The effect of prescribing intravenous ketamine during induction of anesthesia on the incidence of delirium and the time of endotracheal tube removal in patients undergoing coronary artery bypass surgery
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
A clinical trial with a control group, three blinded, randomized, phase 3 will be conducted on 60 patients. The rand function of Excel software will be used for randomization.
A clinical trial with a control group, three blinded, randomized, phase 3 will be conducted on 100 patients. The rand function of Excel software will be used for randomization.
A clinical trial with a control group, three blinded, randomized, phase 3 will be conducted on 60100 patients. The rand function of Excel software will be used for randomization.
کارآزمایی بالینی دارای گروه کنترل، سه سویه کور ، تصادفی شده، فاز 3 بر روی 60 بیمار انجام خواهد شد. برای تصادفی سازی از فانکشن rand نرم افزار اکسل استفاده خواهد شد.
کارآزمایی بالینی دارای گروه کنترل، سه سویه کور ، تصادفی شده، فاز 3 بر روی 100 بیمار انجام خواهد شد. برای تصادفی سازی از فانکشن rand نرم افزار اکسل استفاده خواهد شد.
کارآزمایی بالینی دارای گروه کنترل، سه سویه کور ، تصادفی شده، فاز 3 بر روی 60100 بیمار انجام خواهد شد. برای تصادفی سازی از فانکشن rand نرم افزار اکسل استفاده خواهد شد.
این مطالعه یک کارآزمایی بالینی سه سوکور است. مجری پژوهش از نوع مداخله در گروه‌ها اطلاعی ندارند. بیماران اطلاعی از نوع گروه داروها ندارند. پزشک متخصص بیهوشی تجویزکننده دارو و شخص ارزیاب کننده بیمار مجزا خواهند بود. همچنین تحلیلگر آماری نیز از گروه و درمان‌های بیماران بی‌اطلاع خواهد بود.
پس از اخذ تاییدیه اخلاقی، 60 کاندید واجد شرایط از طریق تصادفی سازی بلوک، بیماران پس از کسب رضایت آگاهانه در دو گروه کتامین یا دارونما قرار خواهند گرفت.دلیریوم با استفاده از ابزار ICDSC در 24 و 48 ساعت پس از پذیرش، همراه با ثبت زمان اکستیوب ارزیابی می‌شود.
این مطالعه یک کارآزمایی بالینی سه سوکور است. مجری پژوهش از نوع مداخله در گروه‌ها اطلاعی ندارند. بیماران اطلاعی از نوع گروه داروها ندارند. پزشک متخصص بیهوشی تجویزکننده دارو و شخص ارزیاب کننده بیمار مجزا خواهند بود. همچنین تحلیلگر آماری نیز از گروه و درمان‌های بیماران بی‌اطلاع خواهد بود.
پس از اخذ تاییدیه اخلاقی، 100 کاندید واجد شرایط از طریق تصادفی سازی بلوک، بیماران پس از کسب رضایت آگاهانه در دو گروه کتامین یا دارونما قرار خواهند گرفت.دلیریوم با استفاده از ابزار ICDSC در 24 و 48 ساعت پس از پذیرش، همراه با ثبت زمان اکستیوب ارزیابی می‌شود.
این مطالعه یک کارآزمایی بالینی سه سوکور است. مجری پژوهش از نوع مداخله در گروه‌ها اطلاعی ندارند. بیماران اطلاعی از نوع گروه داروها ندارند. پزشک متخصص بیهوشی تجویزکننده دارو و شخص ارزیاب کننده بیمار مجزا خواهند بود. همچنین تحلیلگر آماری نیز از گروه و درمان‌های بیماران بی‌اطلاع خواهد بود. پس از اخذ تاییدیه اخلاقی، 60100 کاندید واجد شرایط از طریق تصادفی سازی بلوک، بیماران پس از کسب رضایت آگاهانه در دو گروه کتامین یا دارونما قرار خواهند گرفت.دلیریوم با استفاده از ابزار ICDSC در 24 و 48 ساعت پس از پذیرش، همراه با ثبت زمان اکستیوب ارزیابی می‌شود.
The number of 60 patients who are candidates for CABG surgery are divided into two groups receiving ketamine and the placebo group. Patients who, after induction of anesthesia, receive an intravenous dose of ketamine with a dose of 0.5 mg/kg to a maximum of 50 mg as an infusion in 100 cc of serum in a maximum time of 5 minutes; Ketamine group and patients who receive the same volume of 0.9 normal saline as placebo are called placebo group.
