The aim of this study was to measure the serum levels of cytokines including interleukin 6, interleukin 10 and TNFα in general and spinal anesthesia and compare them with each other in cesarean section.
Design
Clinical trial, with a parallel group design, with blinded outcome assessment, randomized using random number table, performs on 30 patients between April 2020 and March 2021.
Settings and conduct
30 patients undergoing cesarean section who refer to Taleghani Hospital are randomly assigned into two similar groups of 15 people of spinal anesthesia and general anesthesia. In the spinal anesthesia group, 2.8 cc of 0.5% Marcaine is injected into the L3-L4 or L4-L5 space. In the general anesthesia group, endotracheal intubation is performed with thiopental 4-6 mg / kg and succinylcholine 1-1.5 mg / kg . It is then continued with nitrous oxide 50 % and 0.8% isoflurane. After delivery of baby, fentanyl 200µgr per 70 kg is injected. Both groups are given two diclofenac suppositories of 100 mg after anesthesia to control postoperative pain.
Participants/Inclusion and exclusion criteria
All patients scheduled for cesarean section, who have completed the consent form and are ASA Class I, II, are included in the study. Patients with coagulation disorders and phospholipid syndrome are excluded from the study.
Intervention groups
Two groups of general and spinal anesthesia .
Main outcome variables
Interlukin-6؛ Interlukin10؛ TNFα
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200930048887N1
Registration date:2020-10-13, 1399/07/22
Registration timing:registered_while_recruiting
Last update:2020-10-13, 1399/07/22
Update count:0
Registration date
2020-10-13, 1399/07/22
Registrant information
Name
Maryam Vosoughian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2595
Email address
maryam.vosoghian@mail.sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of general anesthesia and spinal anesthesia on serum cytokines in cesarean section patients
Public title
The effect of type of anesthesia method on serum cytokines in cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients refer to Taleghani Hospital for cesarean section
Patients who fill out the consent form
ASA Class I, II patients
Exclusion criteria:
Patients with any coagulation disorder
Patients with antiphospholipid syndrome
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly divided into study groups 1 or 2 using a random number table. The names of the assigned group are written on the cards and placed in numbered and sealed envelopes. When each eligible woman enters the study, a numbered envelope is opened in sequence and the group is assigned.
Blinding (investigator's opinion)
Single blinded
Blinding description
A person who is not involved in the study opens the numbered envelope in sequence. Laboratory staff and data analysts are also unaware of the assignment of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Measurement of cytokines before cesarean section and half an hour after recovery
Method of measurement
ELIZA method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:. In spinal anesthesia group, 2.8 cc of 0.5% Marcaine(Bupivacaine MYLAM SANT PRIEST-FRANCE) is injected into the L3-L4 or L4-L5 space.
Category
Treatment - Other
2
Description
Intervention group: . In the general anesthesia group, rapid sequence induction by thiopental 4-6 mg / kg and succinylcholine 1-1.5 mg / kg and endotracheal intubation is performed . Then oxygen and nitrous oxide 50% and 0.8% isoflurane is continued . After delivery of baby, fentanyl 200µgr per 70 kg is injected.