The effect of intravenous lidocaine on sore throat, myalgia and fasciculation induced by succinylcholine in patients undergoing appendectomy
Design
This double blind, randomized, study with Parallel groups will be conducted on 90 patients undergoing appendectomy Patients will be randomly assigned to two groups by throwing the coins. The first intervention group will receive lidocaine 2% intravenously with a dose of 1.5 mg / kg. The second intervention group: As a control group, will receive normal saline solution at 0.075 ml / kg.
Settings and conduct
This randomized study will be carried out in patients undergoing appendectomy referring to Shahid Mohammadi Hospital in Bandar Abbas. Patients who have criteria for entering the study by throwing the coin will be divided into two groups and the rate of fasciculation , sore throat and myalgia in two groups Will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People aged 15 to 70 years, people undergoing appendectomy surgery. exclusion criteria: Individuals with musculoskeletal disorders, increased intracranial pressure, increased intraocular pressure
Intervention groups
First intervention group: will receive Lidocaine2% at dose of 1.5 mg / kg. The second intervention group: As a control group, will receive normal saline solution at 0.075 ml / kg.
Main outcome variables
The rate of fasciculation , Severity of sore throat and Severity of myalgia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190528043737N1
Registration date:2019-10-06, 1398/07/14
Registration timing:registered_while_recruiting
Last update:2019-10-06, 1398/07/14
Update count:0
Registration date
2019-10-06, 1398/07/14
Registrant information
Name
Mehrdad Malekshoar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 3280
Email address
mehrdad.malekshoar@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-10, 1396/07/18
Expected recruitment end date
2019-11-10, 1398/08/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intravenous lidocaine on sore throat, myalgia and Fasciolasion induced by succinylcholine in appendectomy surgery.
Public title
effect of intravenous lidocaine on sore throat induced by succinylcholine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
appendectomy surgery.
Exclusion criteria:
Musculoskeletal disorders
increased intracranial pressure
increased intraocular pressure
history of malignant hyperthermia
Lidocaine susceptibility
Hyperkalemia
Age
From 15 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The participants in the present study will be divided into two intervention and control groups by throwing coins.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the present study, participants in the study were unaware of which individuals were in the group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Bandar Abbas Shahid Chamran Blvd.
City
Hormozgan
Province
Hormozgan
Postal code
7914964157
Approval date
2016-12-26, 1395/10/06
Ethics committee reference number
HUMS.REC.039
Health conditions studied
1
Description of health condition studied
Appendicitis
ICD-10 code
K35.80
ICD-10 code description
Unspecified acute appendicitis
Primary outcomes
1
Description
The severity of the fasciculation
Timepoint
Immediately after injection of succinylcholine
Method of measurement
Under the Mings Crypt
2
Description
The severity of the sore throats
Timepoint
24 hours after surgery
Method of measurement
By asking the patient in relation to throat pain
3
Description
Severity of myalgia
Timepoint
24 hours after surgery
Method of measurement
Based on the Harvey criterion
Secondary outcomes
1
Description
Changes in blood pressure
Timepoint
Before, immediately after the intubation, 5, 10, 15 minutes after the operation, and during the operation at 10-minute intervals
Method of measurement
Using the blood pressure device
Intervention groups
1
Description
Intervention group: : will receive Lidocaine 2% at dose of 1.5 mg / kg
Category
Treatment - Drugs
2
Description
Control group: will receive normal saline solution at 0.075 ml / kg
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Mehrdad Malek Shoar
Street address
Bandar Abbas Shahid Chamran Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964157
Phone
+98 76 3333 3280
Email
mdmalekshoar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Mehrdad Malek Shoar
Street address
Bandar Abbas Shahid Chamran Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964157
Phone
+98 76 3333 3280
Email
mdmalekshoar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Mehrdad Malek Shoar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bandar Abbas Shahid Chamran Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964157
Phone
+98 76 3333 3280
Email
mdmalekshoar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Mehrdad Malek Shoar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bandar Abbas Shahid Chamran Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964157
Phone
+98 76 3333 3280
Email
mdmalekshoar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Mehrdad Malek Shoar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bandar Abbas Shahid Chamran Blvd.
City
Bandar Abbas ب
Province
Hormozgan
Postal code
7914964157
Phone
+98 76 3333 3280
Email
mdmalekshoar@yahoo.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