Comparative study of hemodynamic and renal effects of Pethidine and Marcaine during and after the operation in patients undergoing TUL surgery: double-blind randomized controlled clinical trial
Comparative study of hemodynamic and renal effects of Pethidine and Marcaine during and after the operation in patients undergoing TUL surgery: double-blind randomized controlled clinical trial
Design
This is a randomized clinical trial with a parallel design and a control group. This study is double-blinded that the drugs can be identified only through the serial insert on the container containing it. This study randomized, phase 2-3 will be performed on 66 patients. For randomization, a simple random method is used and participants are assigned to two intervention groups.
Settings and conduct
This study, which will be performed in Imam Reza Hospital in Kermanshah, is a double-blinded one. Participants and clinical caregivers will be kept blind in this study. Half an hour before the operation, a separate intravenous route is taken for all patients, and in case of increased blood pressure and heart rate due to anxiety and stress, 1000-500 cc of Ringer serum of 1 mg midazolam is infused.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who are candidates for TUL surgery by their doctor; Patients who are in ASA class 1 and 2;
Exclusion criteria: Patients with chronic diseases including heart disease and hypertension and advanced lung and neurological diseases;Patients taking opium;Patients who are contraindications to the spinal procedure
Intervention groups
The first intervention group will receive 15-15.5 mg of Markain 0.5% in the intervertebral space L3-L4 for spinal anesthesia by injection.
The second intervention group will receive 1 mg of Pethidine in the L3-L4 intervertebral space for spinal anesthesia by injection.
Main outcome variables
Changes in blood pressure, changes in heart rate, urinary retention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N165
Registration date:2021-04-05, 1400/01/16
Registration timing:prospective
Last update:2021-04-05, 1400/01/16
Update count:0
Registration date
2021-04-05, 1400/01/16
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-18, 1400/01/29
Expected recruitment end date
2021-07-20, 1400/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of hemodynamic and renal effects of Pethidine and Marcaine during and after the operation in patients undergoing TUL surgery: double-blind randomized controlled clinical trial
Public title
Comparative study of hemodynamic and renal effects of Pethidine and Marcaine during and after surgery in patients undergoing ureteral stone surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for TUL surgery by their doctor
Patients who are in ASA class 1 and 2
Exclusion criteria:
Patients with chronic diseases including heart disease and hypertension and advanced lung and neurological diseases
Patients taking opium
Patients who are contraindications to the spinal procedure
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in a simple random method, after identifying eligible patients, they will be randomly assigned a three-digit dedicated code. The last digit on the right determines the patient group. If this number is 0, 1, 2, 3, 4, it will be assigned in the first intervention group, and if this number is 5, 6, 7, 8, 9, it will be assigned in the second intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications can only be identified by the serial number on the container. The serials are with the main researcher and will remain confidential until the end of the study. The charge of injecting medications will not know about the assignment of individuals to groups. The person evaluating the patients will also not know about the assignment. Therefore, this study will be a double-blinded one.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-02-16, 1399/11/28
Ethics committee reference number
IR.KUMS.REC.1399.1170
Health conditions studied
1
Description of health condition studied
Urological services with urine virtual stone
ICD-10 code
N21
ICD-10 code description
Calculus of lower urinary tract
Primary outcomes
1
Description
Blood pressure changes
Timepoint
Every 5 minutes until the end of the first 30 minutes, then every 15 minutes until the end of surgery and in the recovery room every 15 minutes until the recovery criteria are met.
Method of measurement
Using a pressure gauge
2
Description
Heart rate changes
Timepoint
Every 5 minutes until the end of the first 30 minutes, then every 15 minutes until the end of surgery and in the recovery room every 15 minutes until the recovery criteria are met.
Method of measurement
Using a pulse oximeter
3
Description
Urinary retention
Timepoint
Before and after anesthesia
Method of measurement
Based on questions from the patient and based on observation and clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive 15-15.5 mg of Markain 0.5% in the intervertebral space L3-L4 for spinal anesthesia by injection.
Category
Treatment - Drugs
2
Description
The second intervention group will receive 1 mg of Pethidine in the L3-L4 intervertebral space for spinal anesthesia by injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Bahar Khodayar
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Baharkhodayar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
rkhodarahmi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Bahar Khodayar
Position
Resident of anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Baharkhodayar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Javad Amini Saman
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Aminisamanj99@Gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Bahar Khodayar
Position
Resident of anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Baharkhodayar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
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
Undecided - It is not yet known if there will be 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