Comparison of the effect of general and spinal anesthesia on serum level of pro-inflammatory and anti-inflammatory factors after abdominal hysterectomy surgery: a non-randomized clinical trial
Determining the level of inflammatory, and anti-inflammatory in hysterectomy patients using general and spinal anesthesia.
Design
A non-randomized, single-blind, parallel-group, two-arm clinical trial (21 patients in each group).
Settings and conduct
The study will be a non-randomized, single-blind clinical trial at Afzalipur Hospital in Kerman. According to the medical considerations and the individual's desire, if it is clinically possible, the patients were placed in one of the study groups to receive spinal or general anesthesia before hysterectomy surgery. The principal investigator and data analyst were masked from patient allocation.
Participants/Inclusion and exclusion criteria
Patients who will undergo hysterectomy with different diagnoses are included in the study. Patients with a history of inflammatory and autoimmune disease, endocrine disorders, severe neurological disease, use of corticosteroids in the three months before surgery, or evidence of any infectious disease are excluded from the study.
Intervention groups
Patients in the intervention group received spinal anesthesia (20 µg Fentanyl, 20 µg Bupivacaine, and 10 µg Epinephrine) and patients in the control group received general anesthesia (0.01 mg of midazolam, 3 µg Fentanyl, and 5 mg/weight of Thiopental and 0.5 mg/weight of Atracurium) before operation.
Main outcome variables
serum level of inflammatory factors IL-2; IL 17; IL 6; TNF α
serum level of non-inflammatory factors IL-10
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190819044559N4
Registration date:2023-01-31, 1401/11/11
Registration timing:registered_while_recruiting
Last update:2023-01-31, 1401/11/11
Update count:0
Registration date
2023-01-31, 1401/11/11
Registrant information
Name
Morteza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3223 5011
Email address
mortezahashemian@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of general and spinal anesthesia on serum level of pro-inflammatory and anti-inflammatory factors after abdominal hysterectomy surgery: a non-randomized clinical trial
Public title
The effect of general and spinal anesthesia on the level of inflammatory factors in hysterectomy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who will undergo hysterectomy with different diagnoses are included in the study.
Exclusion criteria:
Patients with a history of any type of inflammatory and autoimmune disease
History of endocrine diseases
Severe neurological disease
Corticosteroid use in the three months before surgery
Evidence of any infectious disease
Age
From 35 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will be single-blinded. The outcome assessor and data analyst and researcher who must enter the data into the relevant checklist will be blinded to the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Afzalipour Hospital- Kerman University of Medical Sciences
Street address
Close to Shahid Bahonar University, Imam Khomeyni highwey,
City
Kerman
Province
Kerman
Postal code
7616913911
Approval date
2022-10-18, 1401/07/26
Ethics committee reference number
IR.KMU.AH.REC.1401.154
Health conditions studied
1
Description of health condition studied
Inflammatory factors after hysterectomy
ICD-10 code
N93.9
ICD-10 code description
Abnormal uterine and vaginal bleeding, unspecified
Primary outcomes
1
Description
IL -17 serum level
Timepoint
Before intervention, 48 hours after intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA)
2
Description
IL-2 serum level
Timepoint
Before intervention, 48 hours after intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA)
3
Description
IL -6 serum level
Timepoint
Before intervention, 48 hours after intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA)
4
Description
TNF -α serum level
Timepoint
Before intervention, 48 hours after intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA)
5
Description
IL-10 serum level
Timepoint
Before intervention, 48 hours after intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients receive spinal anesthesia (20 micrograms of fentanyl, 20 micrograms of bupivacaine and 10 micrograms of epinephrine).
Category
Treatment - Surgery
2
Description
Control group: Patients will receive general anesthesia (0.01 mg midazolam, 3 μg fentanyl, 5 mg/wt thiopental, and 0.5 mg/wt atracurium) before the procedure.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Morteza hashemian
Street address
Close to Shahid Bahonar University, Imam Khomeyni highwey
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
mortezahashemain@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpouafshar
Street address
Ebn-e Sina st, Jahad blvd.
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
VCR@KMU.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Morteza Hashemian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Bahonar hospital, Gharani st.
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3223 5011
Fax
Email
mortezahashemian@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ladan Amirkhosravi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Close to Shahid Bahonar University, Imam Khomeyni highwey
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
l.amirkhosravi@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ladan Amirkhosravi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Close to Shahid Bahonar University, Imam Khomeyni highwey.
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
l.amirkhosravi@kmu.ac.ir
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 further information
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
No - There is not 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