Evaluation of effect of atropine administration before induction of anesthesia on the incidence of delirium and complications in post-anesthesia care unit among children aged 1-6 years old undergoing lower abdominal surgery as compared with the control group
Determining and comparing the effect of atropine administration before induction of anesthesia on the incidence of delirium and complications in post-anesthesia care unit among children aged 1-6 years old undergoing lower abdominal surgery as compared with the control group
Design
A randomized, double-blinding clinical trial, with the parallel groups, Phase 2-3 on 70 patients
Settings and conduct
In this randomized double-blind randomized clinical trial study, 70 children who are candidates for lower abdominal surgery presented at Imam Hossein Hospital in Isfahan will be included in the study and will be randomly divided into 2 groups. One group will receive atropine and the other group will receive a placebo before induction of anesthesia. Delirium score, pain score, and hemodynamic parameters of patients will be evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age group of 1 to 6 years old; candidate for lower abdominal surgery; class I and II classification of the American Society of Anesthesiologists, and parental consent to participate in the study. Exclusion criteria: having a child with a psychiatric problem including ADHD and depression, and other behavioral disorders.
Intervention groups
Intervention group 1: patients in this group receive 0.02 mg/kg of atropine before induction of anesthesia (after dilution with a volume of 0.1 mg per cc). Control group: patients in this group receive 0.02 mg/kg of normal saline (with the same volume in the first group) before induction of anesthesia.
Main outcome variables
Delirium; pain; blood pressure; heart rate; percentage of oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N33
Registration date:2021-05-13, 1400/02/23
Registration timing:prospective
Last update:2021-05-13, 1400/02/23
Update count:0
Registration date
2021-05-13, 1400/02/23
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of atropine administration before induction of anesthesia on the incidence of delirium and complications in post-anesthesia care unit among children aged 1-6 years old undergoing lower abdominal surgery as compared with the control group
Public title
Effect of atropine administration before induction of anesthesia on the incidence of delirium and complications in post-anesthesia care unit among children aged 1-6 years old undergoing lower abdominal surgery as compared with the control group
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age category 1 to 6 years old
Candidate for lower abdominal surgery
Class I and II classification of the American Society of Anesthesiologists
Parents' consent to participate in the study
Exclusion criteria:
Having a child with a psychiatric problem, including ADHD and depression and other behavioral disorders
Age
From 1 year old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 70 eligible patients will be randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the two study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, Placebo and Atropine, are prepared by the pharmacist and placed in coded packages and delivered daily to an anesthesiologist, who prescribes them without knowing the type of each drug. Also, the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention.
Placebo
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., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2017-05-26, 1396/03/05
Ethics committee reference number
IR.MUI.REC.1396.3.855
Health conditions studied
1
Description of health condition studied
Lower abdomen surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Delirium score
Timepoint
Immediately upon entering the recovery ward and 15, 30 and 45 minutes later in the recovery
Behavioral scale derived from the Face, Leg, Activity, Cry, Consolability (FLACC)
3
Description
Blood Pressure
Timepoint
Immediately after surgery, in the minutes of 15, 30, and 45 during surgery and immediately, 15, 30, and 45 minutes after recovery
Method of measurement
Monitoring device
4
Description
Heart rate
Timepoint
Immediately after surgery, in the minutes of 15, 30, and 45 during surgery and immediately, 15, 30, and 45 minutes after recovery
Method of measurement
Monitoring device
5
Description
Percentage of oxygen saturation
Timepoint
Immediately after surgery, in the minutes of 15, 30, and 45 during surgery and immediately, 15, 30, and 45 minutes after recovery
Method of measurement
Monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: patients in this group receive 0.02 mg/kg of atropine before induction of anesthesia (after dilution with a volume of 0.1 mg per cc).
Category
Treatment - Drugs
2
Description
Control group: patients in this group receive 0.02 mg/kg of normal saline (with the same volume in the first group) before induction of anesthesia.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital in Isfahan
Full name of responsible person
Amir Shafa
Street address
Imam Khomeini street
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
shafa_amir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Amir Shafa
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology; Al-Zahra Hospital; Sofeh boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
shafa_amir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology; Al-Zahra Hospital; Sofeh boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
shafa_amir@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology; Al-Zahra Hospital; Sofeh boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
shafa_amir@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD