Determination of the effect of using propofol in anesthesia on the level of lipid and bicarbonate ion in patients undergoing spinal surgery
Design
This semi-experimental clinical trial will be conducted in a group of 58 people as a comparison before and after the intervention in one group. The study was not blinded and the sampling was non-probable and accessible.
Settings and conduct
This study will be conducted in the operating room of Allameh Bahloul Gonabadi Hospital on candidates for spine surgery under anesthesia with propofol to measure the effect of propofol on blood characteristics of patients during surgery. Before anesthesia, blood samples will be taken from the patients, and then all patients will be under anesthesia with propofol, and 4 hours after anesthesia, blood samples will be taken again.
The results obtained from the studied variables in the sample obtained before and after anesthesia will be compared with each other. The patients and the main researcher of the study were not blinded, but blinding will be done by the person analyzing. So that the data of the study is collected in two groups A and B by the researcher and during the analysis, the person analyzing will not know how to allocate the data in the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Age 20 to 70 years
ASA class I and II
Without underlying liver and blood disease
No addiction
No overweight
Exclusion criteria:
Lack of informed consent
Occurrence of heart and blood problems before surgery
Intervention groups
The intervention group includes patients who are candidates for spine surgery under propofol anesthesia.
Main outcome variables
blood pH, bicarbonate ion, and lipid levels(LDL, HDL, triglycerides, cholesterol)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200501047254N3
Registration date:2024-03-02, 1402/12/12
Registration timing:registered_while_recruiting
Last update:2024-03-02, 1402/12/12
Update count:0
Registration date
2024-03-02, 1402/12/12
Registrant information
Name
Fatemeh Pouladkhay
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3360
Email address
pouladkhay.fatemeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining the effect of using the drug propofol in anesthesia on the blood fat and bicarbonate ion levels in patients undergoing spinal surgery
Public title
Effect of Propofol Drug on Lipid Level and Blood PH
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent of the patient to participate in the research
Patient age between 20 and 70 years
Patient with ASA class I and II
Duration of surgery at least 4 hours
Blood fat before the operation should be at a normal level (less than 200).
Blood pH should be at a normal level before the operation.
Do not have underlying diseases including liver and blood diseases.
The patient should not be a candidate for surgery due to trauma and in emergency conditions.
The patient does not have a history of drug addiction.
The patient should not be overweight or obese.
The patient does not have a history of taking antipsychotic drugs
Exclusion criteria:
Patient withdrawal from participating in research
Occurrence of heart and respiratory problems before the start of the plan
Age
From 20 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
58
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding is done in one blind way so that the study data is collected in two groups A and B by the researcher and during the analysis, the person analyzing will not know how the data is allocated in the two groups.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Ghadir Square, Imam Khomeini Street, Gonabad Medical Sciences Headquarters
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2024-02-07, 1402/11/18
Ethics committee reference number
Ir.gmu.rec.1402.152
Health conditions studied
1
Description of health condition studied
Spine surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Blood triglyceride levels
Timepoint
Before starting NPO, 4 hours after surgery
Method of measurement
Triglyceride test product of Dialab company
Secondary outcomes
1
Description
Blood PH level
Timepoint
Before starting fasting, 4 hours after surgery
Method of measurement
ABG Test
2
Description
Blood bicarbonate ion level
Timepoint
Before starting fasting, 4 hours after surgery
Method of measurement
ABG Test
3
Description
HDL Level
Timepoint
Before starting NPO, 4 hours after surgery
Method of measurement
HDL test product of Dialab company
4
Description
LDL Level
Timepoint
Before starting NPO, 4 hours after surgery
Method of measurement
LDL test product of Bionic company
5
Description
Cholesterol Level
Timepoint
Before starting NPO, 4 hours after surgery
Method of measurement
Cholesterol test product of Dialab company
Intervention groups
1
Description
Intervention group: This group will include patients who are candidates for spine surgery under anesthesia with propofol at a dose of 10 mg/kg/hour Product of B-Broun, Germany that they have been under anesthesia with propofol for at least 4 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Allameh Bahloul Gonabadi Hospital
Full name of responsible person
Mohammad Taghi Khodadadi
Street address
Nurse Blvd., Saadi St., Allameh Bahloul Gonabadi Hospital
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5723 6833
Fax
+98 51 5723 6160
Email
pouladkhay.fatemeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mohammad Taghi Khodadadi
Street address
Nurse Blvd., Saadi St., Allameh Bahloul Gonabadi Hospital
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5723 6833
Email
dr_khodadadi_m@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Mohammad Taghi Khodadadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Nurse Blvd., Saadi St., Allameh Bahloul Gonabadi Hospital
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5723 6833
Email
dr_khodadadi_m@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mohammad Taghi Khodadadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Nurse Blvd., Saadi St., Allameh Bahloul Gonabadi Hospital
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5723 6833
Email
dr_khodadadi_m@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Pouladkhay
Position
Faculty member instructor
Latest degree
Master
Other areas of specialty/work
operation room
Street address
On the side of Asian Road, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3360
Fax
Email
pouladkhay.fatemeh@gmail.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
Not applicable
Informed Consent Form
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
When the data will become available and for how long
.
To whom data/document is available
.
Under which criteria data/document could be used
.
From where data/document is obtainable
.
What processes are involved for a request to access data/document