Comparison of the sedative efficacy of propofol-ketamine combination versus propofol-ketamine plus lidocaine spray in outpatient endoscopy
Design
The clinical trial has two intervention groups, with parallel, double-blind groups randomized on 154 patients, 77 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 vital signs including systolic and diastolic blood pressure, heart rate and blood oxygen saturation percentage are measured and record the result in the file,a vein is taken from the cubital area.
In the first group, 0.5 mg per kg of propofol plus 0.5 mg per kg of ketamine and in the second group 0.5 mg per kg of propofol and 0.5 mg per kg of ketamine and then 2 puffs of spray. 10% lidocaine equals 20 grams.Then the amount of sedation is measured based on Ramsay score and the nausa and vomiting of patients based on visual analogue score from the end of the procedure until the time of recovery will be recorded.
Participants/Inclusion and exclusion criteria
Candidate patients for endoscopy who require anesthesia in the age range of 18 to 65 years old with Classification of Group 1 American Society of Anesthesiologists (ASA Class I) are selected as inclusion criteria.
As exclusion criteria,the patient's unwillingness to participate in the study,age less than 18 years or more than 65 years,cardiovascular disease
,kidney failure or liver failure,drug addiction,having contraindication to propofol ketamine or lidocaine spray or patient with esophageal or gastric perforation during the procedure,Changing the type of procedure during endoscopy or the need for surgery are excluded from the study.
Intervention groups
In the first intervention group, Propofol Ketamine and in the second intervention group, Propofol Ketamin plus Lidocaine spray is used.
Main outcome variables
sedation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201027049160N1
Registration date:2020-11-04, 1399/08/14
Registration timing:registered_while_recruiting
Last update:2020-11-04, 1399/08/14
Update count:0
Registration date
2020-11-04, 1399/08/14
Registrant information
Name
Sheida Kiamohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3391 3455
Email address
kiamohammadi.sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the sedative efficacy of propofol-ketamine combination versus propofol-ketamine plus lidocaine spray in outpatient endoscopy
Public title
Comparison of sedative efficacy of propofol-ketamine versus propofol-ketamin plus lidocaine spray outside the operating room
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for endoscopy who require anesthesia
In the age range of 18 to 65 years old
Classification of Group 1 American Society of Anesthesiologists (ASA Class I) are selected as inclusion criteria
Exclusion criteria:
the patient's unwillingness to participate in the study
Age less than 18 years or more than 65 years
They have cardiovascular disease
They have kidney failure or liver failure
They are addicted
Contraindicated propofol ketamine or lidocaine spray
Esophageal or gastric perforation during the procedure
Esophageal or gastric bleeding during the procedure
Changing the type of procedure during endoscopy or the need for surgery
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:
154
Randomization (investigator's opinion)
Randomized
Randomization description
The number of patients will be randomly divided into four groups based on the case number.
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
کمیته اخلاق در پژوهش دانشگاه علوم پزشکی جندی شاپور اهواز
Street address
Golestan Hospital, Golestan BLVD
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2020-06-07, 1399/03/18
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1399.011
Health conditions studied
1
Description of health condition studied
Sedation management of patients referred for Endoscopy 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 stimulition
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
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
2
Description
nausa and vomiting of patients based on visual analogue score from the end of the procedure until the time of recovery will be recorded.
Timepoint
Every 5 minutes
Method of measurement
It is expressed by the person herself/himself
3
Description
Blood pressure
Timepoint
Every 5 minutes
Method of measurement
Blood pressure monitor
4
Description
Heart beat
Timepoint
Every 5 minute
Method of measurement
Cardaic monitor
5
Description
Arterial blood oxygen saturation
Timepoint
Every 5 minutes
Method of measurement
Respiratory monitor
Intervention groups
1
Description
Control group: The group receiving Propofol Ketamin for sedation during Endoscopy.
Category
Treatment - Drugs
2
Description
Intervention group: The group receiving Propofol Ketamin plus Lidocaine spray for sedation during Endoscopy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Reza Akhondzade
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
kiamohammadi.sh@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Akhondzade
Street address
Unit 3,Second floors,Ferdos Building,NO.57,Second West Street,Phase One,Chamran Blvd,kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155819931
Phone
+98 61 3391 3455
Email
rezaakh@hotmail.com
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 Akhondzade
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Unit 3,Second floors,Ferdos Building,NO.57,Second West Street,Phase One,Chamran Blvd,kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155819931
Phone
+98 61 3391 3455
Email
Kiamohammadi.sh@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Akhondzade
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Unit 3,Second floors,Ferdos Building,NO.57,Second West Street,Phase One,Chamran Blvd,kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155819931
Phone
+98 61 3391 3455
Email
Rezaakh@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sheida Kiamohammadi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Unit 3,Second floors,Ferdos Building,NO.57,Second West Street,Phase One,Chamran Blvd,kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155819931
Phone
+98 61 3391 3455
Email
Kiamohammadi.sh@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.