In order to compare the sedative effect of ketamine and propofol with oral midazolam during upper gastrointestinal endoscopy 94 children 1-14 years old with gasterointestinal disease and classification 1 and 2 ASA( American Society of Anesthesiologists) with chronic disease, cardiovascular and do not use effective drugs on the cardiovascular system and nervous system;during 6 months observing and studing in two groups of oral midazolam with ketamine and oral midazolam with propofol.record certain vital signs (heart rate, respiratory rate, mean arterial pressure, oxygen saturation) at different times, the need for additional doses of the drug and level of sedation effect of both regime.The results obtained during upper gastrointestinal endoscopy compared to sedative drug regimens will be studied.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121831457N1
Registration date:2017-02-15, 1395/11/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-15, 1395/11/27
Registrant information
Name
Mahdi Farhadi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3234 2151
Email address
m.farhadi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2016-11-10, 1395/08/20
Expected recruitment end date
2017-05-10, 1396/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison assessment the sedative effect of ketamine and propofol with oral midazolam in pediatric upper gastrointestinal endoscopy
Public title
The comparison assessment the sedative effect of ketamine and propofol with oral midazolam in pediatric upper gastrointestinal endoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:1-14 years old childs with gasterointestinal disease ; children with grade I, II classification (American Society of Anesthesia) ASA
Exclusion Criteria: chronic diseases such as cardio-pulmonary disease, diabetes, infectious diseases and oncology ; chronic use of drugs affecting the respiratory system and cardiovascular, CNS
Age
From 1 year old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences, Ganjafroz Street, Babol, Mazandaran Province, IR Iran. 4717647745 Tel: 00981132199591 Fax: 00981132194727 info@mubabol.ac.ir
City
babol
Postal code
4717647745
Approval date
2016-11-09, 1395/08/19
Ethics committee reference number
MUBABOL.HRI.REC.1395.45
Health conditions studied
1
Description of health condition studied
sedation effect of drug regimen in gasterointetinal endoscopy
ICD-10 code
R10
ICD-10 code description
Abdominal and pelvic pain
2
Description of health condition studied
sedation effect of drug regimen in gasterointetinal endoscopy
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
3
Description of health condition studied
sedation effect of drug regimen in gasterointetinal endoscopy
ICD-10 code
R12
ICD-10 code description
Heartburn
4
Description of health condition studied
sedation effect of drug regimen in gasterointetinal endoscopy
ICD-10 code
R13
ICD-10 code description
Dysphagia
5
Description of health condition studied
sedation effect of drug regimen in gasterointetinal endoscopy
ICD-10 code
R19
ICD-10 code description
Other symptoms and signs involving the digestive system and abdomen
Primary outcomes
1
Description
check the heart rate after administration of oral midazolam and ketamine and propofol sedative drugs
Timepoint
1)Two minutes after administration of oral midazolam 2) When entering the endoscope 3) five minutes after endoscopic
The possible need to add a dose of medication ine MK groups as inadequate sedation with commonly defined doses
Timepoint
during endoscopy if inadequate sedation
Method of measurement
The milligrams of the drug
Secondary outcomes
1
Description
Compare vital signs after endoscopy
Timepoint
Fifteen minutes after the completion of endoscopy
Method of measurement
vital sign monitorin mashine(saadat)
2
Description
The endoscopist satisfaction of sedation effect of each drug regimen
Timepoint
After the endoscopy
Method of measurement
Skills and experience of the endoscopist
3
Description
Compare potential drug side effects in both groups.
Timepoint
After drug administration, during endoscopy,finish endoscopغ
Method of measurement
Phisical exam and History
4
Description
compare of recavery score
Timepoint
Fifteen minutes after the completion of endoscopy
Method of measurement
steward score system
Intervention groups
1
Description
In MP group oral midazolam half-mg dose and a maximum of 20 milligrams per kilogram of body weight
Category
Treatment - Other
2
Description
Patients in the MP group injected with Propofol (Dayateb co.IRof Iran Manufactured by Claris) bolus dose2 mg / kg (children younger than 3 years) and 1 mg / kg (in children older than 3 years) are to 5≤ (RSS) arrive and then propofol infusion at a dose of 100μ / kg / min maintenance dose for sedation begins
Category
Other
3
Description
MK Group IV sedation with ketamine in slow (Trittan / Germany) bolus1-2 mg / kg starts and after about 15-10 minutes the effect of ketamine sedation was reduced by as much as 0/5-1 mg / kg in during the procedure is repeated
Category
Other
4
Description
In MK group oral midazolam half-mg dose and a maximum of 20 milligrams per kilogram of body weight
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafizade Pediatric Hospital
Full name of responsible person
Dr Mohammadreza Esmaeili Dooki
Street address
Children’s Hospital, Amirkola, Babol, Mazandaran Province 4731741151, IR Iran. Tel: 00981132354951 Fax: 00981132340656 Phone Num: 00989111112284 esmaeilidooki@yahoo.com
City
Babol , Amirkola
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Aliakbar Moghadamnia
Street address
Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences, Ganjafroz Street, Babol, Mazandaran Province, IR Iran. 4717647745 Tel: 00981132199591 Fax: 00981132194727 info@mubabol.ac.ir
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Amirkola Childeren's Hospital
Full name of responsible person
Dr Mahdi Farhadi
Position
Peditric's Assistant
Other areas of specialty/work
Street address
No 19, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province 4731741151, IR Iran. Babo
City
Babol Amirkola
Postal code
4731741151
Phone
+98 11 3234 2151
Fax
Email
M.farhadi@mubabol.ac.ir ,
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical University of Babol
Full name of responsible person
Dr Mohamad Reza Esmaeili Dooki
Position
Pediatric Gastroenterologist
Other areas of specialty/work
Street address
No 19, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province 4731741151, IR Iran.
City
Babol Amirkola
Postal code
4731741151
Phone
+98 11 3234 2151
Fax
Email
Esmaeilidooki@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shafiezade Children's Hospital
Full name of responsible person
Dr Mahdi Farhadi
Position
Pediatric's Assistant
Other areas of specialty/work
Street address
No 19, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province 4731741151, IR Iran. Babo
City
Babol Amirkola
Postal code
4731741151
Phone
+98 11 3234 2151
Fax
Email
M.farhadi@mubabol.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)