Protocol summary

Study aim
Comparison of the effects of dexmedetomidine and ketamine on sphincter tone during endoscopic retrograde cholangiopancreatography (ERCP)
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 84patients. The rand function of Excel software was used for randomization.
Settings and conduct
After connecting the monitoring, the patients are hydrated with normal saline serum, and with 0.3 mg/kg of midazolam and 2 micrograms of fentanyl, propofol infusion of 50 to 70 per hour and divided into three groups, the first group of which is ketamine with a dose of 0.5 µg/ kg, the second group will be injected with 0.5 µg/kg of dexmedetomidine and the third group will be injected with Plaspo drug. Oddi's sphincter tone is measured by the doctor performing the ERCP. For patients in both groups, basic vital signs, including mean arterial blood pressure, heart rate, and blood oxygen saturation percentage, are measured and recorded in the information form. After taking the patient's history and his complete examination and recording the results in the file, a vein is taken from the cubital area. Hemodynamic changes (MAP, HR, Sat o2) are measured and compared at 5, 10, 20 and 30 minutes after drug injection.
Participants/Inclusion and exclusion criteria
Entry criteria: ERCP candidate patients who need anesthesia,
Intervention groups
The first group is ketamine with a dose of 0.5 µg/kg, the second group is 0.5 µg/kg of dexmedetomidine, and the third group is Plaspo drug.
Main outcome variables
Oddi sphincter tone and hemodynamic changes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230817059177N1
Registration date: 2023-10-21, 1402/07/29
Registration timing: registered_while_recruiting

Last update: 2023-10-21, 1402/07/29
Update count: 0
Registration date
2023-10-21, 1402/07/29
Registrant information
Name
Mahrokh Vardipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 933 350 7138
Email address
mahrokh.vardipour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-22, 1402/06/31
Expected recruitment end date
2023-12-20, 1402/09/29
Actual recruitment start date
2023-09-22, 1402/06/31
Actual recruitment end date
2023-12-20, 1402/09/29
Trial completion date
2024-01-19, 1402/10/29
Scientific title
Comparison of the effects of dexmedetomidine and ketamine on Oddi sphincter tone during ERCP
Public title
Comparison of the effects of dexmedetomidine and ketamine on Oddi sphincter tone during ERCP
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ERCP candidate patients who need anesthesia, , in the age range of 18 to 65 years, not suffering from cardiovascular diseases, kidney or liver failure not addicted to drugs, convulsions, not having contraindications for the use of dexmedetomidine, ketamine, which are classified as class 1 and 2 of the association American Anesthesia (ASA) and II, I class are selected
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 84
Actual sample size reached: 84
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are randomly divided into three groups based on the case number, the patients are placed in separate groups based on the case number, the even and odd number on the right, simple cluster randomization, table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, both the patient and the therapist are blinded, including the participants and doctors who do not know which drug they have received
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of ahwaz university of medical sciences
Street address
Golestan highway , ahwaz university of medical science
City
ahwaz
Province
Khouzestan
Postal code
6135715794
Approval date
2023-07-21, 1402/04/30
Ethics committee reference number
IR.AJUMS.REC.1402.251

Health conditions studied

1

Description of health condition studied
ERCP
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The effectof dexmedetomidine on the tone of the sphincter of Audi based on the pain level
Timepoint
5-10-20-30 min of study
Method of measurement
questionnaire

2

Description
The effect of ketamine drug on the sphincter of Audi, drug side effects
Timepoint
5-10-20-30 min of study
Method of measurement
questionnaire

Secondary outcomes

1

Description
level of relaxation
Timepoint
5-10-20-30 min of the study
Method of measurement
questionnaire

2

Description
hypertention
Timepoint
5-10-15-20 min of the study
Method of measurement
questionnaire

3

Description
heartrate
Timepoint
in the procedure of study
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group one : The intervention group of Rotax ketamine (C13H16CINO) with a dose of 0.5 mg per kilogram of weight for 40 seconds intravenously one to three times by Hakim Mehr Company
Category
Treatment - Drugs

2

Description
Intervention group2 : The intervention group of two dexmedetomidine C13H16N2 with a dose of 0.5 mg per kg 50 seconds intravenously one to three times Elixir company
Category
Treatment - Drugs

3

Description
Control group: placebo
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
golestan hospital
Full name of responsible person
مهشید وزیری
Street address
farvardin boulvard, golestan hospital
City
اهواز
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3337 4058
Email
mahrokh.vardipour@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
fatemeh javaherforoshzadeh
Street address
golestan highway , ahwaz university of medical science university
City
ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3314 0000
Email
aduaum@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
mahshid vaziri
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
farvardin boulvard , golestan hospital
City
ahwaz
Province
Khouzestan
Postal code
6335715794
Phone
+98 61 3314 0000
Email
mahrokh.vardipour@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
mahshid vaziri
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
farvardin boulvard. golestan hospital
City
ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3314 0000
Email
mahrokh.vardipour@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
mahshid vaziri
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
farvardin boulvard , golestan hospital
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3314 0000
Email
mahrokh.vardipour@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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
only the data which is associated to result and outcome of study will be published and available for researcher for more research
When the data will become available and for how long
after the study is published, the data will be available
To whom data/document is available
researchers, academic and scientific institution
Under which criteria data/document could be used
in metanalysis and similar study
From where data/document is obtainable
refer to the vice president of research and technology. in addition of giving ethic code of the data will be available for researchers
What processes are involved for a request to access data/document
the researcher can access to the data after getting ethic code from ethic committee of research of jondishapour university by mailing to research and technology unit
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