالوپریدول در کاهش دلیریوم و آژیتاسیون بیماران سالخورده بستری در بخش مراقبت های ویژه: یک کارآزمایی بالینی تصادفی غیر کور
مقایسه تاثیر کتامین دوز پایین وریدی با هالوپریدول در کاهش دلیریوم و آژیتاسیون بیماران سالخورده بستری در بخش مراقبت های ویژه: یک کارآزمایی بالینی تصادفی غیر کور
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.
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.
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.
ابتدا افراد با استفاده از تصادفی سازی ساده انتخاب و سپس افراد حائز شرایط به روش بلوک بندی تصادفی و با نسبت تخصیص1:1 به دو گروه تقسیم میشوند.
ابتدا افراد با استفاده از تصادفی سازی ساده انتخاب و سپس افراد حائز شرایط به روش بلوک بندی تصادفی و با نسبت تخصیص1:1 به دو گروه تقسیم میشوند.تصادفیسازی با استفاده از جداول اعداد تصادفی انجام شده ونتایج توسط دکتری که نسبت به پروتکل مطالعه کور بود، ارزیابی شد.
ابتدا افراد با استفاده از تصادفی سازی ساده انتخاب و سپس افراد حائز شرایط به روش بلوک بندی تصادفی و با نسبت تخصیص1:1 به دو گروه تقسیم میشوندمیشوند.تصادفیسازی با استفاده از جداول اعداد تصادفی انجام شده ونتایج توسط دکتری که نسبت به پروتکل مطالعه کور بود، ارزیابی شد.
Participants and principle investigator are blind
Participants and principle investigator are blind
شرکت کنندگان و محقق اصلی کور نگه داشته شده اند
شرکت کنندگان و محقق اصلی کور نگه داشته شده اند
Recruitment centers
#1
Name of recruitment center - English: Imam Khomeini Hospital Complex
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: khalil pestehei
Full name of responsible person - Persian: خلیل پسته ای
Street address - English: Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
Street address - Persian: استان تهران تهران انتهای بلوار کشاورز
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419733141
Phone: +98 912 608 5696
Fax:
Email: khalilpesteh@yahoo.com
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital Complex
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Khalil Pestehei
Full name of responsible person - Persian: خلیل پسته ای
Street address - English: Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
Street address - Persian: استان تهران تهران انتهای بلوار کشاورز
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419733141
Phone: +98 912 608 5696
Fax:
Email: khalilpesteh@yahoo.com
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital Complex Name of recruitment center - Persian: بیمارستان امام خمینی Full name of responsible person - English: khalil pesteheiKhalil Pestehei Full name of responsible person - Persian: خلیل پسته ای Street address - English: Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran Street address - Persian: استان تهران تهران انتهای بلوار کشاورز City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1419733141 Phone: +98 912 608 5696 Fax: Email: khalilpesteh@yahoo.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: akbar fotouhi
Full name of responsible person - Persian: اكبر فتوحي
Street address - English: Keshavarz Blvd., corner of Quds St., Central Organization of the University, 6th floor
Street address - Persian: بلوار کشاورز، نبش خیابان قدس، سازمان مرکزی دانشگاه، طبقه ششم معاونت تحقیقات و فناوری
City - English: tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1416634793
Phone: +98 21 8163 3698
Fax:
Email: vcr@sina.tums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Akbar Fotouhi
Full name of responsible person - Persian: اكبر فتوحي
Street address - English: Keshavarz Blvd., corner of Quds St., Central Organization of the University, 6th floor
Street address - Persian: بلوار کشاورز، نبش خیابان قدس، سازمان مرکزی دانشگاه، طبقه ششم معاونت تحقیقات و فناوری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1416634793
Phone: +98 21 8163 3698
Fax:
Email: vcr@sina.tums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: akbar fotouhiAkbar Fotouhi Full name of responsible person - Persian: اكبر فتوحي Street address - English: Keshavarz Blvd., corner of Quds St., Central Organization of the University, 6th floor Street address - Persian: بلوار کشاورز، نبش خیابان قدس، سازمان مرکزی دانشگاه، طبقه ششم معاونت تحقیقات و فناوری City - English: tehranTehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1416634793 Phone: +98 21 8163 3698 Fax: Email: vcr@sina.tums.ac.ir Web page address:
Protocol summary
Study aim
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
Design
Non-blind clinical trial on 44 elderly patients admitted to the intensive care unit of hospitals affiliated to Tehran University of Medical Sciences
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
Group A (receiving ketamine at a dose of 20 mg Intravenously) and group B (receiving haloperidol 2.5 mg intramuscularly)
Main outcome variables
Reynolds and Richmond Score
General information
Reason for update
Changing the blinding process
Acronym
IRCT registration information
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
Registration date
2023-05-27, 1402/03/06
Registrant information
Name
Seyed Khalil Pestehei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1560
Email address
khalilpesteh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-05, 1399/12/15
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
2021-03-05, 1399/12/15
Actual recruitment end date
2022-03-06, 1400/12/15
Trial completion date
2022-03-21, 1401/01/01
Scientific title
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
Public title
Low-dose intravenous ketamine with haloperidol in reducing delirium and agitation
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
44
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran
Street address
Tehran, end of Keshavarz Boulevard, Imam Khomeini Hospital
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2021-03-03, 1399/12/13
Ethics committee reference number
IR.TUMS.IKHC.REC.1399.548
Health conditions studied
1
Description of health condition studied
Delirium in elderly patients
ICD-10 code
F05
ICD-10 code description
Delirium, not induced by alcohol and other psychoactive substances
2
Description of health condition studied
Agitation in elderly patients
ICD-10 code
R45.1
ICD-10 code description
Restlessness and agitation
Primary outcomes
1
Description
Reynolds and Richmond score less than one
Timepoint
At the beginning of the study (before the injection) and again at 5, 10, 15 minutes after the injection
Method of measurement
Reynolds and Richmond Score
Secondary outcomes
1
Description
The duration of reaching a Reynolds and Richmond score less than one
Timepoint
At the beginning of the study (before the injection) and again at 5, 10, 15 minutes after the injection
Method of measurement
Reynolds and Richmond Score
2
Description
Side effects
Timepoint
60 minutes after the start of the intervention
Method of measurement
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
Description
Intervention group 1: receiving haloperidol 2.5 mg intramuscularly
Category
Treatment - Drugs
2
Description
Intervention group 2: receiving ketamine at a dose of 20 mg