Investigating the safety and effect of prophylactic doses of neostigmine in the prevention of postoperative ileus after radical cystectomy - a randomized clinical trial
Investigating the effect of prophylactic use of neostigmine in the prevention of postoperative ileus after radical cystectomy
Design
A randomized, blinded, controlled clinical trial with parallel groups on 80 patients. The rand function of Excel software was used for randomization.
Settings and conduct
Shahid Beheshti University of Medical Sciences' referral hospitals
After surgery, patients are prescribed neostigmine or placebo and are followed up in terms of outcomes such as the development of ileus or the time of PO.
Patients are blinded to which group they belong.
Participants/Inclusion and exclusion criteria
All patients candidate for radical cystectomy include but patients with epilepsy, convulsion, cardiac arrhythmia and respiratory problem will be excluded
Intervention groups
Radical cystectomy candidate patients are randomly divided into two groups. After surgery, one group is administered 1 mg of intravenous neostigmine and the other group is administered normal saline serum. Both groups are monitored for the duration of ileus and complications.
Main outcome variables
Age, Diversion type, Extra or intraperitoneal technique, Operation time, Adverse effect of neostigmine, Time to gas passage, Time to defecation, Time to PO tolerance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170826035911N2
Registration date:2025-03-24, 1404/01/04
Registration timing:prospective
Last update:2025-03-24, 1404/01/04
Update count:0
Registration date
2025-03-24, 1404/01/04
Registrant information
Name
Farzad Allameh
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 6386
Email address
farzadallameh@sbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-03-30, 1404/01/10
Expected recruitment end date
2025-05-22, 1404/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the safety and effect of prophylactic doses of neostigmine in the prevention of postoperative ileus after radical cystectomy - a randomized clinical trial
Public title
Investigating the safety and effect of prophylactic doses of neostigmine in the prevention of postoperative ileus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients fit for Radical Cystectomy
Exclusion criteria:
Patients with the history of convulsion, epilepsy, cardiac arrhythmia and respiratory problems
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization was conducted using the randomization function available in Microsoft Excel. This approach ensured an unbiased selection of participants/experimental units, thereby enhancing the validity of the findings.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients included in the study are randomly divided into two groups. One group is prescribed intravenous Neostigmine injected into the serum and the other group receives only normal saline serum. Patients are blinded to which group they belong.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical SciencesLaser application in medical sciences research center
Street address
Tajrish Sq.
City
Tehran
Province
Tehran
Postal code
1989934148
Approval date
2023-10-25, 1402/08/03
Ethics committee reference number
IR.SBMU.LASER.REC.1402.025
Health conditions studied
1
Description of health condition studied
Muscle Invasive bladder cancer
ICD-10 code
C67
ICD-10 code description
Malignant neoplasm of bladder
Primary outcomes
1
Description
Ileus recovery
Timepoint
Second day after operation
Method of measurement
History and physical exam
2
Description
Adverse effects
Timepoint
After administration and till 7 days
Method of measurement
History and physical exam
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One milligram of neostigmine is infused in 30 minutes
Category
Treatment - Drugs
2
Description
Control group: Under the same conditions as the Intervention group, they undergo a placebo infusion in normal saline.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres hospital
Full name of responsible person
Farzad Allameh
Street address
Modarres hospital, Seadat abad, Tehran
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 912 388 5545
Email
farzadallame@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Razzaghi
Street address
Shohada-e-Tajrish hospital, Tajrish Sq., Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
z.razaghi@gmail.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
Farzad Allameh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shohda-e-Tajrish hospital, Tajrish Sq., Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 912 388 5545
Email
farzadallame@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzad Allameh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shohada-e Tajrish hospital, Tajrish Sq.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 912 388 5545
Email
farzadallame@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzad Allameh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shohada-e-Tajrish hospital, Tajrish Sq.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 912 388 5545
Email
farzadallame@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
SPSS dataset including patients characteristics without names
When the data will become available and for how long
After data collection
To whom data/document is available
Research center supervisor
Under which criteria data/document could be used
According to research center protocol
From where data/document is obtainable
Laser Application in Medical Sciences Research Center
What processes are involved for a request to access data/document