The number of 100 patients who are candidates for CABG surgery are divided into two groups receiving ketamine and the placebo group. Patients who, after induction of anesthesia, receive an intravenous dose of ketamine with a dose of 0.5 mg/kg to a maximum of 50 mg as an infusion in 100 cc of serum in a maximum time of 5 minutes; Ketamine group and patients who receive the same volume of 0.9 normal saline as placebo are called placebo group.
The number of 60100 patients who are candidates for CABG surgery are divided into two groups receiving ketamine and the placebo group. Patients who, after induction of anesthesia, receive an intravenous dose of ketamine with a dose of 0.5 mg/kg to a maximum of 50 mg as an infusion in 100 cc of serum in a maximum time of 5 minutes; Ketamine group and patients who receive the same volume of 0.9 normal saline as placebo are called placebo group.
تعداد 60نفر از بیماران کاندید جراحیCABGبه دو گروه دریافت کننده کتامین و گروه دارونما تقسیم می‌شوند. بیمارانی که پس از القاء بیهوشی یک دوز داخل وریدی کتامین با دوز 0/5mg/kg تا حداکثر 50mg بصورت انفوزیون در ۱۰۰cc سرم در حداکثر زمان ۵ دقیقه دریافت می‌کنند؛ گروه کتامین و بیمارانی که همان حجم از دارونمای نرمال‌سالین۰/۹ به عنوان دارونما دریافت می‌کنند، گروه پلاسبو نامیده می‌شوند.
تعداد 100نفر از بیماران کاندید جراحیCABGبه دو گروه دریافت کننده کتامین و گروه دارونما تقسیم می‌شوند. بیمارانی که پس از القاء بیهوشی یک دوز داخل وریدی کتامین با دوز 0/5mg/kg تا حداکثر 50mg بصورت انفوزیون در ۱۰۰cc سرم در حداکثر زمان ۵ دقیقه دریافت می‌کنند؛ گروه کتامین و بیمارانی که همان حجم از دارونمای نرمال‌سالین۰/۹ به عنوان دارونما دریافت می‌کنند، گروه پلاسبو نامیده می‌شوند.
تعداد 60نفر100نفر از بیماران کاندید جراحیCABGبه دو گروه دریافت کننده کتامین و گروه دارونما تقسیم می‌شوند. بیمارانی که پس از القاء بیهوشی یک دوز داخل وریدی کتامین با دوز 0/5mg/kg تا حداکثر 50mg بصورت انفوزیون در ۱۰۰cc سرم در حداکثر زمان ۵ دقیقه دریافت می‌کنند؛ گروه کتامین و بیمارانی که همان حجم از دارونمای نرمال‌سالین۰/۹ به عنوان دارونما دریافت می‌کنند، گروه پلاسبو نامیده می‌شوند.
General information
60
100
60100
empty
100
100
empty
2024-03-10, 1402/12/20
2024-03-10 00:00:00
empty
2025-01-01, 1403/10/12
2025-01-01 00:00:00
empty
2025-01-20, 1403/11/01
2025-01-20 00:00:00
empty
To improve the statistical power of the study and enhance the precision of effect size estimation, the sample size was increased from 60 to 100 participants. Preliminary analyses indicated that the initial sample size was insufficient to detect statistically significant differences between the study groups. Therefore, the sample size was revised to reduce the risk of Type II error and to improve the reliability and generalizability of the study findings. No other changes were made to the study design, including inclusion and exclusion criteria, intervention protocols, or group allocation methods.
To improve the statistical power of the study and enhance the precision of effect size estimation, the sample size was increased from 60 to 100 participants. Preliminary analyses indicated that the initial sample size was insufficient to detect statistically significant differences between the study groups. Therefore, the sample size was revised to reduce the risk of Type II error and to improve the reliability and generalizability of the study findings. No other changes were made to the study design, including inclusion and exclusion criteria, intervention protocols, or group allocation methods.
empty
به‌منظور افزایش دقت برآورد اثر مداخله و ارتقای توان آماری مطالعه، حجم نمونه پژوهش از 60 نفر به 100 نفر افزایش یافت. بررسی نتایج تحلیل‌های اولیه نشان داد که حجم نمونه قبلی برای شناسایی تفاوت‌های معنادار آماری بین گروه‌ها کفایت لازم را نداشته است. بنابراین، به‌منظور کاهش احتمال خطای نوع دوم (Type II error) و افزایش قابلیت تعمیم‌پذیری نتایج، حجم نمونه اصلاح و افزایش داده شد. لازم به ذکر است که سایر اجزای طراحی مطالعه، شامل معیارهای ورود و خروج، روش تخصیص گروه‌ها و مداخلات، بدون تغییر باقی مانده‌اند.
