1. Home
  2. Approved trials
  3. » فارسی

 Evaluation Of Mexiletine Effect On BIS Index Change &Hemodynamic Responses To Endotracheal Intubation &During General Anesthesia in upper limbs surgeries

Protocol summary

Summary
By many Researches it has been shown that painful stimulations during laryngoscopy and intubation not only increases Bp,HR of the patients but also BIS index. One of the ways to decrease these changes,is using drugs either as premedications or during anaesthesia induction.one of the drugs of this group is Lidocaine and by some researches its proved that this drug has a great role on decreasing the changes of haemodynamic status and BIS index of the patients. By our research the haemodynamic and BIS index changes are studied after intubation and during general anaesthesia with using Mexiletine Inclusion Criteria:Patients scheduled for upper limb orthopedic surgery under G.A with A.S.A 1,2,aged 20-60 yrs.Exclusion Criteria:Liver disorders,positive history of sensitivity to local anesthetic drugs,bradycardia ,pregnant and neursing women, seizure disorders,C.N.S problems and heart blocks.50 patients(between the ranges of 20-60 yrs) are divided randomly in 2 groups.2 hours before inducing anaesthesia,Mexiletine(200mg/po) is taken by the case group and Multivitamin by the control group.BP,HR and BIS index of both groups are measured before induction and intubation,1,3,10 minutes after intubation,after incision of the surgery and then every 15 minutes till the end of the operation and finally the results are compared with each others.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201109067488N1
Registration date: 2012-12-28, 1391/10/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-12-28, 1391/10/08
Registrant information
Name
Mohammadali Haghbin
Name of organization / entity
Kerman University of MedicalSciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 5814
Email address
m.a.haghbin@gmail.com
Recruitment status
Recruitment complete
Funding source
kerman university of medical sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
 Evaluation Of Mexiletine Effect On BIS Index Change &Hemodynamic Responses To Endotracheal Intubation &During General Anesthesia in upper limbs surgeries
Public title
Effect of Mexiletine on depth of anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:Patients scheduled for upper limb orthopedic surgery under G.A with A.S.A 1,2,aged 20-60 yrs.Exclusion Criteria:Liver disorders,positive history of sensitivity to local anesthetic drugs,bradycardia ,pregnant and neursing women, seizure disorders,C.N.S problems and heart blocks . patients in whom more than 15 sec were required for tracheal intubation were excluded from the study
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
kerman University of Medical Sciences
Street address
Jomhoori street
City
kerman
Postal code
Approval date
2012-05-19, 1391/02/30
Ethics committee reference number
91/57/کا

2

Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
Jomhoori street
City
Kerman
Postal code
Approval date
2012-05-19, 1391/02/30
Ethics committee reference number
91/57/کا

Health conditions studied

1

Description of health condition studied
B.I.Sindex,B.P,H.R
ICD-10 code
S40-S41_S4
ICD-10 code description
Injuries to upper extrimity

Primary outcomes

1

Description
B.I.S index
Timepoint
Before and 3 minutes after induction of anesthesia and 1,3.10minutes after intubation ,incision of surgery and every 15 minutes till the end of operation.
Method of measurement
monitoring of depth of anesthesia

2

Description
Systolic Blood pressur
Timepoint
Before and 3 minutes after induction of anesthesia and 1,3.10minutes after intubation ,incision of surgery and every 15 minutes till the end of operation.
Method of measurement
mmhg by NIBP Monitoring

3

Description
Diastolic Blood pressur
Timepoint
Before and 3 minutes after induction of anesthesia and 1,3.10minutes after intubation ,incision of surgery and every 15 minutes till the end of operation.
Method of measurement
mmgh by NIBP manitoring

4

Description
Heart Rate
Timepoint
Before and 3 minutes after induction of anesthesia and 1,3.10minutes after intubation ,incision of surgery and every 15 minutes till the end of operation.
Method of measurement
Heart Rate by electronic monitoring

Secondary outcomes

empty

Intervention groups

1

Description
Case group: Mexiletine Cap 200 mg , 2hours before operation
Category
Treatment - Drugs

2

Description
control group :Multivitamin Cap ,2hours before operation
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
[Orthopedic Operating Room of Bahonar Hospital
Full name of responsible person
Dr Mohammad Ali Haghbin
Street address
General Operating room Of Shafa Hospital
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Faranak khezri
Street address
Jomhoori street
City
kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical sciences
Full name of responsible person
Dr Mohammad Ali Haghbin
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
General Operating Room Of Shafa Hospital
City
kerman
Postal code
Phone
+98 34 1211 5780
Fax
Email
m.a.haghbin@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Haghbin
Position
Assisstan Professor of Anesthesia
Other areas of specialty/work
Street address
General operating room of Shafa Hospital
City
kerman
Postal code
Phone
+98 341
Fax
Email
m.a.haghbin@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Haghbin
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Shafa Hospital
City
Kerman
Postal code
Phone
00
Fax
Email
m.a.haghbin@gmail.com
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...