Protocol summary

Summary
The purpose of this research is to find the best drugs in intubation that have the least side effects. This is a simple nonrandomized, double- blind clinical trial in patients who needed emergency intubation in Edalatian emergency center, Imam Reza Hospital, Mashhad University of Medical Sciences. All patients requiring endoteracheal intubation, and those who do not demonstrate sensitivity towards lidocaine consumption, are included in this study. Exclusion criteria include: predetermined senstiivity to fentanyl; crash intubation; difficult intubation. The patients were divided into 3 group, each with a sample size of 30 participants. The control group (M) were injected with 3μgr/kg IV fentanyl and 1.5 mg/kg IV lidocaine.group ( f ) were given 3μgr/kg IV fentanyl and group (L) were given1.5 mg/kg IV lidocain. Heart rate and mean arterial pressure were assessed 4 times: before intubation, excatly after intubation, 5 and 10 minutes after intubation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016121514872N5
Registration date: 2017-06-25, 1396/04/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-25, 1396/04/04
Registrant information
Name
Mohammad Davood Sharifi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5312
Email address
sharifimd@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation through effects of intravenous lidocaine and fentanyl on hemodynamic responses after intubation
Public title
Investigation through effects of intravenous lidocaine and fentanyl on hemodynamic responses after intubation
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: All patients who need endoteracheal intubation; insensitivity to lidocaine exclusion criteria: predetermined senstiivity to fentanyl; crash intubation; difficult intubation
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Daneshgah street, Ghoreishi building
City
Mashhad
Postal code
Approval date
2014-11-08, 1393/08/17
Ethics committee reference number
930268

Health conditions studied

1

Description of health condition studied
adverse effect of intubation
ICD-10 code
T88.7
ICD-10 code description
Unspecified adverse effect of drug or medicament

Primary outcomes

1

Description
Heart Rate
Timepoint
Before intubation, 0 and 5 and 10 minutes after intubation
Method of measurement
Cardiac monitoring

2

Description
Mean Arterial Pressure
Timepoint
Before intubation, 0 and 5 and 10 minutes after intubation
Method of measurement
Mean Arterial Pressure with cardiac monitoring device

Secondary outcomes

empty

Intervention groups

1

Description
Control group: They were injected with 3 μgr/kg IV fentanyl and 1.5 mg/kg IV lidocaine
Category
Prevention

2

Description
Intervention group: In this group, participants were injected with 3 μgr/kg IV fentanyl.
Category
Prevention

3

Description
Intervention group: In this group, participants were injected with 1.5 mgr/kg IV lidocaine.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Mohammad Davood Sharifi
Street address
Edalatian Emergency Center, Imam Reza Hospital, Imam Reza Square, Mashhad, Iran
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Saeid Eslami
Street address
Ghoreishi building, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Davood Sharifi
Position
associate professor
Other areas of specialty/work
Street address
Edalatian emergency, Imam Reza hospital
City
Mashhad
Postal code
Phone
+98 51 3852 5312
Fax
Email
SHARIFIMD@MUMS.AC.IR
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Davood Sharifi
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Edalatian emergency, Imam Reza hospital
City
Mashhad
Postal code
Phone
+98 51 3852 5312
Fax
Email
Sharifimd@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Davood Sharifi
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Edalatian Emergency Center, Emam Reza hospital, Emam Reza Square, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3852 5312
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...