Comparison of the effect of midazolam and ketamine with propofol and ketamine in sedation to patients referring to endoscopy
Design
Randomized double-blind randomized controlled clinical trial based on 128 endoscopic candidate patients with two parallel groups. Randomization is performed by sealed.envelope.com.
Settings and conduct
In this double-blind clinical trial, 128 candidates for endoscopy in Imam Khomeini Hospital in Ahvaz in 2019-2020 were examined. Individuals were randomly assigned to the groups. (The patients and the evaluator are unaware of the drug combination ) In the first group, midazolam was prescribed 0.5 µg/kg + 1 mg /kg of ketamine for each patient with standard weight.In the second group, ketamine was used at the dose of 1 mg / kg + 0.5 µg/ kg of propofol. Then the patient outcomes were recorded and compared between the groups. The depth of relaxation was assessed using the Ramsey criterion. Data analysis was analyzed in SPSS software version 25.
Participants/Inclusion and exclusion criteria
Satisfaction to enter the study; Simultaneous use of some painkillers during colonoscopy; Having a body mass index between 21 and 24
Dissatisfaction with studying; Have a history of high blood pressure, diabetes, respiratory failure and liver and kidney disease, and a history of addiction, heart disease and drug dependence.
Intervention groups
Group (group A) Midazolam and ketamine and for the other group (group B) propofol and ketamine will be prescribed.
Main outcome variables
sedation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200610047723N1
Registration date:2020-10-26, 1399/08/05
Registration timing:retrospective
Last update:2020-10-26, 1399/08/05
Update count:0
Registration date
2020-10-26, 1399/08/05
Registrant information
Name
Mojtaba Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3292 3985
Email address
mojtababagheri1994@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of sedation of midazolam and Ketamine with propofol and Ketamine in patients referring to endoscopy to Imam Khomeini Hospital in Ahwaz
Public title
Sedation of midazolam and ketamine with propofol and ketamine in endoscopy
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Having a body mass index between 21 and 24
Satisfaction to enter the study
The patient is a candidate for endoscopy
Exclusion criteria:
Have a history of high blood pressure, diabetes, respiratory failure and liver and kidney disease, and a history of addiction, heart disease and drug dependence.
Simultaneous use of some painkillers during endoscopy
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Subject were grouped into two parts, with the four block randomization method.The randomization is accomplish by: sealdenvelope.com .Block randomization works by randomizing participants within blocks such that an equal number are assigned to each treatment. Allocation proceeds by randomly selecting one of the 6 blocks, AABB، ABAB، ABBA، BBAA، BAAB and BABA and substitution (number = n/4) till Sample size is accomplished.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to be blind, the patient has no information about which group she/he is in
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Jundishapur University of Medical Sciences, Esfand St., Shahr-e-Daneshgahi, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2020-02-20, 1398/12/01
Ethics committee reference number
IR.AJUMS.REC.1398.388
Health conditions studied
1
Description of health condition studied
sedation for endoscopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
sedation
Timepoint
One hour after the procedure
Method of measurement
(VAS) Visual analoge scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Midazolam is administered intravenously at a dose of 0.05 micrograms per kilogram for each patient of standard weight, followed by 1 mg per kilogram of ketamine as a bolus injection. The need for propolis injection is used at the rate of one third of the initial dose.
Category
Diagnosis
2
Description
Control group: Ketamine is administered as 1 mg per kilogram as bolus, and prophofol is injected at 0.5 micrograms per kilogram. If necessary, midazolam is injected at one-third of the initial dose.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Ehsan Karimi
Street address
Imam Khomeini Educational and Medical Center, Azadegan St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3292 3985
Email
ahvaz@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Baghbanian
Street address
Jundishapur University of Medical Sciences, Esfand St., Shahr-e-Daneshgahi, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
1635715794
Phone
+98 61 6220 3311
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Reza.baghbanian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Jundishapur University of Medical Sciences, Esfand St., Shahr-e-Daneshgahi, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
1635715794
Phone
+98 916 314 8216
Fax
Email
baghbanian.r@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Baghbanian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Jundishapur University of Medical Sciences, Esfand St., Shahr-e-Daneshgahi, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
1635715794
Phone
+98 916 314 8216
Email
baghbanian.r@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ehsan Karimi Namch
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
Jundishapur University of Medical Sciences, Esfand St., Shahr-e-Daneshgahi, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
1635715794
Phone
+98 916 113 5201
Email
info@ajums.ac.ir
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
curd Data file
When the data will become available and for how long
6 month after publish till 10 year after publish in Scientific journals
To whom data/document is available
how formally Correspondence to research vice-chancellor of university
Under which criteria data/document could be used
for using in secondary study
From where data/document is obtainable
research vice-chancellor of university website or correspondent author of article
What processes are involved for a request to access data/document
after get permission of research vice-chancellor of university data were send