Survey of effect of two single doses of bolus Dexmedetomidine (1 µg / kg and 2 µg / kg) on intraoperative hemodynamic status and agitation in the recovery of children undergoing Adenotonsillectomy;
1. Determination and comparison of mean arterial pressure before induction of anesthesia and every 15 minutes during surgery and recovery
2. Determination and comparison of mean heart rate before induction of anesthesia and every 15 minutes during surgery and recovery
3. Determination and comparison of mean SPO2 before induction of anesthesia and every 15 minutes during surgery and recovery
4. Determination and comparison of mean volume of bleeding during surgery based on CC
5. Determine and compare the average length of Intubation
6. Determine and compare the average length of stay in recovery
7. Determine and compare sedation score every 15 minutes
8. Determine and compare agitation score every 15 minutes
9. Determination and comparison of the average dose of propofol for the treatment of delirium
Design
Clinical trial with control group, with 3 parallel groups, double blind, randomized، sample size:105 people
Settings and conduct
The study is a double-blind randomized clinical trial conducted at Imam Hossein Children's Hospital in 1993-1999.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children aged 3 to 10 years are candidates for ASAI, ASAII adenotonsillectomy and consent to participate in the study.Exclusion criteria: include any underlying disease , bleeding disorders, impaired coagulation tests and metabolic disorders
Intervention groups
three groups of 35 each: The first group received 1 µg / kg diluted dexmedetomidine in a volume of 10 ml slowly for ten minutes and the second group received 2 µg / kg diluted dexmedetomidine in a volume of 10 ml slowly for ten minutes and the third group received 10 ml of normal saline slowly. Within 10 minutes
Survey of effect of two single doses of bolus Dexmedetomidine (1 µg / kg and 2 µg / kg) on intraoperative hemodynamic status and agitation in the recovery of children undergoing Adenotonsillectomy;
Public title
Survey of effect of Dexmedetomidine on children undergoing Adenotonslectomy ;
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
3-10 year old childern candidates for adenotonsillectomy
Children who fall into the ASAI, ASAII group in terms of physical condition to determine the risk of anesthesia
Consent to participate in the study
First, 105 eligible patients are selected by simple random sampling, then to divide them into three groups, we use Random Allocation software, so that the code selected by this software for three groups of 35 people in 3 envelopes in packages A, B and C Each envelope will be assigned to one of the three groups by the person who is not involved in the process. For example, envelope A, which contains 35 random codes from 1001 to 1105, will be randomly assigned to one of the three intervention groups 1, or intervention 2, or control, and the syringes will be prepared according to the blinding conditions.
Blinding (investigator's opinion)
Double blinded
Blinding description
To meet the double blindness of the study, doses of both micrograms per kg and one micrograms per kg diluted Dexmedetomidine in a volume of 10 cc are embedded in the syringes. The other syringe will be made without dexmedetomidine and contains only 10 cc Normal saline. The specialist in these syringes will label the A, B and C labels and will provide the researcher daily. Thus, until the data is collected by the nurse, the registrant will not know the type of medication in the syringes. the information analyst will have no knowledge of the types of groups.
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
Before and during anesthesia Every 15 minutes in recovery
Method of measurement
by Pulse oximetr
5
Description
Blood pressure
Timepoint
Before and during anesthesia Every 15 minutes in recovery
Method of measurement
By manometer
6
Description
Heart rate
Timepoint
Before and during anesthesia Every 15 minutes in recovery
Method of measurement
manually
7
Description
Bleeding volume
Timepoint
During surgery
Method of measurement
In milliliter
8
Description
Average dose of propofol for the treatment of delirium
Timepoint
During recovery
Method of measurement
milligram per kilogram
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group : The first intervention group receives 1 micrograms per kilogram of dexmedetomidine manufactured by Elixir Company, which is diluted in a volume of 10 cc as a single dose and bolus and received within ten minutes. Dexmedetomidine with the formula C13H16N2 and with the brand name precedex is one of the Imidazole drugs that has Urinary excretion. It has a half-life of two to three hours and does not have active metabolites. It has a high protein binding (94%). This drug is a pure agonist or a complete alpha-2 receptor agonist. Various methods are used to maintain a stable hemodynamic status and reduce bleeding during surgery. On the other hand, prolonged surgery and instability of hemodynamics are associated with more complications of children's recovery Dexmedetomidine is a central alpha-2 adrenergic agonist that has both sedative and analgesic effects. The use of this drug in children has increased day by day due to its neuroprotective properties. According to the findings so far, dexmedetomidine is one of the few drugs that does not cause cognitive impairment in children after anesthesia.
Category
Treatment - Drugs
2
Description
Intervention group :The second intervention group receives 2 micrograms per kilogram of dexmedetomidine manufactured by Elixir Company, which is diluted in a volume of 10 cc as a single dose and bolus and received within ten minutes.
Category
Treatment - Drugs
3
Description
Control group: 10 cc normal saline
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein Hospital
Full name of responsible person
Hasti Aledavood
Street address
Emam Hossein Hospital, Emam Khomeyni Ave.,
City
Esfahan
Province
Isfehan
Postal code
۸۱۹۵۱۶۳۳۸۱
Phone
+98 31 3386 6266
Fax
+98 31 3386 8286
Email
emamhossein_hospital@mui.ac.ir
Web page address
http://www.ehuch.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Mozhgan Mortazavi (Vice-Chancellery for Research and Technology.)
Street address
Esfahah University of Medical Scineces , Hezarjerib Ave., Darvazeh shiraz Sq.
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 8138
Email
mortazavi@med.mui.ac.ir
Web page address
https://research.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Hasti sadat Aledavood
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 103, Alvand 2 Ave., Ghadir Blvd., Sepahanshahr Town
City
Esfahan
Province
Isfehan
Postal code
8179914387
Phone
0098316515046
Email
hasti.aledavood2@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hasti sadat Aledavood
Position
intern
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No.103,Padideh Bluding, Alvand 2 Ave., Ghadir Blvd., Sepahan shahr Town
City
Esfahan
Province
Isfehan
Postal code
8179914387
Phone
+98 31 3651 5046
Email
hasti.aledavood2@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hasti sadat Aledavood
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 103, Padideh Bluding, Alvand2 Ave., Ghadir Blvd., Sepahanshahr Town
City
Esfahan
Province
Isfehan
Postal code
8179914387
Phone
+98 31 3651 5046
Email
hasti.aledavood2@gmail.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
If necessary, the data can be published without name and with all the details.
When the data will become available and for how long
6 months after printing the results.
To whom data/document is available
Researchers working in popular scientific and academic centers who are employed and studying and have a relevant research in this field that needs my data to advance research.
Under which criteria data/document could be used
If the data of this study is needed to progress and conduct a similar study.
From where data/document is obtainable
The original authors of the study.
What processes are involved for a request to access data/document
The researcher emails a valid letter from his / her work or employment stating the reason for the need for the data and after reviewing it in the research department and after the agreement of the authors and financial support centers, the data and documents are provided to them.