Comparison of the outcomes of inhaled anesthesia in children undergoing inguinal hernia repair surgery under general anesthesia
Design
A Single-blind, randomized- controlled clinical trial study with parallel groups and phases 3 on 70 patients. Randomization will be done based on block randomization using Random allocation software.
Settings and conduct
In this study, children undergoing inguinal hernia repair surgery in Urmia Motahari Hospital will be included. This study will be a single blind study and the patient will be blind about allocation in the intervention or control group.
Participants/Inclusion and exclusion criteria
In this study, 70 children of 2 to 6 years who are candidates for inguinal hernia repair surgery under general anesthesia will be included. Emergency surgeries,
Surgeries longer than an hour, children with an active disease in the respiratory system, A history of sleep apnea, fever-induced seizures, developmental disorders and cardiac disorders will be excluded.
Intervention groups
In the intervention group, inhalation anesthesia will be induced with 8% sevoflurane and oxygen and nitrous oxide before peripheral intravenous insertion. In the control group, peripheral intravenous insertion will be performed without induction of inhalation anesthesia and when the patient is awake. In both groups, anesthesia induction will be performed after peripheral intravenous insertion with propofol 3-5 mg / kg and lidocaine 1 mg / kg and then airway management will be done with laryngeal mask airway (LMA) according to the weight of the child.
Main outcome variables
Frequency and severity of agitation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170516033992N9
Registration date:2022-02-20, 1400/12/01
Registration timing:prospective
Last update:2022-02-20, 1400/12/01
Update count:0
Registration date
2022-02-20, 1400/12/01
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3222 2010
Email address
karami.t@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the outcomes of inhaled anesthesia in children undergoing inguinal hernia repair surgery under general anesthesia
Public title
Inhaled anesthesia in children undergoing inguinal hernia repair surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 2 to 6 years
Children undergoing inguinal hernia repair surgery
Exclusion criteria:
Emergency surgeries
Surgeries longer than an hour
The presence of active disease in the respiratory system
A history of sleep apnea
Fever-induced seizures
Developmental Disorders
Cardiac disorders
Age
From 2 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention and control groups using block randomization based on generated numbers by Random allocation software. Thus, in this software, first the number of groups and the total number of the sample size will be entered, and then in the block section, the Block randomization method will be selected. Patients will be allocated in intervention or control groups based on generated numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be conducted as single blind clinical trial study. The patient will be blind that inhalation anesthesia will be induced before peripheral venous route insertion or not.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat street, Jahad Blvd., Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2021-11-10, 1400/08/19
Ethics committee reference number
IR.UMSU.REC.1400.346
Health conditions studied
1
Description of health condition studied
Inguinal hernia repair
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
Agitation
Timepoint
Every 10 minutes to 30 minutes after surgery
Method of measurement
Confusion or disturbance in the patient's awareness to the place and time
2
Description
Agitation severity
Timepoint
Every 10 minutes to 30 minutes after surgery
Method of measurement
Scores based on Pediatric Anesthesia Emergence Delirium(PAED) Scale
Secondary outcomes
1
Description
Nausea and vomiting
Timepoint
Every 10 minutes to 30 minutes after surgery
Method of measurement
clinical examination
2
Description
Time to wake up
Timepoint
Duration until waking up
Method of measurement
Minutes
Intervention groups
1
Description
Intervention group: inhalation anesthesia will be induced with 8% sevoflurane and oxygen and nitrous oxide before peripheral intravenous insertion. In addition routine anesthesia induction will be performed after peripheral intravenous insertion with propofol 3-5 mg / kg and lidocaine 1 mg / kg and then airway management will be done with laryngeal mask airway (LMA) according to the weight of the child.
Category
Treatment - Other
2
Description
Control group: peripheral intravenous insertion will be performed without induction of inhalation anesthesia and when the patient is awake. In addition routine anesthesia induction will be performed after peripheral intravenous insertion with propofol 3-5 mg / kg and lidocaine 1 mg / kg and then airway management will be done with laryngeal mask airway (LMA) according to the weight of the child.