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A Comparison between the effect of Propofol Fentanyl and Propofol Ketamine on Colonoscopy patients' sedation.

Protocol summary

Study aim
A Comparison between the effect of Propofol Fentanyl and Propofol Ketamine on Colonoscopy patients' sedation.
Design
The clinical trial has two intervention groups, with parallel, double-blind groups randomized on 144 patients, 72 people in each group. Randomization is based on 4 random shifts.
Settings and conduct
After connecting the monitors to the patients in both groups, first the basic vital signs including systolic and diastolic blood pressure, heart rate and blood oxygen saturation percentage are measured and recorded in the questionnaire form. In the first intervention group, 0.5 mg per each kg of Propofol and 0.5 mg per each kg of Ketamine are injected before the procedure. In the second intervention group, 0.5 mg per each kg of Propofol and 1 μg per each kg of Fentanyl are injected before the procedure as well. Then the amount of sedation is measured based on Ramsay score and the amount of patient pain is measured based on Ambesh score at the beginning of the procedure, the end of the procedure and one hour after the end of the procedure.
Participants/Inclusion and exclusion criteria
Patients in the age range of 18 to 65 years, with classification of Group 1 and 2 American Society of Anesthesiologists (ASA Class I & II), are selected as inclusion criteria. As exclusion criteria all patients with drug allergy, age less than 18 or more than 65 years, Kidney or liver failure, people with chronic pain syndromes, the patient's unwillingness to participate in the study, drug addiction, patients with cardiovascular , respiratory, metabolic and neurological diseases, airway problems, ASA class three or four and having a contraindication to Propofol Ketamine or Propofol Fentanyl are excluded from the study.
Intervention groups
In the first intervention group, Propofol Ketamine and in the second intervention group, Propofol Fentanyl is used.
Main outcome variables
pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200818048445N1
Registration date: 2020-10-28, 1399/08/07
Registration timing: registered_while_recruiting

Last update: 2020-10-28, 1399/08/07
Update count: 0
Registration date
2020-10-28, 1399/08/07
Registrant information
Name
Maryam Hosseinpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3376 5834
Email address
hosseinpour.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-18, 1399/01/30
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison between the effect of Propofol Fentanyl and Propofol Ketamine on Colonoscopy patients' sedation.
Public title
A Comparison between the sedative effect of Fentanyl and Ketamine outside the operating room.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
They are between 18 and 65 years old Patients are referred for colonoscopy procedure Classification of Group 1 and 2 American Society of Anesthesiologists (ASA Class I & II) are selected as inclusion criteria.
Exclusion criteria:
the patient's unwillingness to participate in the study They are under 18 years old They are over 65 years old They have kidney failure They have liver failure They have chronic pain syndrome They are addicted They have any drug allergies They have cardiovascular disease They have a respiratory disease They have metabolic diseases They have a neurological disease They have difficult airways The patient is classified as ASA class 3 and 4 Contraindicated propofol ketamine or propofol fentanyl
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 144
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were randomly divided into two groups based on the method of four random blocks.The site www.sealedenvelope.com was used for randomization.If we call the two groups A and B, the logic of randomization is that we select as many samples from the 6 blocks, AABB, BAAB, BBAA, ABBA, ABAB and BABA, by (ie as n / 4)by placing them to reach the sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to double blind the study, the patient's degree of sedation is recorded according to a modified Ramsay standard during the procedure by another person who does not know the medication prescribed to the patient.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Golestan Hospital, Golestan BLVD
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2020-04-13, 1399/01/25
Ethics committee reference number
IR.AJUMS.REC.1399.043

Health conditions studied

1

Description of health condition studied
Pain management of patients referred for Colonoscopy and reduce their anxiety
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
A score of 5 or 6 RAMSAY criteria in the questionnaire. RAMSAY sedation criteria including 6 scores is as follows: 1. Completely awake and anxious 2. Quiet and calm with enough cooperation 3. Asleep and wakes up with a verbal command 4. Asleep and woke up with mild stimulation, but gives a strong reaction to painful stimuli 5. Slow reaction to painful stimuli 6. Lack of reaction to painful stimuli.
Timepoint
5 minutes after the procedure, 10 minutes after the procedure, 15 minutes after the procedure.
Method of measurement
Verbal measurement criteria

Secondary outcomes

1

Description
The amount of pain
Timepoint
Start of procedure , end of procedure and one hour after the end of the procedure
Method of measurement
The Ambesh criterion, which includes the following four-point grading questions: 1. No pain: Negative answer to questions about having pain 2. Mild: Positive answers to questions about having pain, but without any physical symptoms 3. Medium: Positive answers to questions about having pain and the appearance of physical symptoms or successive complaints of pain 4. Intensity: The patient verbally complains of severe pain or shows pain with frowning and upset in the face or turning away with hand or expressing fear.

2

Description
Recovery time
Timepoint
Recovery time is defined as fast (less than 5 minutes), medium (between 5 to 10 minutes) and slow (more than 15 minutes).
Method of measurement
Patient's appropriate answers to questions

3

Description
Nausea
Timepoint
Every 5 minutes
Method of measurement
It is expressed by the person herself/himself

4

Description
Systolic blood pressure
Timepoint
Every 5 minutes
Method of measurement
Blood pressure monitor

5

Description
Diastolic blood pressure
Timepoint
Every 5 minutes
Method of measurement
Blood pressure monitor

6

Description
heart beat
Timepoint
every 5 minutes
Method of measurement
Cardiac monitor

7

Description
Arterial blood oxygen saturation
Timepoint
Every 5 minutes
Method of measurement
Respiratory monitor

Intervention groups

1

Description
The first intervention group: The group receiving Propofol Fentanyl for sedation during Colonoscopy.
Category
Treatment - Drugs

2

Description
Intervention group 2: The group receiving Propofol Ketamine for sedation during Colonoscopy.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Reza Baghbanian
Street address
No.1519 , Shahid Ahvazian Ave, Azadegan St. Ahvaz Imam Khomeini Medical Center
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3221 6504
Fax
+98 61 3222 5763
Email
hosseinpour.m@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
No 123/1 , 3d Phase , West Mordad St, Chamran Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6155644379
Phone
+98 61 3376 5834
Email
hosseinpour.m@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
Baghbanian reza
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
NO.123/1, 3d Phase, West Mordad St, Chamran Blvd, Kian Pars
City
Ahvaz
Province
Khouzestan
Postal code
6155644379
Phone
+98 61 3376 5834
Fax
Email
hosseinpour.m@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Baghbanian reza
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
NO.123/1, West Mordad Ave, Chamran Blvd, Kiyan Pars
City
Ahvaz
Province
Khouzestan
Postal code
6155644379
Phone
+98 61 3376 5834
Fax
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
Hosseinpour Maryam
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
NO.123/1,3d Phase, West Mordad St, Chamran Blvd, Kian Pars
City
Ahvaz
Province
Khouzestan
Postal code
6155644379
Phone
+98 61 3376 5834
Fax
Email
hosseinpour.m@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The Excel file contains the identification code, reference to the file number and the registered information, except for the documents that can be provided.
When the data will become available and for how long
6 months after printing the results until 10 years later
To whom data/document is available
All those who officially correspond with the Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
Under which criteria data/document could be used
Documents can be used for systematic review studies and meta-analysis
From where data/document is obtainable
Vice Chancellor for Research Ahvaz Jundishapur University
What processes are involved for a request to access data/document
After approval from the Vice Chancellor for Research, the data file will be provided to the Vice Chancellor and then the data will be shared with other researchers or emailed to them.
Comments
The material and intellectual property of this project is with Ahvaz University of Medical Sciences
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