Comparison of the effect of dexmedetomidine and atracurium in the ease of the tracheal after induction with propofol and sufentanil in children aged 6 to 12 years without neuromuscular relaxants
In this study, due to the limited studies that have been done in this field, we want to compare the rapid infusion of dexmedetomidine at the rate of 1 μg / kg with atracurium in improving the consequences of intubation without affecting hemodynamics in children after intubation with propofol and fentanyl. Let's pay
Design
a community-based, parallel-group, double-blind, randomized controlled trial, controlled clinical trial with a parallel-group design of 50 patients, randomized based on a random table of numbers.
Settings and conduct
The present study will be a prospective double-blind clinical trial in which fifty patients aged 6 to 12 years in the teaching hospitals of Mashhad University of Medical Sciences who are candidates for tracheal intubation under general anesthesia are available by sampling method.
Participants/Inclusion and exclusion criteria
Age between six to twelve years
Candidates for tracheal intubation under general anesthesia who are candidates for elective surgery
Asa physical condition score one and two
Consent of the patient's guardian or legal guardian to enter the study
Intervention groups
Intervention group: Use of dexmedetomidine in combination with sufentanil and propofol
Control group: Use of Atracurium in combination with sufentanil and propofol
Main outcome variables
Primary outcome: Success rate in intubation
Secondary Outcome: Secondary Outcomes Including Hemodynamic Responses at Zero Time: Before Induction Time 1 After Induction and Before Intubation and Time Two One Minute After Intubation Measured in two groups and the incidence of complications in both groups and status scoring Intubation (scoring)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201028049177N1
Registration date:2021-05-24, 1400/03/03
Registration timing:retrospective
Last update:2021-05-24, 1400/03/03
Update count:0
Registration date
2021-05-24, 1400/03/03
Registrant information
Name
Samira Ghanei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3611 2385
Email address
ghaneisamira@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-19, 1397/12/28
Expected recruitment end date
2021-03-18, 1399/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of dexmedetomidine and atracurium in the ease of the tracheal after induction with propofol and sufentanil in children aged 6 to 12 years without neuromuscular relaxants
Public title
Comparison of the effect of dexmedetomidine and atracurium in the ease of the tracheal after induction with propofol and sufentanil in children aged 6 to 12 years without neuromuscular relaxants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between six to twelve years
Candidates for tracheal intubation under general anesthesia who are candidates for elective surgery
Asa physical condition score one and two
Consent of the patient's guardian or legal guardian to enter the study
Exclusion criteria:
Respiratory tract infection three weeks before intubation
Children with cardiovascular disease
Children have a difficult airway for intubation
Children with morbid obesity (weight to height ratio more than 20%)
Children with neuromuscular diseases
Dissatisfaction of parents or legal guardians of patients to enter the study
Age
From 6 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly assigned into two groups of 25 patients with categories of 2 using the randomization method. A noninvolved researcher will determine the random assignment sequencing in sampling using a statistical analysis system (SAS), computer software. Sealed opaque envelopes will be used to conceal the sequencing. Accordingly, the participants were given codes and assigned into the 2 intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and intubation technicians were initially informed of the study process and its contents, but were unaware that participants were in the intervention or control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of medical Sciences
Street address
Razavi Khorasan Province, Mashhad, Ahmadabad Blvd, Department of Anesthesia and critical care, Dr. Mohammad Alipor
City
mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Approval date
2019-06-18, 1398/03/28
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.381
Health conditions studied
1
Description of health condition studied
Comparison of the effect of dexmedetomidine and atracurium in the ease of the tracheal after induction with propofol and sufentanil in children aged 6 to 12 years without neuromuscular relaxants
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation
Primary outcomes
1
Description
success rate in intubation
Timepoint
before intervention and 1 min after intervention
Method of measurement
Ease of intubation based on scoring table and intubation anesthesia partner checklist. Vital signs were recorded by monitoring. Includes sphygmomanometer .Pulse oximetry .Electrocardiogram
2
Description
Success rate in intubation in two groups/Hemodynamic responses
Timepoint
At zero time: before induction time one after induction and before intubation and time two one minute after intubation
Method of measurement
Scoring table / monitoring of blood pressure, heart rate and pulse oximetry
Secondary outcomes
1
Description
Secondary outcomes include hemodynamic responses at time zero: before induction, time one after induction and before intubation, and two minutes one minute after intubation measured in both groups and the incidence of complications in both groups and scoring the intubation status (scoring)
Timepoint
before intervention and 1 min after intervention
Method of measurement
the scoring method
Intervention groups
1
Description
Dexmedotidine group (A) and atracurium group (B). Patients in group A receive the following: Dexmedotidine 1 μg / kg + Propofol (3 mg / kg) + Su fentanyl (0.3 μg / kg)
Category
Treatment - Drugs
2
Description
Control group: Patients in group B will receive atracurium 0.5 mg / kg + propofol (3 mg / kg) + su fentanyl (0.3 μg / kg)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar hospital
Full name of responsible person
Mohammad Alipour
Street address
Mashhad- Medical University of Mashhad, Department of Anesthesia and Critical care
City
mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 7402
Email
ghaneisamira@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tafaghodi Mohsen
Street address
Mashahd- Daneshgah street- Ghoreyshi building- Reseach and technology Vice Chancellor
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Email
presidentoffice@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
DR. Mohammad Alipour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Mashhad, Ghaem hospital, Department of Anesthesia and Critical care
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 7402
Email
alipourm@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Alipour Mohammad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Mashhad, Ghaem hospital, Department of Anesthesia and Critical care
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 7402
Email
alipourm@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Ghanei Samira
Position
assistant
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Mashhad, Ghaem hospital, Department of Anesthesia and Critical care
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 7402
Email
ghaneisamira@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as information about the main outcome
When the data will become available and for how long
Access period starts one year after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Only for researchers working in academic and scientific institutions
From where data/document is obtainable
Email
What processes are involved for a request to access data/document