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Comparing of recovery in total intravenous anesthesia(TIVA) with inhalation anaesthetic (sevoflurane) in children between 2-10 years old

Protocol summary

Study aim
Comparing of recovery in total intravenous anesthesia(TIVA) with inhalation anaesthetic (sevoflurane) in children
Design
Clinical trial with intervention groups, with parallel groups, double-blinded, randomized
Settings and conduct
In this double-blind randomized clinical trial, 80 patients from Tabriz children hospital with American society of Anesthesiologists (ASA) status I and II, undergoing elective outpatient operation under an hour(from March 2019 to August 2019) will be enrolled. The patients will be randomized in one of the two groups of total intravenous(T) and sevoflurane anesthesia.
Participants/Inclusion and exclusion criteria
inclusion criteria: children between 2-10 years old, Indicative Outpatient Surgery, Admitted to the Children's Hospital, Parental informed consent for the study, ASA class I and II Exclusion criteria:Sensitivity to any of the drugs used in the study, Children with underlying illnesses such as diabetes; asthma; congenital heart disease and ...
Intervention groups
Intervention group1:" Total Intravenous Anesthesia.received midazolam (0/03-0/05 mg/kg), Fentanyl 1µg/kg as a premedication. Anesthesia induction will be with Lidocaine 1mg / kg and propofol 3-5 mg / kg , Then LMA will be inserted with the right size. . Anesthesia maintenance with total Intravenous Anesthesia will be by infusion of propofol 100-200 mcg / kg and remifentanil 0.1 mcg / kg, 50% N2O, 50% O2 "Intervention group2:" Inhalation anesthesia with sevoflurane. received midazolam (0/03-0/05 mg/kg), Fentanyl 1µg/kg as a premedication. Anesthesia induction will be with Sevoflurane 8% , 50% N2O, 50% O2 .LMA will be inserted with the right size. Anesthesia maintenance will be by Sevoflurane inhalation 2-3% , 50% N2O, 50% O2
Main outcome variables
duration of stay in recovery, Blood pressure, Heart rate, pain, nausea

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190114042358N1
Registration date: 2019-02-25, 1397/12/06
Registration timing: registered_while_recruiting

Last update: 2019-02-25, 1397/12/06
Update count: 0
Registration date
2019-02-25, 1397/12/06
Registrant information
Name
Daryoush Sheikhzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3526 2257
Email address
dr.d.sheik@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing of recovery in total intravenous anesthesia(TIVA) with inhalation anaesthetic (sevoflurane) in children between 2-10 years old
Public title
Comparing of recovery in total intravenous anesthesia(TIVA) with inhalation anaesthetic (sevoflurane) in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
children between 2-10 years old Indicative Outpatient Surgery Admitted to the Children's Hospital Parental informed consent for the study ASA class I and II
Exclusion criteria:
Sensitivity to any of the drugs used in the study Children with underlying illnesses such as diabetes; asthma; congenital heart disease and ...
Age
From 2 years old to 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Random method: Block, Random unit: individual, Random Tool: Random Block 4. for this purpose, 25 blocks with 4 subjects in each block will be used. the combination of all patterns will be considered including AABB, ABAB, BABA, BBAA, BABA, BAAB. For selecting each blocks, dice drooped and the block number will be selected. this procedure continued to completed the allocation and reached to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blinded study and Researcher and patients are kept unaware of intervention in each group and In order to allocation concealment, the type of intervention will be written on paper and placed in numbered, matte and packed envelopes.The envelopes will be opened in the order of participation of the participants and the type of group will be determined.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Science , Gholghasht street , Azadi street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2019-01-13, 1397/10/23
Ethics committee reference number
IR.TBZMED.REC.1397.834

Health conditions studied

1

Description of health condition studied
inhalation anesthesia
ICD-10 code
Y48.0
ICD-10 code description
Inhaled anaesthetics

2

Description of health condition studied
Intravenous Anesthesia
ICD-10 code
Y48.1
ICD-10 code description
Parenteral anaesthetics

Primary outcomes

1

Description
Duration of stay in recovery
Timepoint
After entering till release from recovery
Method of measurement
According to Alderet Score

2

Description
Blood pressure
Timepoint
Every 5 minutes till release from recovery
Method of measurement
Monitor

3

Description
Heart rate
Timepoint
Every 5 minutes till release from recovery
Method of measurement
ECG device

4

Description
Nausea
Timepoint
After entering till release from recovery
Method of measurement
Visual Analogue Scale

5

Description
pain
Timepoint
After entering till release from recovery
Method of measurement
wong - baker pain scale

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group:" Total Intravenous Anesthesia.received midazolam (0/03-0/05 mg/kg), Fentanyl 1µg/kg as a premedication. Anesthesia induction will be with Lidocaine 1mg / kg and propofol 3-5 mg / kg , Then LMA will be inserted with the right size. Anesthesia maintenance with total Intravenous Anesthesia is done by infusion of propofol 100-200 mcg / kg and remifentanil 0.1 mcg / kg, 50% N2O, 50% O2
Category
Treatment - Drugs

2

Description
"Intervention group2:" Inhalation anesthesia with sevoflurane. received midazolam (0/03-0/05 mg/kg), Fentanyl 1µg/kg as a premedication. . Anesthesia induction will be with Sevoflurane 8% , 50% N2O, 50% O2 .LMA will be inserted with the right size. Anesthesia maintenance will be with Sevoflurane inhalation 2-3% , 50% N2O, 50% O2
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Children's Hospital
Full name of responsible person
Daryoush Sheikhzadeh
Street address
Tabriz Children's Hospital, Sheshgelan St
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Fax
+98 41 3526 2279
Email
dr.d.sheik@gmail.com
Web page address
https://childrenhospital.tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Tabriz University of Medical Sciences, Golghasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
ajouyban@hotmail.com
Web page address
https://www.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Daryoush Sheikhzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tabriz Children's Hospital, Sheshgelan St
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Fax
+98 41 3526 2278
Email
dr.d.sheik@gmail.com
Web page address
https://childrenhospital.tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Daryoush Sheikhzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tabriz Children's Hospital, Sheshgelan S
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Email
dr.d.sheik@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Razaghipour Sorkhab
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Tabriz University of Medical Science , Gholghasht street , Azadi street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3334 7054
Fax
+98 41 3526 2279
Email
Razagh92tabriz@yahoo.com

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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
A portion of the data that represents the final outcome
When the data will become available and for how long
Access will be 6 months after the results are printed.
To whom data/document is available
All Physicians and residents of the department of Anesthesia
Under which criteria data/document could be used
After obtaining permission from the deputy research of group
From where data/document is obtainable
Person responsible for scientific accountability of study
What processes are involved for a request to access data/document
First approved by the Research Vice-President
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