The comparison of the effect of sedative of Dexmedetomidine and Fentanyl with Propofol and Fentanyl in participants undergoing colonoscopy
Design
Clinical trials with a hospital-based and pragmatic control group with parallel, randomized groups, Group 1: Treated with Propofol and Fentanyl, Group 2: Dexmedetomidine and Fentanyl, randomization method Simple randomization, randomization unit: Individual, randomization tool: Random number table, no blinded, The total sample size of 70 patients candidates for elective colonoscopy, clinical trial phase: 2.
Settings and conduct
Colonoscopy is a standard and common method for the diagnosis and screening, treatment and prevention of many colon diseases that can be performed in some centers without analgesic sedation. The aim of the study was the comparison of the effect of sedative of Dexmedetomidine and Fentanyl in comparison with Propofol and Fentanyl in patients undergoing colonoscopy. Patients referred to the Sina hospital who was candidates for elective colonoscopy. Group 1: Treated with Ketamine and Fentanyl, Group 2: Dexmedetomidine and Fentanyl, randomization method Simple randomization, randomization tool: Random number table, The total sample size of 70 patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Participants with ASA grade I and II and candidates for elective colonoscopy. Exclusion criteria: Participants with complete heart block, liver failure, severe heart failure.
Intervention groups
Group 1: Treated with Propofol and Fentanyl, Group 2: Dexmedetomidine and Fentanyl.
Main outcome variables
Relaxation; Pain.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170805035510N4
Registration date:2019-05-22, 1398/03/01
Registration timing:retrospective
Last update:2019-05-22, 1398/03/01
Update count:0
Registration date
2019-05-22, 1398/03/01
Registrant information
Name
Pejman Pourfakhr
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4466 3963
Email address
pourfakhr@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-23, 1397/03/02
Expected recruitment end date
2019-03-02, 1397/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of sedative of Dexmedetomidine and Fentanyl with Propofol and Fentanyl in participants undergoing colonoscopy
Public title
Determination of the effect of sedative of Dexmedetomidine and Fentanyl with Propofol and Fentanyl in participants undergoing colonoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA Class I, II
Exclusion criteria:
Patients with complete heart block
Liver failure
Severe heart failure
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization, randomization unit: individual, randomization tool: random number table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences and Health services
Street address
Tehran University of Medical Sciences, Central Building, Ghods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-07-02, 1396/04/11
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.2762
Health conditions studied
1
Description of health condition studied
Participants candidates for colonoscopy for diagnosis any disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sedation
Timepoint
After colonoscopy
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Pain
Timepoint
After colonoscopy
Method of measurement
Visual Analogue Scale (VAS)
Intervention groups
1
Description
Intervention group: Combination of Propofol and Fentanyl, Once before colonoscopy the dosage was injectable ketamine Propofol 500 mg/ml) and fentanyl (fentanyl 1 μg/kg). Propofol, as Diprivan among other names, is a short-acting medication that results in a decreased level of consciousness and lack of memory for events. Fentanyl provides some of the effects typical of other opioids through its agonism of the opioid receptors.
Category
Treatment - Drugs
2
Description
Control group: The combination of doxedemotomidine and fentanyl was administered once prior to colonoscopy by dose of 1 mg / kg dx dimethomidine and 1 μg / kg fentanyl intravenously. Dexmedetomidine, sold under the Precedex brand among others, is a reduction in thirst, sedation, and pain medications. Fentanyl through opioid receptor agonists provides some of the commonality of other drugs.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Pejman Pourfakhr
Street address
Sina hospital, Hasan abad Square, Imam Khomeini St.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
pourfakhr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyedeh Elham Kavousi
Street address
Tehran University of Medical Sciences, Central Building, Ghods Ave., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
pourfakhr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Pejman Pourfakhr
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina hospital, Hasan abad square, Emam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 8863 5770
Email
pourfakhr@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pejman Pourfakhr
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina hospital, Hasan abad square, Emam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 8863 5770
Email
pourfakhr@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pejman Pourfakhr
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina hospital, Hasan abad square, Emam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 8863 5770
Email
pourfakhr@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Print article
When the data will become available and for how long
8 months
To whom data/document is available
Medical students
Under which criteria data/document could be used
Print article
From where data/document is obtainable
Pejman Pourfakhr
What processes are involved for a request to access data/document