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Comparison of the Effects of Metoclopramide and Lidocaine on Reducing Pain During Propofol IV Injection in general anesthesia induction with or without tourniquet , Kosar hospital , Semnan ,2021

Protocol summary

Study aim
Comparison of the Effects of Metoclopramide and Lidocaine on Reducing Pain During Propofol Injection with or without tourniquet ,Semnan ,2021
Design
Clinical trial, with parallel groups, not blinded, randomized, on 120 patients, There are two drugs in total (A B), each in two states with and without tourniquets , These names were introduced to the software and the software was run to assign equal samples to each group.
Settings and conduct
120 patients is randomly divided into 4 groups. L1, after injecting 40 mg of lidocaine, wait 30 seconds and inject a quarter of Propofol. L2, after using the tourniquet, inject Lidocaine, and after 30 seconds, release the tourniquet and immediately inject a quarter of Propofol. M1, after injecting 10 mg of metoclopramide, we follow L1. M2, after using the tourniquet, metoclopramide is injected and we act according to L2 group. Finally, pain intensity is assessed based on (VRS) criteria.
Participants/Inclusion and exclusion criteria
Candidates for elective surgery who require general anesthesia. Eligible for ASA 1 and 2 who have no history of drug, analgesic and are not allergic to propofol, lidocaine, and metoclopramide, or who have chronic pain syndromes, neurological disease, or psychiatry. have. Patients should be able to communicate verbally and not be pregnant.
Intervention groups
L1: injection of 2 mg / kg Propofol at a rate of 0.5 cc per second after injection of 40 mg lidocaine L2: injection of 2 mg / kg Propofol at a rate of 0.5 cc per second after injection of 40 mg lidocaine by using the tourniquet M1: injection of 2 mg / kg Propofol at a rate of 0.5 cc per second after injection of 10 mg metoclopramide M2: injection of 2 mg / kg Propofol at a rate of 0.5 cc per second after injection of 10 mg metoclopramide by using the tourniquet
Main outcome variables
The severity of immediate pain on VRS. (0) (1) (2) (3)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211101052932N1
Registration date: 2022-02-12, 1400/11/23
Registration timing: registered_while_recruiting

Last update: 2022-02-12, 1400/11/23
Update count: 0
Registration date
2022-02-12, 1400/11/23
Registrant information
Name
parinaz mirakhorli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3334 5917
Email address
parinaz.mir1997@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Metoclopramide and Lidocaine on Reducing Pain During Propofol IV Injection in general anesthesia induction with or without tourniquet , Kosar hospital , Semnan ,2021
Public title
Comparison of the Effects of Metoclopramide and Lidocaine on Reducing Pain of Propofol with or without tourniquet
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients must be in the American Society of Anesthesiology or ASA Class 1 and 2 . Have the ability to communicate verbally. All patients undergoing elective surgery who require general anesthesia, regardless of the type of surgery and the individual's disease.
Exclusion criteria:
People who are pregnant. Patients with a history of hypnotic, narcotic, or analgesic use in the 24 hours before the surgery or have a history of drug, analgesic, or alcohol dependence. Patients who are prohibited from taking Propofol (including allergies to foods such as eggs, soybeans, and Propofol), prohibition of lidocaine or metoclopramide, or other nonsteroidal anti-inflammatory drugs (NSAIDs). Patients with chronic pain syndromes, neurological or psychological diseases.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
There are two drugs in total (A B), each in two states with and without tourniquets (0 and 1), which can be 4 general cases with these names: A0 A1 B0 B1 These names were introduced to the software and the software was run to assign equal samples to each group. The output list of the software will be the criterion for action. https://www.random.org/lists/ For random assignment to 4 groups, the names of each group up to 30 (each item in a row) were entered in the software box and executed in the software. In this way, the software has separate boxes In the first box 30 times A0 In the second box 30 times A1 In the third box 30 times B0 B1 is placed in the fourth box 30 times The software has a key that by hitting it, the software itself randomizes the data
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
no

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Semnan University of Medical Sciences - Research and development Vice
Street address
Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2021-10-26, 1400/08/04
Ethics committee reference number
IR.SEMUMS.REC.1400.184

Health conditions studied

1

Description of health condition studied
Each patient is a candidate for elective surgery who uses Propofol for anesthesia.(Comparison of the Effects of Metoclopramide and Lidocaine on Reducing Pain During Propofol IV Injection with or without tourniquet in general anesthesia induction )
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain score in VRS questionnaire
Timepoint
Immediately after intravenous injection of a quarter of Propofol in induction of anesthesia
Method of measurement
Pain intensity is assessed according to the Verbal Rating Scale(VRS)

Secondary outcomes

empty

Intervention groups

1

Description
Group L1: injection of 2 mg / kg Propofol at a rate of 0.5 cc per second after injection of 40 mg Lidocaine
Category
Treatment - Drugs

2

Description
Group L2: injection of 2 mg / kg Propofol at a rate of 0.5 cc per second after injection of 40 mg lidocaine by using the tourniquet
Category
Treatment - Drugs

3

Description
M1: injection of 2 mg / kg Propofol at a rate of 0.5 cc per second after injection of 10 mg Metoclopramide
Category
Treatment - Drugs

4

Description
Group M2: injection of 2 mg / kg Propofol at a rate of 0.5 cc per second after injection of 10 mg metoclopramide by using the tourniquet
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Hospital in Semnan
Full name of responsible person
Parinaz Mirakhorli
Street address
Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 1022
Fax
+98 23 3343 7837
Email
info@semums.ac.ir
Web page address
http://semums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Koukhaei
Street address
Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 1022
Fax
+98 23 3343 7837
Email
info@semums.ac.ir
Web page address
http://semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Abolfazl Abdollahpour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 1022
Fax
+98 23 3343 7837
Email
felordce@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parinaz Mirakhorli
Position
Medical Extern
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 1022
Fax
+98 23 3343 7837
Email
info@semums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parinaz Mirakhorli
Position
medical extern
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Semnan University of Medical Sciences
City
semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 1022
Fax
+98 23 3343 7837
Email
kosarhos@semums.ac.ir
Web page address
http://semums.ac.ir

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
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