Determination and comparison the effect of
remifentanil with intravenous lidocaine in controlling the
cardiovascular response to laryngeal mask airway insertion in general anesthesia
Design
Clinical trial with control group, double-blind, randomized,
phase 2 in 60 patients
Settings and conduct
This double blind randomized clinical trial performs in Shahroud's Imam Hossein hospital. Patients with inclusion criteria, after justification and informed concern according simple randomization assigns to control or intervention group. Anesthetist, records the group's type in participant's questionnaire that has two portion with identical cod and then separates data recording portion and gives it to person who is responsible of outcome recording and is unaware of patient grouping. syringes of remifentanil and lidocaine will be ready in identical shape and volume
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male or female 18 - 60 years old - Open limbs surgery under general anesthesia - Class 1 and 2 of anesthesia risk (According to American society of anesthesiologist's classification)
Exclusion criteria: Difficult LMA placements - Repeated attempts at LMA insertion - Prolonged ( more than 30 seconds) LMA insertion
Intervention groups
Intervention group: Management of anesthesia in both groups are identical. Participants in intervention group after induction of anesthesia receives intravenous Remifentanil with a dose of 1.5 microgram/kg, and after 2 minutes ventilation Laryngeal Mask Airway will be inserted.
Control group: participants in control group after induction of anesthesia receives intravenous Lidocaine with a dose of 1.5 mg/kg, and after 2 minutes ventilation Laryngeal Mask Airway will be inserted.
Main outcome variables
Systolic blood pressure, Diastolic blood pressure and Pulse rate before and after induction of anesthesia and following LMA insertion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181229042169N1
Registration date:2020-12-07, 1399/09/17
Registration timing:registered_while_recruiting
Last update:2020-12-07, 1399/09/17
Update count:0
Registration date
2020-12-07, 1399/09/17
Registrant information
Name
Batool Chopani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3234 2000
Email address
batool_chopani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-04-18, 1400/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of remifentanil and lidocaine on controlling the cardiovascular response to laryngeal mask airway insertion following general anesthesia
Public title
Comparison of intravenous remifentanil and intravenous lidocaine in prevention of cardiovascular response to laryngeal mask airway insertionl following anesthesia in limbs surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female 18 - 60 years old
Open limbs surgery under general anesthesia
Class 1 and 2 of anesthesia risk (According to American society of anesthesiologist's classification)
Exclusion criteria:
Difficult LMA placements
Repeated attempts at LMA insertion
Prolonged ( more than 30 seconds) LMA insertion
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple blind randomization
Sixty identical sheets( 30 control and 30 intervention) were mixed in a bag
and randomly one sheet brings out and the patients assigns to one group according this sheet and then the sheet is
left out.
Blinding (investigator's opinion)
Double blinded
Blinding description
Anesthesiologist and nurse anesthesia are aware of patient's group and this group is recorded in questionnaire by them. Questionnaire has two portion with identical cod. Nurse anesthesia separates data recording portion and gives it to person who is responsible of outcome recording and is unaware of patient grouping.
syringes of remifentanil and lidocaine will be ready in identical shape and volume
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud university of medical sciences
Street address
Shahroud university of medical sciences , 7tir sq
City
shahroud
Province
Semnan
Postal code
36147-73947
Approval date
2017-03-06, 1395/12/16
Ethics committee reference number
IR.SHMU.REC.1395.184
Health conditions studied
1
Description of health condition studied
Open reduction and internal fixation of ulna and radiusfracture
ICD-10 code
S52.4
ICD-10 code description
Fracture of shaft of radius
Primary outcomes
1
Description
systolic Blood pressure
Timepoint
Before induction of anesthesia - after induction of anesthesia - and immediately after laryngeal mask airway insertion
Method of measurement
Non-invasive blood pressure measurement with Novin Saadat monitor.
2
Description
Diastolic blood pressure
Timepoint
Before induction of anesthesia - after induction of anesthesia - and immediately after laryngeal mask airway insertion
Method of measurement
Non-invasive blood pressure measurement with Novin Saadat monitor.
3
Description
Pulse rate
Timepoint
Before induction of anesthesia - after induction of anesthesia - and immediately after laryngeal mask airway insertion
Method of measurement
Non-invasive blood pressure measurement with Novin Saadat monitor.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: participants in intervention group after induction of anesthesia receives intravenous Remifentanil with a dose of 1.5 microgram/kg, and after 2 minutes ventilation Laryngeal Mask Airway will be inserted.
Category
Treatment - Drugs
2
Description
Control group: participants in control group after induction of anesthesia receives intravenous Lidocaine with a dose of 1.5 mg/kg, and after 2 minutes ventilation Laryngeal Mask Airway will be inserted.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Javad Nourian
Street address
End of Ayatollah Towheedi Blvd.
City
SHAHROUD
Province
Semnan
Postal code
3616911151
Phone
+98 23 3234 2001
Fax
+98 23 3233 3902
Email
Javadnourian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr Javad Nourian
Street address
Shahroud Haft Tir Square Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
36147_73947
Phone
+98 23 3239 5054
Fax
+98 23 3233 3901
Email
Mtkzf.ms@gmail.com
Web page address
http://shmu.ac.ir/emh/fa
Grant name
Shahroud university of medical sience
Grant code / Reference number
+98 23 3239 5054
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Dr Javad Nourian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahroud Haft Tir Square Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3239 5054
Email
javadnourian@gmail.com
Web page address
http://shmu.ac.ir/emh/fa
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr Javad Nourian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahroud Haft Tir Square Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3239 5054
Email
Mtkzf.ms@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr Javad Nourian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahroud Haft Tir Square Shahroud University of Medical Sciences
City
SHAHROUD
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3239 5054
Email
Mtkzf.ms@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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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