Evaluation of the effect of atracurium on the ease of hernia surgery in children
Design
This study is a randomized clinical trial with two parallel groups (intervention group 30 and control group 30). In this study, 60 patients with unilateral inguinal hernia with the inclusion criteria were randomly divided into intervention and control groups and each participant was assigned a code. Each group will receive its own intervention.
Settings and conduct
This study will be performed on children with a unilateral inguinal hernia. The study setting is Sheikh Hospital affiliated with Mashhad University of Medical Sciences. Patients with inclusion criteria are divided into two group using randomized assignment. In the intervention group, patients receive 0.3 mg/kg of atracurium, while the control group does not receive this intervention. In this double-blinded study, the investigator and patients are blinded.
Participants/Inclusion and exclusion criteria
All children (over 6 months and under 7 years of age) without underlying illness (collagen vasculature, altoegropenia), who undergo a selective surgical procedure for the repair of a one-sided and indirect hernia. Children with the previous history of sensitization to Atracurium will not be included in the study.
Intervention groups
In both groups, anesthetist, surgeon, and anesthetist are the same. In the intervention group, patients receive 0.3 mg / kg atracurium, while the control group does not receive this intervention. This drug is injected by a third person who is not aware of the study process.
Main outcome variables
The primary outcome is the surgeon's ease to see the hernial sac which is measured in three grades.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170829035978N1
Registration date:2018-01-19, 1396/10/29
Registration timing:registered_while_recruiting
Last update:2018-01-19, 1396/10/29
Update count:0
Registration date
2018-01-19, 1396/10/29
Registrant information
Name
Sahar Ahmadi Bonakdar
Name of organization / entity
MUMS
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5209
Email address
ahmadibs941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of atracurium on the ease of hernia surgery in children in compare with routine care
Public title
The effect of atracurium on the ease of hernial surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with a minimum of 6 months and a maximum of 7 years of age
Children with an inguinal hernia undergo elective surgery for a unilateral and indirect hernia
Children without underlying illness (collagen vasculature, altoprgenegna)
Exclusion criteria:
Having a history of allergy to atracurium
Renal Failure
Hepatic Failure
Age
From 6 months old to 7 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who met the inclusion criteria were randomly assigned to two groups of control and intervention using a random numbers table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are unaware of the type of intervention due to anesthesia.
The researcher was unaware of the allocation of the two intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Patients were assigned to the intervention and control group using random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad university of medical sciences
Street address
Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2016-08-05, 1395/05/15
Ethics committee reference number
IR.MUMS.fm.REC.1395.522
Health conditions studied
1
Description of health condition studied
Inguinal Hernia
ICD-10 code
K40
ICD-10 code description
Unilateral or unspecified inguinal hernia, without obstruction or gangrene
Primary outcomes
1
Description
The ease of the surgeon in seeing the hernia sac
Timepoint
post intervention
Method of measurement
Grading the surgeon satisfaction by researcher constracted scale based on three grades: (1) Easily accessible and found with the first attempt. (2) The hernia sack is not easily found and two or three attempts to find the sack are necessary (3) The sack is hard to find and gets torn when the sack is found.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Injection of Atracurium 0.3 mg/kg simultaneously with induction of anesthesia.
Category
Treatment - Drugs
2
Description
Control group: Routine intervention that is performed during all children's inguinal hernia surgery. The injection of atracurium is not routinely used in these surgeries.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Sheikh Hospital
Full name of responsible person
Sahar Ahmadi Bonakdar
Street address
Tohid Square, Taheri St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3859 1513
Email
ahmadibs941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vice chancellor for research
Street address
Fakory Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699563
Phone
+98 51 3841 3007
Email
ahmadibs941@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad university of medical sciences
Full name of responsible person
Sahar Ahmadi
Position
MD
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Fakory street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3852 5209
Email
ahmadibs941@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammad Gharavifard
Position
MD
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Faculty of Medicine, Ferdowsi University, Bahonar St., Vakil Abad Ave.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3882 8888
Fax
+98 51 3852 5209
Email
gharavifard@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of medical sciences
Full name of responsible person
Sahar Ahmadi Bonakdar
Position
M.D
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Shahid Fakori Blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3852 5209
Email
sahaboakadar65@yahoo.com
Web page address
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available