To compare intraoperative parameters and postoperative outcomes in ureteroscopy under general anesthesia and spinal anesthesia
Design
Clinical trial with 2 groups, with parallel groups (general anesthesia, spinal anesthesia), without blinding, randomized, phase 2 on 160 patients. Using random numbers generated by the calculator
Settings and conduct
Place of operation: Urology operating room of Bahoner Hospital, Kerman. Patients are divided into two groups with general and spinal anesthesia. No blinding.
Participants/Inclusion and exclusion criteria
Entry conditions: Suffering from proximal ureteral stones with a diameter greater than 10 mm; Age more than 18 years
Stones less than 10 mm in diameter that did not respond to medical treatment; Grade I or II status according to American Society of Anesthesiologists criteria.
Conditions of non-entry: Underlying diseases that involve high-risk surgery for the patient; Suffering from contraindications to general anesthesia due to severe cardiopulmonary disease attack; Contraindications of spinal anesthesia from coagulopathy attack, hypovolemia, or lumbar skin infection. Unwillingness of patients to participate in the study.
Intervention groups
Intervention group 1: General anesthesia in these patients is administered with fentanyl at a dose of 2 µg/Kg, midazolam at a dose of 0.04 mg/Kg, Nestonal at a dose of 4 mg/Kg, atracurium at a dose of 0.5 mg/Kg, and lidocaine at a dose of 1 mg/Kg. After induction of anesthesia, patients are intubated and surgery is started. Intervention group 2: Patients are subjected to spinal anesthesia from the L4 level with a needle number 25 and with three milliliters of marcaine, and midazolam combination is used for sedation during surgery for patients.
Main outcome variables
Cleansing kidney stones
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240429061585N1
Registration date:2024-07-27, 1403/05/06
Registration timing:prospective
Last update:2024-07-27, 1403/05/06
Update count:0
Registration date
2024-07-27, 1403/05/06
Registrant information
Name
Hamed Zanganeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 1111
Email address
dr82_zanganeh@yhaoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-15, 1403/05/25
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intraoperative parameters and postoperative outcomes in ureteroscopy under general anesthesia and spinal anesthesia
Public title
Comparing the results of urinary tract observation under general and spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with proximal ureteral stones with a diameter greater than 10 mm
Age more than 18 years
Stones less than 10 mm in diameter that did not respond to medical treatment
Grade I or II status according to American Society of Anesthesiologists criteria.
Exclusion criteria:
Underlying diseases that make surgery a high risk for the patient
Suffering from contraindications to general anesthesia due to severe cardiopulmonary disease attack
Contraindications of spinal anesthesia from coagulopathy attack, hypovolemia, or lumbar skin infection.
Unwillingness of patients to participate in the study.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is simple and the table of random numbers generated by the calculator is used so that odd numbers are placed in the first intervention group and even numbers are placed in the second intervention group.
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
Research Ethics Committees of Afzalipour Hospital - Kerman University of Medical sciences
Street address
Clinical Research Development Unit, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913911
Approval date
2024-07-11, 1403/04/21
Ethics committee reference number
IR.KMU.AH.REC.1403.068
Health conditions studied
1
Description of health condition studied
Calculus of ureter
ICD-10 code
N20.1
ICD-10 code description
Calculus of ureter
Primary outcomes
1
Description
Clearing kidney stones
Timepoint
Two weeks after the operation
Method of measurement
Using a spiral CT scan of the abdomen and pelvis without contrast material
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: General anesthesia in these patients is given with fentanyl at a dose of 2 µg/Kg, midazolam at a dose of 0.04 mg/Kg, Nestonal at a dose of 4 mg/Kg, atracurium at a dose of 0.5 mg/Kg, and lidocaine at a dose of 1 mg/Kg. After induction of anesthesia, patients are intubated and surgery is started.
Category
Treatment - Drugs
2
Description
Intervention group: Patients are subjected to spinal anesthesia from the L4 level with a needle number 25 and with three milliliters of marcaine, and midazolam combination is used for sedation during surgery for patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital
Full name of responsible person
Amir Reza Sadeghi Far
Street address
Kerman, Qarani St. - Shahid Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
bahonarh@kmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Research and Technology Office, Samiya Crossroads (Tahmasababad), at the beginning of Ibn Sina Street, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Email
VCR@KMU.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Hamed Zanganeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Bahonar hospital, Qarani Street
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Fax
Email
dr82_zanganeh@yhaoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hamid Pakmanesh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Bahonar hospital, Qarani Street
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3322 2250
Email
hamid.pakmanesh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hamed Zanganeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Bahonar hospital, Qarani Street
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Fax
Email
dr82_zanganeh@yhaoo.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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
At the end of the study, part of the information including intraoperative parameters and postoperative outcomes in ureteroscopy under general anesthesia and spinal anesthesia after de-identifying the subjects will be shared with those interested in the field of treatment.
When the data will become available and for how long
2 to 6 months after the statistical analysis of the data
To whom data/document is available
Doctors and researchers offer treatment
Under which criteria data/document could be used
In order to use the results and during the written request
What processes are involved for a request to access data/document
The purpose of accessing and using the data is to request an email to the author, a second email in case of no response as a reminder, to confirm the identity of the requester by the public respondent, to send the documentation file.