Comparative evaluation between two methods of maintenance of anesthesia : Inhalational anesthesia and Propofol anesthesia on average blood loss and vital sign changes during cesarean delivery in patients with placenta invasion
Comparison between two methods of maintenance of anesthesia : Inhalational anesthesia and Propofol anesthesia on average blood loss and vital sign changes during cesarean delivery in patients with placenta invasion
Design
Two arm parallel group randomised clinical trial with blinded patients and data analyzer.
Settings and conduct
This study will be performed in the years 2020_2021 on patients with placental adhesion who are candidates for cesarean section in the hospitals of Isfahan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients diagnosed with placenta invasion
Candidate for cesarean section in hospitals of Isfahan University of Medical Sciences
No contraindication for general anesthesia
Written informed consent
Exclusion criteria:
Confirmed coagulation disorder
Confirmed cardiac disorder
Percreta placental adhesion if diagnosed before surgery
Egg allergy
Recent anesthesia with inhaled anesthetics
Intervention groups
Inhalational anesthesia and Propofol anesthesia
Main outcome variables
Blood loss volume; Units of transfused blood products; Heart rate; Systolic blood pressure; Diastolic blood pressure; Mean arterial blood pressure; Respiratory rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110213005825N3
Registration date:2020-12-09, 1399/09/19
Registration timing:prospective
Last update:2020-12-09, 1399/09/19
Update count:0
Registration date
2020-12-09, 1399/09/19
Registrant information
Name
Parvin Sajedi
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan, I
Country
Iran (Islamic Republic of)
Phone
+98 31 1776 9721
Email address
sajedi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation between two methods of maintenance of anesthesia : Inhalational anesthesia and Propofol anesthesia on average blood loss and vital sign changes during cesarean delivery in patients with placenta invasion
Public title
Comparative evaluation between two methods of maintenance of anesthesia : Inhalational anesthesia and Propofol anesthesia on average blood loss and vital sign changes during cesarean delivery in patients with placenta invasion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with placenta invasion
Candidate for cesarean section in hospitals of Isfahan University of Medical Sciences
No contraindication for general anesthesia
Written informed consent
Exclusion criteria:
Confirmed coagulation disorder
Confirmed cardiac disorder
Percreta placental adhesion if diagnosed before surgery
Egg allergy
Recent anesthesia with inhaled anesthetics
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomized / Personal / SPSS statistical software / Random Allocation
38 people are selected for each of the two groups and participants are assigned by SPSS software and random allocation between the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind: patient and data Analyzer
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-11-13, 1399/08/23
Ethics committee reference number
IR.MUI.MED.REC.1399.711
Health conditions studied
1
Description of health condition studied
Placenta invasion
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Blood loss volume
Timepoint
After cesarean section
Method of measurement
Total volume of suction and gases used
2
Description
Units of transfused blood products
Timepoint
After cesarean section
Method of measurement
Patient file
3
Description
Heart rate
Timepoint
Every 15 minutes from the beginning of anesthesia until discharging from recovery
Method of measurement
Monitoring system
4
Description
Systolic blood pressure
Timepoint
Every 15 minutes from the beginning of anesthesia until discharging from recovery
Method of measurement
Monitoring system
5
Description
Diastolic blood pressure
Timepoint
Every 15 minutes from the beginning of anesthesia until discharging from recovery
Method of measurement
Monitoring system
6
Description
Mean arterial blood pressure
Timepoint
Every 15 minutes from the beginning of anesthesia until discharging from recovery
Method of measurement
Calculation
7
Description
Respiratory rate
Timepoint
Every 15 minutes from the beginning of anesthesia until discharging from recovery
Method of measurement
Monitoring system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Propofol anesthesia. In this group, patients are anesthetized with propofol, the induction dose is 2 mg / kg by bolus injection and the maintenance dose is 0.1 to 0.2 mg / kg by infusion.
Category
Treatment - Drugs
2
Description
Control group: Inhalational anesthesia. In this group, patients are anesthetized with isoflurane. Anesthesia is induced with sodium thiopental and maintenance is performed by 1.2 MAC isoflurane by infusion.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Arman Emami
Street address
Alzahra hospital, soffe Blvd, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh haghjoo
Street address
Hezar Jerib street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
international@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Parvin Sajedi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1776 9721
Fax
Email
sajedi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parvin Sajedi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1776 9721
Fax
Email
sajedi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parvin Sajedi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1776 9721
Fax
Email
sajedi@med.mui.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
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