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Comparison of the effect of mannitol and hypertonic sodium administration to reduce ICP on hemodynamic parameters under LiDCO monitoring in patients undergoing elective craniotomy

Protocol summary

Study aim
Comparison of the effect of mannitol and hypertonic sodium administration to reduce ICP on hemodynamic parameters under LiDCO monitoring in patients under elective craniotomy
Design
This randomized clinical trial will be conducted in 1400-1401 at Sinai Hospital. In this study, adult patients aged 18 to 65 years with ASA status I and II who are to undergo elective craniotomy will be evaluated. Patients enrolled in the study will be randomly divided into two groups: mannitol (receiving 5 ml/kg mannitol 20%) or hypertonic sodium (receiving 3 mg/kg hypertonic serum 5%).
Settings and conduct
This randomized clinical trial will be performed in 1400 at Sina Hospital in the neurosurgery room by the anesthesia department in collaboration with the neurosurgery department. Patients admitted to the study will be randomly divided into mannitol or hypertonic sodium during craniotomy to control cerebrospinal fluid.
Participants/Inclusion and exclusion criteria
Adult patients aged 18 to 65 years with ASA status I and II undergoing elective craniotomy. exclude criteria: previous history of cranial surgery, pregnancy, obesity (BMI above 40), sodium level> 160 ,Hb <10, treated patients With hyperosmotic fluids 24 hours before surgery.
Intervention groups
Patients enrolled in the study will be randomly divided into two groups: mannitol (receiving 5 ml/kg mannitol 20%) or hypertonic sodium (receiving 3 mg/kg hypertonic serum 5%).
Main outcome variables
systolic blood pressure, diastolic blood pressure, MAP, PPV pulse pressure changes, SVV stroke volume changes, cardiac output CO, cardiac index CI, SV stroke volume, systemic vascular resistance SVR ‌ will be registered. Oxygenation recorded during monitoring based on PaO2, PaCO2, HCO3, pH, SaO2

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170805035510N7
Registration date: 2022-01-20, 1400/10/30
Registration timing: prospective

Last update: 2022-01-20, 1400/10/30
Update count: 0
Registration date
2022-01-20, 1400/10/30
Registrant information
Name
Pejman Pourfakhr
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4466 3963
Email address
pourfakhr@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of mannitol and hypertonic sodium administration to reduce ICP on hemodynamic parameters under LiDCO monitoring in patients undergoing elective craniotomy
Public title
Comparison of the effect of mannitol and hypertonic sodium administration to reduce ICP on hemodynamic parameters
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA class 1,2 Elective Craniotomy
Exclusion criteria:
previous craniotomy pregnancy morbid obesity(BMI>40) Na>160 Hb<10 Patients treated with hyperosmotic fluids 24 hours before surgery
Age
From 18 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 22
Randomization (investigator's opinion)
Randomized
Randomization description
Using the website www.sealedenvelope.com/, quadruple blocks were generated for randomization. The number of generated blocks will be 12 (sample size 44). The website generates blocks randomly (taking into account the number of study groups They are equal in each block) then they are provided to the person as Excel output. The determination of entry to the study is done based on the blocks made in order to intervention or control groups based on generated blocks.
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
Ethics Committee of Tehran University of Medical Sciences and Health services
Street address
Tehran University of Medical Sciences, Central Building, Ghods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-04-26, 1400/02/06
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1400.016

Health conditions studied

1

Description of health condition studied
Craniotomy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pulse pressure variation
Timepoint
Every 20 min
Method of measurement
Advance Hemodynamic Monitoring

2

Description
Stroke volume variation
Timepoint
Every 20 min
Method of measurement
Advance Hemodynamic Monitoring

Secondary outcomes

1

Description
Acidosis
Timepoint
Every 1 hour
Method of measurement
Blood Gas Analysis

Intervention groups

1

Description
Intervention group: Receive 5 ml / kg mannitol 20% by slow intravenous injection after induction of anesthesia
Category
Treatment - Drugs

2

Description
Intervention group: Receive 3 mg / kg of hypertonic serum 5.% by slow intravenous injection after induction of anesthesia
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Pejman Pourfakhr
Street address
Sina hospital, Hasan abad Square.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
pourfakhr@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mohamad Ali Sahraian
Street address
Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Pejman Pourfakhr
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tehran University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
۱۱۳۶۷۴۶۹۱۱
Phone
+98 21 6312 1539
Fax
Email
pourfakhr@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pejman Pourfakhr
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tehran University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
۱۱۳۶۷۴۶۹۱۱
Phone
+98 21 6312 1539
Fax
Email
pourfakhr@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pejman Pourfakhr
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tehran University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
۱۱۳۶۷۴۶۹۱۱
Phone
+98 21 6312 1539
Fax
Email
pourfakhr@tums.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
Not applicable
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Laboratory information and monitoring device
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use of the data is subject to the permission of all beneficiaries of this trial
From where data/document is obtainable
Pejman Pourfakhr - Tehran, Imam Khomeini St., Sina Hospital, Anesthesia Department, Tel: 02163128
What processes are involved for a request to access data/document
At the request of the Vice Chancellor for Research, Department of Anesthesiology, Tehran University of Medical Sciences
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