The purpose of this study will be to assess the effect of ephedrine and placebo on hemodynamic changes in patients undergoing percutaneous nephrolithotomy with spinal anesthesia
Design
Clinical trial with two arm parallel groups, randomised trial with double blinded assessment. Study phase will be 2-3.
Settings and conduct
In Urmia Imam Khomeini hospital operating room the patients with undergoing percutaneous nephrolithotomy with spinal anesthesia will be divided into two parallel groups (30 patients each group). The drug will be administered by the nurse , the anesthesiologist will be unaware which patient will be assigned to which group. Drug containers will be identical and only the nurse will know about the contents of each of them, and finally, after collecting information by the resident in training in anesthesiology, the anesthesiology specialist will be informed of the group each patient is assigned to. After surgery shoulder pain will be compared with each other.
Participants/Inclusion and exclusion criteria
Inclusion criteria :aged 20 to 60 years, American Society of Anesthesiologists physical status classification I and II, Patients under spinal anesthesia, Stones larger than 10 mm in lower calyx and large stones Impacted in proximal ureter Exclusion criteria:Patients with pilocalis stones larger than 20 mm and Extracorporeal Shock Wave Lithotripsy resistant 10-20 mm stones, patient with unmodified coagulopathy, patient with untreated active urinary tract infection, Patients with skeletal deformity, Patients with a history of drug allergy, In in patient with high volume bleeding and need for blood transfusion
Intervention groups
Intervention group: Will receive Ephedrine 10 mg before changing lithotomy position to supine supine. Intervention group2: Will receive Placebo before changing lithotomy position to supine
Main outcome variables
Mean blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160430027677N21
Registration date:2022-02-28, 1400/12/09
Registration timing:prospective
Last update:2022-02-28, 1400/12/09
Update count:0
Registration date
2022-02-28, 1400/12/09
Registrant information
Name
Shahryar Sane
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 4897
Email address
sane.sh@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ephedrine and placebo on hemodynamic changes in patients undergoing percutaneous nephrolithotomy with spinal anesthesia
Public title
Evaluation the effect of ephedrine on intraoperative blood pressure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
aged 20 to 60 years
American Society of Anesthesiologists physical status classification I and II
Patients under spinal anesthesia
Stones larger than 10 mm in lower calyx and large stones Impacted in proximal ureter
Exclusion criteria:
Patients with pilocalis stones larger than 20 mm and Extracorporeal Shock Wave Lithotripsy resistant 10-20 mm stones
patient with unmodified coagulopathy
patient with untreated active urinary tract infection
Patients with skeletal deformity
Patients with a history of drug allergy
patient with high volume bleeding and need for blood transfusion
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The number of patients in this study will be 60. This number of patients will be exclusive randomly assigned into two groups of ephedrine (group H) and placebo (group P) using Random Allocation Software 2.0, and the target codes will be written and placed in sealed envelopes with sequential allocation using double-blind method.
Blinding (investigator's opinion)
Double blinded
Blinding description
The anesthesiologist will be unaware of which patient will be assigned to which group. Ephedrine and placebo syringes will be identical and only the operating room will knew about the contents of each of them, and finally, after collecting information from the anesthesia residents, the anesthesiologist will be informed of the group each patient will be assigned to.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research ethics commitees of islamic Azad university_ Tabriz Branch
Street address
Pasdaran blvd, Islamic Azad university_ Tabriz Branch
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Approval date
2021-09-14, 1400/06/23
Ethics committee reference number
IR.IAU.TABRIZ.rec.1400.082
Health conditions studied
1
Description of health condition studied
blood pressure during surgery
ICD-10 code
I95.2
ICD-10 code description
Hypotension due to drugs
Primary outcomes
1
Description
Mean blood pressure
Timepoint
During operation every 3 minutes after drug injection
Method of measurement
None invasive blood pressure
Secondary outcomes
1
Description
Pulse rate
Timepoint
During operation every 3 minutes after drug injection
Method of measurement
Electrocardiogram
2
Description
nausea and vomiting
Timepoint
During operation
Method of measurement
patient observation
Intervention groups
1
Description
Intervention group: Ephedrine drug with the name of BB Pharma manufacturer in the form of 5 cc syringes containing 5 ml solutions diluted with water, 10 mg of ephedrine prepared per 1cc will be injected intravenously immediately after changing the lithotomy position to the supine position. The injection will be given once.
Category
Prevention
2
Description
Control group: Placebo syringes are 5 cc syringes containing distilled water and immediately after changing the lithotomy position to the supine position, 1cc will be injected intravenously.The injection will be given once.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Operating room, Khomeini Hospital
Full name of responsible person
Shahryar Sane
Street address
Ershad blvd, Modarres blvd
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3346 9931
Fax
+98 44 3346 8967
Email
emam-h-urm@umsu.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saber Gholizadeh
Street address
Orjanse alley, Resalat blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3223 4897
Email
research@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
urmia 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
Oroumia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Orjanse alley, Resalat blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3346 8967
Email
sanesh@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Orjanse alley, Resalat blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3346 8967
Email
sanesh@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Orjanse alley, Resalat blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3346 8967
Email
sanesh@umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available