Protocol summary

Study aim
The purpose of this study will be to assess the effect ofdifferent dosages of prophylactic phenylephrine infusion effect on hypotension in elderly patients under spinal anesthesia in orthopedic surgeries
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 under spinal anesthesia in orthopedic surgeries 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. Hemodynamic changes during surgery will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria : over 60 years, American Society of Anesthesiologists physical status classification I and II, Patients under spinal anesthesiaAges 1 to 60 Exclusion criteria:Heart rate less than 45, Drug sensitivity to local anesthetics, Existence of uncontrolled systemic diseases such as diabetes or high blood pressure, Heart disease such as heart failure or arrhythmias, History of neurological or psychological diseases, Existence of any contraindications to performing spinal anesthesia
Intervention groups
Intervention group(A):Phenylephrine will be injected intravenously in 10 cc syringes containing 10 mg / ml in 100 ml of normal saline and Intervention group(B):Phenylephrine will be injected intravenously in 10 cc syringes containing 10 mg / ml in 200 ml of normal saline immediately after changing position to supine position
Main outcome variables
Mean blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220612055143N1
Registration date: 2022-06-18, 1401/03/28
Registration timing: prospective

Last update: 2022-06-18, 1401/03/28
Update count: 0
Registration date
2022-06-18, 1401/03/28
Registrant information
Name
Mitra Golmohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 8967
Email address
mitragolmohammadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the different dosages of prophylactic phenylephrine infusion effect on hypotension in elderly patients under spinal anesthesia in orthopedic surgeries
Public title
Evaluation the effect of different dosages of prophylactic phenylephrine infusion effect on hypotension during surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years American Society of Anesthesiologists physical status classification I and II Patients under spinal anesthesia
Exclusion criteria:
Heart rate less than 45 Drug sensitivity to local anesthetics Existence of uncontrolled systemic diseases such as diabetes or high blood pressure Heart disease such as heart failure or arrhythmias History of neurological or psychological diseases Existence of any contraindications to performing spinal anesthesia
Age
From 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
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 phenylephrine 10mg / ml in 100 ml of normal saline(group A) and phenylephrine 10mg / ml in 200 ml of normal saline (group B) 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. phenylephrine 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
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commitee of Urmia University of Medical Sciences
Street address
Orjanse alley, Resalat blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2022-05-28, 1401/03/07
Ethics committee reference number
1401.111.IR.UMSU.REC

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
In the first 10 minutes every minute and then every 5 minutes until the end of the operation
Method of measurement
None invasive blood pressure

2

Description
Mean Pulse rate
Timepoint
In the first 10 minutes every minute and then every 5 minutes until the end of the operation
Method of measurement
Electrocardiogram

Secondary outcomes

1

Description
nausea and vomiting
Timepoint
During operation
Method of measurement
patient observation

Intervention groups

1

Description
Intervention group: Phenylephrine, manufactured by BB Pharma, will be injected intravenously in 10 cc syringes containing 10 mg / ml in 100 ml of normal saline immediately after changing position to supine position.
Category
Prevention

2

Description
Intervention group:Phenylephrine, manufactured by BB Pharma, will be injected intravenously in 10 cc syringes containing 10 mg / ml in 200 ml of normal saline immediately after changing position to supine position.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Operating room, Khomeini Hospital
Full name of responsible person
Mitra Golmohammadi
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
Web page address

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?
Yes
Title of funding source
Oroumia 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
Mitra Golmohammadi
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
mitragolmohammadi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mitra Golmohammadi
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
mitragolmohammadi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mitra Golmohammadi
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
Email
mitragolmohammadi@yahoo.com

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
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