Comparison of midazolam – propofol versus midazolam – ketamin in sedative endoscopy in out patients since April until the end of November 2019 at the Ahvaz Imam Khomeini Hospital
Comparison of midazolam – propofol versus midazolam – ketamin in sedative endoscopy in out patients since April until the end of November 2019 at the Ahvaz Imam Khomeini Hospital
Design
A randomized controlled clinical trial with parallel randomized groups; double blind
Settings and conduct
After obtaining permission from the Ethics Committee of Ahvaz Jundishapur University of Medical Sciences, 78 patients Gastrointestinal Endoscopy in the Endoscopy Department of Imam Khomeini Hospital in Ahvaz The study is selected as a double-blind randomized clinical trial. Prescription drugs are not known) 78 patients will be included in the study
Participants/Inclusion and exclusion criteria
Patients candidate for endoscopy; age 20 to 60 years old; weight 55 to 85 kg; being in ASA class one or two
Intervention groups
One group uses midazolam and propofol and the other group uses midazolam and ketamine.
Main outcome variables
Relaxation; Pain; Nausea and Vomiting; Duration of recovery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191201045566N1
Registration date:2020-09-06, 1399/06/16
Registration timing:retrospective
Last update:2020-09-06, 1399/06/16
Update count:0
Registration date
2020-09-06, 1399/06/16
Registrant information
Name
Nazanin Ahesteh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3340 2531
Email address
mohamadlovely26@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-30, 1398/07/08
Expected recruitment end date
2019-10-20, 1398/07/28
Actual recruitment start date
2019-09-30, 1398/07/08
Actual recruitment end date
2019-10-12, 1398/07/20
Trial completion date
2019-10-12, 1398/07/20
Scientific title
Comparison of midazolam – propofol versus midazolam – ketamin in sedative endoscopy in out patients since April until the end of November 2019 at the Ahvaz Imam Khomeini Hospital
Public title
Comparison of midazolam – propofol versus midazolam – ketamin in sedative endoscopy in out patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All endoscopic patients
Age 20 to 60 years
Weight 55 to 85 kg
Being in ASA class one or two
Exclusion criteria:
Blood pressure history
Diabetes
Respiratory failure
Liver problem
Kidney problem
Addiction
Heart disease
Drug allergy
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
78
Actual sample size reached:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization Method
Individual Randomization Unit
Randomization Tool: Statistical software
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double blind study after the patient is fully aware of the research and the researcher and patient are not aware of the type of prescription drugs.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz University City - Deputy of Research and Technology - Information Office
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-09-28, 1398/07/06
Ethics committee reference number
IR.AJUMS.REC/1398/470
Health conditions studied
1
Description of health condition studied
Endoscopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sedation
Timepoint
From the moment of injection and during injection and after waking up
Method of measurement
Based on the Ramsey variable
2
Description
Comparison of nausea and vomiting in two groups of midazolam - propofol with midazolam - ketamine in patients undergoing outpatient endoscopy
Timepoint
From the end of the procedure to the time of leaving the recovery
Method of measurement
Visual analoge scale
3
Description
Comparison of postoperative pain in patients in two groups of midazolam-propofol with midazolam-ketamine in patients undergoing outpatient endoscopy
Timepoint
At the beginning of the procedure, the end of the procedure and one hour after the end of the procedure
Method of measurement
Ambesh score
4
Description
Comparison of recovery time in patients between the two groups of midazolam-propofol with midazolam-ketamine in patients undergoing outpatient endoscopy
Timepoint
From the time the procedure was completed to the patient's alertness and appropriate response to questions, recovery time was considered (every 30 seconds, recovery was assessed).
Method of measurement
Less than 5 minutes fast, between 5-10 minutes medium and more than 10 minutes slow recovery
5
Description
Comparison of hemodynamic changes in the two groups of midazolam-propofol with midazolam-ketamine in patients undergoing outpatient endoscopy
Timepoint
Vital signs (including heart rate, systolic and diastolic blood pressure, and oxygen saturation) before, and during, induction
Method of measurement
Heart rate per minute and systolic and diastolic blood pressure based on millimeters of mercury and arterial blood oxygen saturation
6
Description
Age, sex and weight in patients in the two groups of midazolam - propofol with midazolam - ketamine in patients undergoing outpatient endoscopy
Timepoint
On arrival
Method of measurement
Age based on number of years of life and weight based on kg and sex based on phenotype
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Both groups were given fentanyl at a dose of 0.5 micrograms per kilogram. In group A, midazolam was administered intravenously at a rate of 0.5 micrograms per kilogram for each patient of standard weight, followed by bolus injection of 0.7 milligrams per kilogram of propofol. If necessary, an infusion of propofol at one-third of the initial dose was used
Category
Other
2
Description
Intervention group: Fentanyl was administered at a dose of 0.5 micrograms per kilogram. In group B, ketamine at a dose of 0.5 milligrams per kilogram was injected as a bolus and midazolam at a dose of 0.5 micrograms per kilogram, if necessary. Propofol infusion was used at a rate of one third of the initial dose.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini hospital
Full name of responsible person
Nazanin Ahesteh
Street address
Azadegan St. - Imam Khomeini Medical Center of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۹۳۶۷۳۱۶۶
Phone
+98 61 3222 2922
Email
himam@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mohammad Badavi
Street address
Golestan Blvd., Shahr-e-Daneshgahi, Esfand St., Ahvaz Jundishapur University of Medical Sciences,
City
Ahvaz
Province
Khouzestan
Postal code
15794 61357
Phone
+98 61 3336 7543
Email
jsmj@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
Dr Reza Baqbanian
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Medical Center of Ahvaz, Azadegan St.
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 0168
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
Dr Reza Baqbanian
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Medical Center of Ahvaz, Azadegan St.
City
Ahvaz
Province
Khouzestan
Postal code
6193643166
Phone
+98 61 3222 0168
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
Nazanin Ahesteh
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Ahvaz Jundishapur University of Medical Sciences, Shahr-e-Daneshgahi, Esfand St., Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 7543
Fax
Email
mohamadlovely26@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All potential data can be shared after unidentified individuals
When the data will become available and for how long
Start of access period 6 months after printing the results
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
For the purpose of scientific research in the field of anesthesia and in compliance with medical ethics
From where data/document is obtainable
Ahvaz - University City - Ahvaz Jundishapur University of Medical Sciences - Central Library Building - First Floor - PO Box: 158 Postal Code: 15794-61357 Phone 3311-061 E-mail: info@ajums.ac.ir
What processes are involved for a request to access data/document
Request by e-mail from the Central Library of Jundishapur University of Medical Sciences and then check the eligibility to provide data to individuals and then the availability of data