The effect of rivastigmine on postoperative delirium
Design
Eligible patients will be randomly divided into control and rivastigmine groups. Rivastigmine is started in the evening of the day before surgery and will continue in the pre- and postoperative periods until the evening of the sixth day after surgery. Radical surgery will be performed using standard protocol and standard anesthesia.After hydration of the patient, the appropriate size of the spiral endotracheal tube is selected for the patient. Initially, preoxygenation will be performed on the patient for 3 minutes. To induce anesthesia, a standard protocol including fentanyl at a dose of 1 to 2 micrograms per kilogram of body weight, midazolam at a dose of 3 hundred milligrams per kilogram of body weight, and lidocaine at a dose of 1 to 1.5 milligrams per kilogram of body weight will be used.
Settings and conduct
All patients over 60 years of age who are candidates for radical surgery who have referred to Shahid Modarres Hospital will be included in the study completely randomly based on the numbers in the random table of 60 of them.
Participants/Inclusion and exclusion criteria
All patients underwent radical surgery
Age over 60 years
Intervention groups
Rivastigmine is given to the patient three times a day in doses of 1.5 mg (4.5 mg per day) as an infusion before, during and after surgery and every 8 hours. The placebo given to the control group will be similar in color to rivastigmine.
Main outcome variables
Bleeding rate; Postoperative delirium; Duration of stay in the ICU; Length of hospital stay; Duration of postoperative consciousness; Postoperative nausea and vomiting; Postoperative dizziness; Train-of-four Fade evaluation; Extrusion time; The amount of drugs used; Electrolyte disturbance; hemoglobin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201211049679N1
Registration date:2021-09-22, 1400/06/31
Registration timing:registered_while_recruiting
Last update:2021-09-22, 1400/06/31
Update count:0
Registration date
2021-09-22, 1400/06/31
Registrant information
Name
kia kazemzadeh hanani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8807 6453
Email address
kiiiiia_kzm@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-11, 1400/06/20
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Rivastigmine in postoperative delirium after the Radical surgery
Public title
Effect of Rivastigmine in postoperative delirium after the Radical surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients underwent radical surgery
Age over 60 years
Exclusion criteria:
History of psychiatric disorders
Patients in need of emergency surgery
Patients with a Mini-Mental State Examination Score (MMSE) of less than 15
Current treatment with cholinesterase inhibitors
Using psychiatric drugs
Using haloperidol
Contraindication for the use of rivastigmine
Age
To 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be entered into the study completely randomly based on random table numbers. Randomization will be done by someone other than the researchers of this project.
First, each patient as a member of the community was given a three-digit code (001, 002, 003, ...). Then go to the table, select the starting point and move in the direction of the row or column based on the adjacent three-digit numbers. Select the first three-digit number smaller than the total number of patients as the first sample and ignore numbers greater than the total number of patients. We will continue to do this until we can select 60 items as a sample.
Blinding (investigator's opinion)
Double blinded
Blinding description
We do not inform the participant and researcher about the details of the drugs used (placebo and Rivastigmine). In this study, the doctor who gives the drug to the patient and only with the codes assigned to the drugs (placebo and Rivastigmine), they use them for each patient who will enter the plan and he himself is unaware of how the codes are assigned and the patient himself is the type of drugs (placebo and Rivastigmine). Consumption will be uninformed and only the project instructor will be aware of the drugs (placebo and Rivastigmine) given to patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Yemen St ,Shahid Chamran Highway
City
tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-04-21, 1399/02/02
Ethics committee reference number
IR.SBMU.MSP.REC.1399.007
Health conditions studied
1
Description of health condition studied
Patients undergoing radical surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bleeding rate
Timepoint
before and after intervention
Method of measurement
The amount of bleeding during the operation
2
Description
Postoperative delirium
Timepoint
before and after intervention
Method of measurement
Patient delirium one hour after surgery and at the time of discharge from the intensive care unit.
3
Description
Duration of stay in the ICU
Timepoint
before and after intervention
Method of measurement
Number of days the patient stays in the intensive care unit after surgery.
4
Description
Length of hospital stay
Timepoint
before and after intervention
Method of measurement
Number of days the patient stays in the hospital after surgery.
5
Description
Duration of postoperative consciousness
Timepoint
before and after intervention
Method of measurement
The number of hours the patient regains consciousness after surgery.
6
Description
Postoperative nausea and vomiting
Timepoint
before and after intervention
Method of measurement
The number of times a patient vomits after surgery until discharge from the intensive care unit.
7
Description
Postoperative dizziness
Timepoint
before and after intervention
Method of measurement
Duration of postoperative sensory disturbances and confusion.
8
Description
Train-of-four Fade evaluation
Timepoint
before and after intervention
Method of measurement
Evaluation of peripheral nerve excitability to evaluate neuromuscular block.
