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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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)
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
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Iran 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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
No - There is not a plan to make this available
-
Statistical Analysis Plan
-
Not applicable
-
Informed Consent Form
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Not applicable
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable
-
Title and more details about the data/document
-
-Only a part of the data, such as the information related to the main result or the like, can be shared.
-
When the data will become available and for how long
-
Access period 6 months after publication of results
-
To whom data/document is available
-
-It will be available only to researchers working in academic and scientific institutions.
-
Under which criteria data/document could be used
-
-No special conditions are considered.
-
From where data/document is obtainable
-
Person responsible for the study: Maryam Aligholizadeh
gholizade001@gmail.com
-
What processes are involved for a request to access data/document
-
After receiving the applicant's email, the documents will be sent in a short period of time.
-
Comments
-