Comparison of intravenous remifentanil and lidocaine on the cardiovascular response to laryngoscopy and tracheal intubation under general anesthesia in open limbs surgery.
Determination and comparison of the effect of remifentanil with intravenous lidocaine in controlling the cardiovascular response to laryngoscopy and endotracheal intubation in general anesthesia
Design
Clinical trial with control group, double-blind, randomized, phase 2 in 60 patients
Settings and conduct
Sixty patients were divided into two intervention and control groups by double-blind method and this study was performed in the operating room
Participants/Inclusion and exclusion criteria
Open limb surgery under general anesthesia and the risk of one and two anesthesia
Cases of difficult intubation and any problems with laryngoscopy and intubation
Intervention groups
A group of 30 people received Remy Fentanyl
Main outcome variables
Blood pressure
Pulse rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200501047255N1
Registration date:2020-07-27, 1399/05/06
Registration timing:retrospective
Last update:2020-07-27, 1399/05/06
Update count:0
Registration date
2020-07-27, 1399/05/06
Registrant information
Name
mohammadtaghi koochaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3663 6813
Email address
mtkzf.ms@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-11, 1399/02/22
Expected recruitment end date
2020-06-11, 1399/03/22
Actual recruitment start date
2020-05-14, 1399/02/25
Actual recruitment end date
2020-06-11, 1399/03/22
Trial completion date
2020-06-26, 1399/04/06
Scientific title
Comparison of intravenous remifentanil and lidocaine on the cardiovascular response to laryngoscopy and tracheal intubation under general anesthesia in open limbs surgery.
Public title
Comparison of intravenous remifentanil and intravenous lidocaine in prevention of cardiovascular response following laryngoscopy and tracheal intubation under genereal anesthesia in limbs surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Open limbs surgery under general anesthesia
Class 1 and 2 of anesthesia risk (According to American society of anesthesiologist's classification),
Exclusion criteria:
Difficult intubation
prolonged ( more than 30 seconds) attempts at laryngoscopy
Repeated attempts at laryngoscopy
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
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple blind randomization Which consists of 60 completely identical sheets and is written in 30 sheets of the control group and 30 sheets of intervention and each patient is divided by removing one sheet and the sheet is left out.
Blinding (investigator's opinion)
Double blinded
Blinding description
60 identical small ball(30 intervension and 30 control) in a bag used for randomization,for each patient one ball randomly took by anesthetist. patient, researcher and data collector were unaware of patient group.
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
2020-05-09, 1399/02/20
Ethics committee reference number
IR.SHMU.REC.1399.042
Health conditions studied
1
Description of health condition studied
Open reduction and internal fixation of ulna and radius fracture
ICD-10 code
S52.4
ICD-10 code description
Fracture of shaft of radius
2
Description of health condition studied
Open reduction of humerus fracture
ICD-10 code
S42.4
ICD-10 code description
Fracture of lower end of humerus
3
Description of health condition studied
Open reduction of tibia fractures
ICD-10 code
S82.3
ICD-10 code description
Fracture of lower end of tibia
Primary outcomes
1
Description
Blood pressure
Timepoint
Before induction of anesthesia and just following laryngoscopy and tracheal intubation
Method of measurement
Non-invasive blood pressure measurement with Novin Saadat monitor.
2
Description
Pulse rate
Timepoint
Before induction of anesthesia and just following laryngoscopy and tracheal intubation
Method of measurement
Non-invasive blood pressure measurement with Novin Saadat monitor.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30of parcipitants that received remifentanil with a dose of 2µg/kg
Category
Treatment - Drugs
2
Description
Control group: A group of 30 people who received 1.5 micrograms per kilogram of lidocaine weight.
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 3901
Email
javadnourian@gmail.com
Web page address
http://shmu.ac.ir/emh/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
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
Grant name
Grant code / Reference number
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
Mtkzf.ms@gmail.com
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
javadnourian@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