Protocol summary

Summary
The aim of the study is comparing efficacy of the Lidocaine and Lidocaine with Nitroglycerin for reducing Poropofol induced pain during induction of anesthesia. In a Clinical trial study Ninety Patients randomly were enrolled to study in three equal groups. Main Inclusion criteria are ASA Class I-II, range of 15-60 years of old and exclusion criteria are Heart block, previous analgesic consumption, psychopathic disorder, kidney and liver disorder. Before induction of anesthesia noninvasive blood presser cuff fastened around vein access arm and inflated to reach 200mmHg, then first group received intravenous Lidocaine 20 mg 2%, second group received Lidocaine 20 mg 2% in addition to Nitroglycerine 0.1mic/kg but third group did not received any drugs before injection of 20 percent of calculated Propofol dose. After one minute cuff deflated and 20 percent of calculated Propofol dose injected. Finally main outcome (pain) induced by Propofol injection recorded according visual analogue scale before overcoming unconciseness .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201308274005N6
Registration date: 2014-08-02, 1393/05/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-08-02, 1393/05/11
Registrant information
Name
Khosro Kolahdouzan
Name of organization / entity
Faculty of Paramedical Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 4777
Email address
kolahdozank@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-09-11, 1392/06/20
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of lidocaine compared with lidocaine plus nitroglycerin in the reducing of poropofol pain injection in anesthesia induction
Public title
pevention of poropofol induced pain during anesthesia induction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA Class I-II; range of 15-60 years of old Exclusion criteria:Heart block; previous analgesic consumption; psychopathic disorder; kidney and liverdisorder
Age
From 15 years old to 60 years old
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht street, Azadi avenue
City
Tabriz
Postal code
Approval date
2013-07-07, 1392/04/16
Ethics committee reference number
9282

2

Ethics committee
Name of ethics committee
Tabriz University of Medical Science
Street address
Deputy of Research and Technology,third flour,Central Building No 2,Tabriz University of Medical Science,Golgasht street,Tabriz
City
Tabriz
Postal code
Approval date
2013-07-07, 1392/04/16
Ethics committee reference number
9282

Health conditions studied

1

Description of health condition studied
Pain due to injection of propofol
ICD-10 code
T88.7
ICD-10 code description
Unspecified adverse effect of drug or medicament

Primary outcomes

1

Description
Pain
Timepoint
Pain during Propoful injection
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Reducing of pain
Timepoint
After injection of lidocaine or lidocaine/nitroglycerine
Method of measurement
visual analogue scale

Intervention groups

1

Description
After inflation of blood pressure Cuff, in first group 20 mg Lidocaine before injection of Propofol injected. After one minute 20% of calculated Propofol injected and score of pain was measured
Category
Treatment - Drugs

2

Description
After inflation of blood pressure Cuff, second group 20mg Lidocaine in addition to 0/1microgram/kg Nitroglycerine injected. After one minute 20% of calculated Propofol injected and score of pain was measured
Category
Treatment - Drugs

3

Description
One minute after inflation of blood pressure Cuff in third group 20% of calculated Propofol injected and score of pain was measured
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital/Tabriz
Full name of responsible person
ِDawood Aghamohammadi
Street address
Tabriz Emam Reza hospital, Golgasht street, Azadi avenue
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Rashidi
Street address
Tabriz University of Medical Sciences, Golgasht street, Azadi avenue
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Dawood aghamohammadi
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
City
Tabriz
Postal code
Phone
+98 41 1335 7313
Fax
+98 41 1334 1994
Email
aghamohammadid@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dawood Aghamohammadi
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht street, Azadi street
City
Tabriz
Postal code
Phone
+98 41 1335 7313
Fax
+98 41 1334 1994
Email
aghamohammadid@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir

Person responsible for updating data

Contact

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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