Protocol summary

Study aim
Comparison of TIVA and Sevoflurane on changing the results of Pulmonary Function Test (PFT) in patients undergoing inguinal hernia surgery
Design
In this interventional study, 18-65 year old patients, with ASA class 1 and 2 who undergo inguinal herniation surgery in the supine position, randomly assign to into two groups consisted of 55 people. Randomization will be done through using permutated blocks.
Settings and conduct
During this practical interventional study, patients who meet inclusion criteria will randomly dividing into two 55-member groups. Before starting anesthesia, both groups undergoing spirometry at Kashan Naghavi Hospital and then under the same conditions, they will be under anesthesia induction and monitoring . Then with single-blind way, one group will be undergoing propofol infusion and the second one ,will get anesthesia with sevoflurane. Finally, after being aware completely , patients will perform the spirometry test again in the recovery room and the recorded results will be analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with ASA class 1 & 2, aged 18 to 65 years old, Candidate for unilateral inguinal hernia surgery. Exclusion criteria: severe cardiovascular diseases, the patient with COPD, chest deformity, liver and kidney failure, and BMI more than 35.
Intervention groups
In this study,The subjects of each group,will recieve general anesthesia induction at the same condition, and then ,they will be devided into two groups of 55 members.In the first group those pateint recieving intravenous anesthesia( TIVA), will be infused by propofol and in the second group,anesthesia will be maintained with sevoflorane and N2O until the end of the operation.
Main outcome variables
Forced Vital Capacity (FVC); Forced Expiratory Volum in First second(FEV1); FEV1 / FVC.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180108038263N1
Registration date: 2018-05-29, 1397/03/08
Registration timing: retrospective

Last update: 2018-05-29, 1397/03/08
Update count: 0
Registration date
2018-05-29, 1397/03/08
Registrant information
Name
Leila Mehrzad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
mehrzad-l@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of The Effects of Sevoflurane and Itotal ntravenous Anaesthesia (TIVA) on Pulmonary Function Tests(PFT)
Public title
Comparison of The Effects of Sevoflurane and Total Intravenous Anaesthesia on postoperative Pulmonary Function Tests
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with American Society Anesthesia (ASA) grade 1 & 2, Being at the age of 18 to 65 years old, candidate for unilateral inguinal hernia surgery.
Exclusion criteria:
Patients with severe cardiovascular disease Patients with Chronic Obstructive Pulmonary Diseases(COPD) Patients with chest deformity Patients with kidney and liver failure Patients with Body Mass Index(BMI) greater than 35
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 110
More than 1 sample in each individual
Number of samples in each individual: 2
Before and after operation, spirometry is performed for each patient.
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted blocked randomization,sampling in each group is based on quadruple blocks obtained from random codes extracted from random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
Study is single blind, After entering the study, patients are randomized to either Sevoflurane or Propofol group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Pezeshk Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2017-10-19, 1396/07/27
Ethics committee reference number
IR.kaums.mednt.rec1396066

Health conditions studied

1

Description of health condition studied
lung function tests
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Forced Expiratory Volum (FEV1)
Timepoint
Prior the onset of anesthesia, after the operation in recovery room
Method of measurement
Spirometer

2

Description
Forced Vital Capacity (FVC)
Timepoint
Prior the onset of anesthesia, after the operation in recovery room
Method of measurement
Spirometer

3

Description
FEV1/FVC
Timepoint
Prior the onset of anesthesia, after the operation in recovery room
Method of measurement
Spirometer

Secondary outcomes

empty

Intervention groups

1

Description
First Intervention group: with Conventional Anesthesia Method the anesthesia will be administered by following drugs, including Midazolam 2 Milligram( mg) Intravenous (IV),Fentanyl 2 microgram per Kilogram(µ/kg), Propofol 2/5 milligram per kilogram(mg/kg) IV, Atracurium 0.5 mg/kg IV, and anesthesia will be maintained with 1-1.5 Minimum Alveolar Concentration( Mac) sevoflurane and Nitric Oxide (N2O) 70% and Oxygen (O2) 30%.each Mac of Sevofloran is 3%
Category
Treatment - Drugs

2

Description
Second Intervention group: with Conventional Anesthesia Method, anesthesia will be administered by following drugs, including Midazolam 2 mg IV, Fentanyl 2 µ/kg, Propofol 2/5 mg/kg IV, Atracurium 0.5 mg/kg IV, and anesthesia will be maintained with infusion of 100 ug/kg/min propofol.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Naghavi hospital
Full name of responsible person
Leila Mehrzad
Street address
ُShahid Rajaee Street
City
Kashan
Province
Isfehan
Postal code
8713743444
Phone
+98 31 5545 1580
Email
mehrzad-l@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Vice chancellor for research, Medical School, 5th km of Ghotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Fax
+98 31 5557 5057
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Leila Mehrzad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Beheshti hospital, 5th km of Ghotbe Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8766153781
Phone
+98 314346844
Email
Mehrzad-l@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hajijaafari Mohammad Ali
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shaheed Beheshti Hospital, Parastar Blvd
City
Kashan
Province
Isfehan
Postal code
8766153781
Phone
+98 315550026
Email
Dr_hajijafari@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Leila Mehrzad
Position
Resident in training
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shaheed Beheshti Hospital, Parastar Blvd.
City
Kashan
Province
Isfehan
Postal code
8766153781
Phone
+98 31 5554 0026
Fax
Email
mehrzad-l@kaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only the details of the original outcome are shared.
When the data will become available and for how long
Immediately after printing the results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Any statistical analysis on data is allowed.
From where data/document is obtainable
To accsess the data,people should send name,degree of education,and intended university to this email adress:l.mehrzad.20002gmail.com
What processes are involved for a request to access data/document
To accsess the data,people should send name,degree of education,and intended university to this email adress:l.mehrzad.20002gmail.com
Comments
Loading...