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Comparing the effect of Alfentanil, Lidocaine, and combination of Alfentanil plus Lidocaine to control hemodynamic responses during awake extubation

Protocol summary

Summary
The aim of this study is to compare the effect of Alfentanil, Lidocaine and combination of Alfentanil plus Lidocaine to control hemodynamic responses during awake extubation.Inclusion criteria are upper limb orthopedic surgery and age between 20 - 40 years old. Exclusion criteria are smoking, addiction, cardiac respiratory disease, age less than 20, age more than 40 and drug allergy. 172 patients , divide into four equal groups. Group A; receives Alfentanil 5 microgram per kilogram, group B; receives Lidocaine 1 milligram per kilogram, group C; receives Alfentanil plus Lidocaine, and group D; receives normal saline. The mean systolic blood pressure, mean diastolic blood pressure, mean arterial pressure and heart rate measure and record before extubation and during extubation. Also, it measures and records 1, 5, 10, 15, and 20 minutes after extubation, bucking statue after extubation is recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016040725095N1
Registration date: 2016-04-07, 1395/01/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-07, 1395/01/19
Registrant information
Name
Mahmoud Aghaziarati
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3369 6076
Email address
m.aghaziarati@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2015-01-20, 1393/10/30
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Alfentanil, Lidocaine, and combination of Alfentanil plus Lidocaine to control hemodynamic responses during awake extubation
Public title
Comparing the effect of Alfentanil, Lidocaine, and combination of Alfentanil plus Lidocaine to control hemodynamic responses during awake extubation
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Having upper limb orthopedic surgery; age between 20 - 40 years Exclusion criteria: smoking; addiction; cardiac respiratory disease; age less than 20; age more than 40; drug allergy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 172
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
Ethics Committee of the University of Medical Sciences
Street address
Qazvin, Shahid Bahonar Boulvar
City
Qazvin
Postal code
3419915315
Approval date
2014-12-31, 1393/10/10
Ethics committee reference number
9674/20/28

Health conditions studied

1

Description of health condition studied
Hemodynamic changs after extubation
ICD-10 code
T88.9
ICD-10 code description
Complication of surgical and medical care, unspecified

Primary outcomes

1

Description
mean systolic blood pressure (SBP)
Timepoint
before and during extubation and, 1, 5, 15, and 20 minutes after extubation
Method of measurement
check list

2

Description
mean diastolic blood pressure (DBP)
Timepoint
before and during extubation and, 1, 5, 15, and 20 minutes after extubation
Method of measurement
check list

3

Description
mean artetial pressure
Timepoint
before and during extubation and, 1, 5, 15, and 20 minutes after extubation
Method of measurement
check list

4

Description
heart rate
Timepoint
before and during extubation and, 1, 5, 15, and 20 minutes after extubation
Method of measurement
chec list

Secondary outcomes

1

Description
bucking
Timepoint
after extubation
Method of measurement
check list

Intervention groups

1

Description
Group A received Alfentanil 5 µg/kg on reverse injection time
Category
Treatment - Drugs

2

Description
Group B received Lidocaine 1mg/kg on reverse injection time
Category
Treatment - Drugs

3

Description
Group C received Alfentani5 µg/kg plus Lidocaine1mg/kg on reverse injection time
Category
Treatment - Drugs

4

Description
Group d received normal saline on reverse injection time
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sgahid Rajaei Hospita of Qazvin
Full name of responsible person
Dr Mahmood Aghaziarati
Street address
Rajaei Hospital, Padegan Street, Qazvin
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Marzie Beighom Khezri
Street address
Shahid Bahonar Boulvar, Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr Mahmood Aghaziarati
Position
Anesthesia Assistant
Other areas of specialty/work
Street address
No 9, 22 Nargess Alley, Qaem Street, Amirkabir Boulvar, Poonak, Qazvin
City
Qazvin
Postal code
3414951474
Phone
+98 28 3369 6076
Fax
Email
mziarati1970@gmail mziarati1970@yahoo.com
Web page address
Hosrajaee@qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Mahmood Aghaziarati
Position
Anesthesia Assistant
Other areas of specialty/work
Street address
No 9, 22 Nargess Alley, Qaem Street, Amirkabir Boulvar, Poonak, Qazvin
City
Qazvin
Postal code
3414951474
Phone
+98 28 3369 6076
Fax
Email
mziarati1970@gmail mziarati1970@yahoo.com
Web page address
Hosrajaee@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Mahmood Aghaziarati
Position
Anesthesia Assistant
Other areas of specialty/work
Street address
No 9, 22 Nargess Alley, Qaem Street, Amirkabir Boulvar, Poonak, Qazvin
City
Qazvin
Postal code
3414951474
Phone
+98 28 3369 6076
Fax
Email
mziarati1970@gmail mziarati1970@yahoo.com
Web page address
Hosrajaee@qums.ac.ir

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
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