به‌منظور افزایش دقت برآورد اثر مداخله و ارتقای توان آماری مطالعه، حجم نمونه پژوهش از 60 نفر به 100 نفر افزایش یافت. بررسی نتایج تحلیل‌های اولیه نشان داد که حجم نمونه قبلی برای شناسایی تفاوت‌های معنادار آماری بین گروه‌ها کفایت لازم را نداشته است. بنابراین، به‌منظور کاهش احتمال خطای نوع دوم (Type II error) و افزایش قابلیت تعمیم‌پذیری نتایج، حجم نمونه اصلاح و افزایش داده شد. لازم به ذکر است که سایر اجزای طراحی مطالعه، شامل معیارهای ورود و خروج، روش تخصیص گروه‌ها و مداخلات، بدون تغییر باقی مانده‌اند.
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Shahnam Sedigh Maroufi
Full name of responsible person - Persian: شهنام صدیق معروفی
Street address - English: Hemmt Ave, Department of Anesthesia Technology, School of Allied Medical Sciences, Iran University of Medical Sciences
Street address - Persian: بزرگراه همت، دانشگاه علوم پزشکی ایران، دانشکده پیراپزشکی، گروه هوشبری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8670 4711
Fax:
Email: paramedicine@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mehrdad Mesbah kiaei
Full name of responsible person - Persian: مهرداد مصباح کیایی
Street address - English: Hemmt Ave, Department of Anesthesia Technology, School of Allied Medical Sciences, Iran University of Medical Sciences
Street address - Persian: بزرگراه همت، دانشگاه علوم پزشکی ایران، دانشکده پیراپزشکی، گروه هوشبری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8670 4711
Fax:
Email: paramedicine@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Shahnam Sedigh MaroufiMehrdad Mesbah kiaei Full name of responsible person - Persian: شهنام صدیق معروفیمهرداد مصباح کیایی Street address - English: Hemmt Ave, Department of Anesthesia Technology, School of Allied Medical Sciences, Iran University of Medical Sciences Street address - Persian: بزرگراه همت، دانشگاه علوم پزشکی ایران، دانشکده پیراپزشکی، گروه هوشبری City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1449614535 Phone: +98 21 8670 4711 Fax: Email: paramedicine@iums.ac.ir Web page address:
Protocol summary
Study aim
the effect of prescribing intravenous ketamine during induction of anesthesia on the incidence of delirium and the time of endotracheal tube removal in patients undergoing coronary artery bypass surgery
Design
A clinical trial with a control group, three blinded, randomized, phase 3 will be conducted on 100 patients. The rand function of Excel software will be used for randomization.
Settings and conduct
This study is a three-blind clinical trial. The researcher and the patients do not know the type of intervention in the groups. The anesthesiologist who prescribes the medicine and the person who evaluates the patient will be separate. The statistical analyst will also be unaware of the group and treatments of the patients. Through block randomization, patients will be placed in two groups of ketamine or placebo. Incidence of delirium and extubation time will be evaluated.
Participants/Inclusion and exclusion criteria
Entry criteria: ages between 40 and 80 years old, ASA class l, ll and lll
Exclusion criteria: history of postoperative delirium, underlying mental illness, use of antipsychotic drugs, postoperative bleeding, valvular surgery, need for re-surgery
Intervention groups
The number of 100 patients who are candidates for CABG surgery are divided into two groups receiving ketamine and the placebo group. Patients who, after induction of anesthesia, receive an intravenous dose of ketamine with a dose of 0.5 mg/kg to a maximum of 50 mg as an infusion in 100 cc of serum in a maximum time of 5 minutes; Ketamine group and patients who receive the same volume of 0.9 normal saline as placebo are called placebo group.
Main outcome variables
Registration of delirium in the relevant checklist during the first 24 and 48 hours of admission to the intensive care unit
General information
Reason for update
To improve the statistical power of the study and enhance the precision of effect size estimation, the sample size was increased from 60 to 100 participants. Preliminary analyses indicated that the initial sample size was insufficient to detect statistically significant differences between the study groups. Therefore, the sample size was revised to reduce the risk of Type II error and to improve the reliability and generalizability of the study findings. No other changes were made to the study design, including inclusion and exclusion criteria, intervention protocols, or group allocation methods.