9
Description
Extubation time
Timepoint
before and after intervention
Method of measurement
Duration of extubation of the patient after administration of neuromuscular blocking agent.
10
Description
The amount of opiate used
Timepoint
before and after intervention
Method of measurement
The amount of opiate used after surgery.
Secondary outcomes
1
Description
Electrolyte disturbance
Timepoint
before and after intervention
Method of measurement
Having an electrolyte disorder such as hyponatremia.
2
Description
hemoglobin
Timepoint
before and after intervention
Method of measurement
Serum hemoglobin concentration
Intervention groups
1
Description
Rivastigmine (manufactured by Galenus Pharmaceutical Company) will be given to the patient three times a day in doses of 1.5 mg (4.5 mg per day) in the form of infusion before, during and after surgery and every 8 hours. Rivastigmine and placebo (prepared by Abu Reihan Pharmaceutical Company) will be administered through nasogastric tube until the patient is extubated. The given placebo will be similar in color to rivastigmine. The selective dose of rivastigmine was based on previous studies, including the study of Gamberini et al. (20). Rivastigmine is started in the evening of the day before surgery and will continue in the pre- and postoperative periods until the evening of the sixth day after surgery. Radical surgery will be performed using standard protocol and standard anesthesia. . Patients are placed in the supine position and angiocatheter 18 is implanted. After hydration of the patient, the appropriate size of the spiral endotracheal tube is selected for the patient. Initially, preoxygenation will be performed on the patient for 3 minutes. To induce anesthesia, a standard protocol including fentanyl at a dose of 1 to 2 micrograms per kilogram of body weight, midazolam at a dose of 3 hundred milligrams per kilogram of body weight, and lidocaine at a dose of 1 to 1.5 milligrams per kilogram of body weight will be used. Patients under general anesthesia with propofol 1-2 mg / kg body weight. They will also receive inhalation using isoflurane during surgery. Postoperative analgesics will include morphine and paracetamol. Also, very low doses of meperidine will be used to relieve tremors after surgery. Doses of sedatives as well as analgesics will be reported daily.
Category
Treatment - Drugs
2
Description
The given placebo will be similar in color to rivastigmine. Placebo will also be provided by Abu Reihan Pharmaceutical Company. Which will be randomly assigned to the study group as a control, the researcher will not know which type (drug or placebo) to give to the patient. The placebo is started in the evening of the day before the operation and will continue in the pre- and postoperative periods until the evening of the sixth day after the operation. The exact conditions will be the same as the administration of rivastigmine. Radical surgery will be performed using standard protocol and standard anesthesia. . Patients are placed in the supine position and angiocatheter 18 is implanted. After hydration of the patient, the appropriate size of the spiral endotracheal tube is selected for the patient. Initially, preoxygenation will be performed on the patient for 3 minutes. To induce anesthesia, a standard protocol including fentanyl at a dose of 1 to 2 micrograms per kilogram of body weight, midazolam at a dose of 3 hundred milligrams per kilogram of body weight, and lidocaine at a dose of 1 to 1.5 milligrams per kilogram of body weight will be used. Patients under general anesthesia with propofol 1-2 mg / kg body weight. They will also receive inhalation using isoflurane during surgery. Postoperative analgesics will include morphine and paracetamol. Also, very low doses of meperidine will be used to relieve tremors after surgery. Doses of sedatives as well as analgesics will be reported daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
shahid modares hospital
Full name of responsible person
kia kazemzadeh hanani
Street address
End of Saadat Abad Street - the intersection of Yadegar Imam and Saadat Abad highways
City
tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
kiiiiia_kzm@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
kia kazemzadeh hananai
Street address
Shahid Chamran Highway, Yemen St., next to Taleghani Hospital, Shahid Beheshti University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
kiiiiia_kzm@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
kia kazemzadeh hanani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Chamran Highway, Yemen St., next to Taleghani Hospital, Shahid Beheshti University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2241 0042
Email
kiiiiiia_kzm@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
kia kazemzadeh hanani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Chamran Highway, Yemen St., next to Taleghani Hospital, Shahid Beheshti University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2241 0042
Email
kiiiiia_kzm@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
kia kazemzadeh hanani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Chamran Highway, Yemen St., next to Taleghani Hospital, Shahid Beheshti University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2241 0042
Email
kiiiiia_kzm@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All collected data will be given in writing in the dissertation and articles.
When the data will become available and for how long
Summer 1401
To whom data/document is available
Everyone
Under which criteria data/document could be used
Everyone
From where data/document is obtainable
Executors and project partners
What processes are involved for a request to access data/document
By referring to Shahid Beheshti University of Medical Sciences, the dissertations section can access all the documents.