Effects of propofol infusion with and without lidocaine on pain and need for sedation during Endoscopic Retrograde Cholangio Pancreatography(ERCP)
Design
This study will be conducted as a randomized clinical trial (blocks of four), double-blind, with parallel groups, without a control group, and phase 2-3, with the participation of 80 patients.
Settings and conduct
This study is a randomized clinical trial (blocks of four), double-blind (participants and results analyzer), with parallel groups, without a control group and phase 2-3 and with the participation of 80 ERCP candidates referred to Imam Reza Hospital (Tabriz) will be done.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: class I to III patients according to ASA and candidates for ERCP, and exclusion criteria include: patients with arterial oxygen saturation less than 90%, heart rate less than 50, and convulsive patients.
Intervention groups
For patients in the intervention group, they will receive 1.5 milligrams of lidocaine per kilogram of weight, and then they will receive 4 milligrams of lidocaine per kilogram of weight in one hour as an infusion, and for patients in the control group, the same amount will be given. Normal saline will be infused. Then propofol will be given as a propofol infusion at a rate of 2 to 4 mg per kilogram of weight per hour.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N33
Registration date:2023-07-19, 1402/04/28
Registration timing:registered_while_recruiting
Last update:2023-07-19, 1402/04/28
Update count:0
Registration date
2023-07-19, 1402/04/28
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-07, 1402/02/17
Expected recruitment end date
2024-05-06, 1403/02/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of propofol infusion with and without lidocaine on pain and need for sedation during Endoscopic Retrograde Cholangio Pancreatography(ERCP)
Public title
Effects of propofol infusion with and without lidocaine on pain and need for sedation during ERCP
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA class I to III patients
ERCP candidate
Exclusion criteria:
Patients with arterial oxygen saturation less than 90%
Heart rate less than 50
Seizure patients
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, with a sample size of 80, we use the patients using the block permutation randomization method, which is used in this method to balance the number of allocated samples, and with 4 people in each block. We assemble the possible blocks as follows. block 1: BBAA, block 2: AABB, block 3: ABAB, block 4: BABA, block 5: ABBA, and block 6: BAAB, we need 20 blocks for 80 people. It is random in the block method. We choose numbers from one to six. For example, if number 6 is chosen as the first block and number 2 as the second block, the people who enter the study will be given BAABAABB in order from left to right. and finally they were divided into two intervention groups (group A) and control group (group B).
Blinding (investigator's opinion)
Double blinded
Blinding description
The thesis results analyst who analyzed the expected outcome and also the participants remained unaware of the type of procedure performed and were blind during the study; Therefore, this study was conducted in a double-blind manner.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2023-05-07, 1402/02/17
Ethics committee reference number
IR.TBZMED.REC.1402.101
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
Once every 10 minutes and for thirty minutes
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Sedation
Timepoint
For a moment and for thirty minutes
Method of measurement
Patient observation
Intervention groups
1
Description
Intervention group: For the patients of this group, 1.5 mg of lidocaine will be injected for each kilogram of weight, and then they will receive 4 mg of lidocaine per kilogram of weight in one hour as an infusion. Then propofol as an infusion. It will be given at a rate of 2 to 4 mg per kilogram of weight per hour. Then, during ERCP, the intensity of pain and the level of sedation will be checked.
Category
Treatment - Drugs
2
Description
Control group: For the patients of this group, 4 cc of normal saline will be infused at the beginning and then 2 to 4 cc per hour. Then propofol will be given as an infusion at a rate of 2 to 4 mg per kilogram of weight per hour. became. Then, during ERCP, the intensity of pain and the level of sedation will be checked.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Marjan Dehdilani
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6165665631
Phone
+98 41 3335 5921
Email
mkhanbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available