Acronym
IRCT registration information
IRCT registration number:IRCT20231021059795N1
Registration date:2024-04-20, 1403/02/01
Registration timing:registered_while_recruiting
Last update:2026-06-20, 1405/03/30
Update count:1
Registration date
2024-04-20, 1403/02/01
Registrant information
Name
Maryam Aligholizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4351 2673
Email address
gholizade001@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-09, 1403/01/21
Expected recruitment end date
2024-05-10, 1403/02/21
Actual recruitment start date
2024-03-10, 1402/12/20
Actual recruitment end date
2025-01-01, 1403/10/12
Trial completion date
2025-01-20, 1403/11/01
Scientific title
The effect of prescribing intravenous ketamine during induction of anesthesia on the incidence of delirium and the time of endotracheal tube removal in patients undergoing coronary artery bypass surgery
Public title
The effect of prescribing intravenous Ketamine in the anesthesia of patients undergoing coronary artery bypass surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Ages between 40 and 80 years
ASA class l, ll lll
Exclusion criteria:
Having a history of postoperative delirium
The presence of underlying mental illness
Taking antipsychotic drugs
Having a history of alcohol consumption
Presence of cerebrovascular disease
Perform valvular surgery
BMI > 38 kg/m2
Postoperative stroke
Postoperative bleeding
Longer operation time than usual
Need for re-surgery
History of underlying lung disease
Age
From 40 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method will be used using blocks of six in random order. Then the patients who will meet the entry criteria; According to the block randomization method, they will be placed in groups (in this method, the treatment blocks are moved back and forth randomly and different situations can be created with blocks of length 6 for two groups, for example: ABCABC-BACABC-ABCBAC-ABCCBA... and The mentioned situations continue until the sample volume is filled). Blocks will be randomly selected with Excel software and at the disposal of a researcher who has no involvement in choosing the type of intervention; Placed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
A numerical code will be assigned to each of the rings of the randomly generated chains. Then, the drug regimen is placed in envelopes according to random chains, and after sealing it, a specific number is written on the envelopes, and these envelopes are placed in a box in random order.
Blinding: This research will be triple blind.
The researcher does not know the type of intervention in the groups.
Patients do not know the type of drug group.
The anesthesiologist who prescribes the drug and the person who evaluates the patient will be separate, and the patient's information will be recorded based on the ICDSC checklist and the time of extraction by the trained nurses of the special care department who have received sufficient training and explanations before the research and from the group and treatments. Patients are unaware. Also, the statistical analyst will be unaware of the group and treatments of the patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmt Ave, Department of Anesthesia Technology, School of Allied Medical Sciences, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-12-31, 1402/10/10
Ethics committee reference number
IR.IUMS.REC.1402.833
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia
2
Description of health condition studied
Extubation time
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Incidence rate of delirium after cardiac surgery
Timepoint
In the first 24 hours and the second 24 hours after the operation
Method of measurement
Intensive Care Delirium Screening Checklist (ICDSC)
2
Description
Extubation time
Timepoint
Up to the first 12 hours of the postoperative period
Method of measurement
Registering patients' extubation time (according to hours: during the first 4 hours after entering the ward, the first 6 hours after entering the ward, the first 8 hours after entering the ward, the first 12 hours after entering the ward)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intravenous ketamine with a dose of 0.5mg/kg up to a maximum of 50mg will be administered as an infusion in 100cc of 0.9% normal saline serum in a maximum time of 5 minutes during the induction of anesthesia and after the administration of anesthetic drugs.
Category
Prevention
2
Description
Control group: the same volume as the intervention group of 0.9% normal saline placebo in 100cc of 0.9% normal saline serum in a maximum time of 5 minutes as an infusion, as a placebo that will be administered during induction of anesthesia and after the administration of anesthetic drugs.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
The educational, therapeutic and research center of Hazrat Rasool Akram (PBUH)
Full name of responsible person
Mehrdad Mesbah kiaei
Street address
Tehran-Starkhan-Kh.Niyaish-Corner of Mansouri Street-Hospital of Hazrat Rasool Akram (PBUH)
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 81161
Email
Rasoolhospital@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehrdad Mesbah kiaei
Street address
Hemmt Ave, Department of Anesthesia Technology, School of Allied Medical Sciences, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4711
Email
paramedicine@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?