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Effect of Premedication with Methylprednisolon or Dexamethason in Severity of Pain after Infusion of Propofol.

Protocol summary

Study aim
Effect of premedication with methylprednisolon and Dexamethason will be evaluated on post injectional pain of propofol.
Design
Sampling is done by continuous method and to come in order of patients. First, an 18 guage intravenous cannula will be embedded on vein of dorsal of hand. Patients are divided to three groups consist on M (methylprednisolon), D (dexamethason) and NS (normal saline). This study is a randomized, double blind clinical trial with control group. Sample size of this study is 120 cases.
Settings and conduct
This study is performed in Emam Reza hospital in Tabriz. After embedding of venous catheter and hold up upper limb to 15 seconds, the tornike to close forearm. In the NS group, 5 mililiter normal saline, M group, 125 miligram in 5 mililiter volume with normal saline and D group, 0.25 or 0.5 miligram per kilogram in 5 mililiter volume with normal saline, will be injected. After 30 seconds, the tornike will be opened and 5 mililiter propofol 1% will be injected in 15 seconds. Then, two anesthsiologist will be calculated rate of pain by 4 number verbal rating scale that presented by McCriffick and measurement Rochette criteria in 5, 10,15 and 20 seconds after propofol injection. Patients and two anesthsiologist will be blindfolding.
Participants/Inclusion and exclusion criteria
Enterance: Patients under elective surgery, I and II ASA Class, between 15 to 65 years old; Exit: Patients with cardiovascular, hepatic, renal and psychiatric disease, need for RSI of anesthesia and using sedative drugs in the last 24 hours.
Intervention groups
Three interventional groups are patients under injection of Methylprednisolon, Dexamethasone and Normal Saline.
Main outcome variables
Primary event: incidence of moderate to severe pain after propofol injection. Secondary event: decrease post injectional pain of propofol after premedication with methylprednisolon and dexamethasone.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150125020795N6
Registration date: 2019-11-09, 1398/08/18
Registration timing: registered_while_recruiting

Last update: 2019-11-09, 1398/08/18
Update count: 0
Registration date
2019-11-09, 1398/08/18
Registrant information
Name
Samad Golzari
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3556 6183
Email address
golzaris@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Premedication with Methylprednisolon or Dexamethason in Severity of Pain after Infusion of Propofol.
Public title
Effect of Premedication with Methylprednisolon or Dexamethason in Severity of Pain after Infusion of Propofol.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All of Patients who Being a Candidate for Elective Surgery and Based on ASA Classification are 1 or 2 ASA Class
Exclusion criteria:
Patients with Cardiovascular, Hepatic and Kidney Disease. Need for Rapid Sequence Induction of Anesthesia. Patients with Psychiatric Disorders. Patients under Prescription of Sedative Drugs in the last 24 hours.
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling is done by easy burst method and according to patient referral to operating room. Randomization method is pre and post accidental blocks and will be done by Randlist software.
Blinding (investigator's opinion)
Double blinded
Blinding description
All of Patients do not Know about used Drugs in this Study. Two Anesthesiologist who evaluated clinical response to administerated drugs.
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
Faculity of Medicine, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-07-03, 1398/04/12
Ethics committee reference number
IR.TBZMED.REC.1398.391

Health conditions studied

1

Description of health condition studied
Post Injectional Pain of Propofol
ICD-10 code
T88.59
ICD-10 code description
Other complications of anesthesia

Primary outcomes

1

Description
Post injectional pain of propofol
Timepoint
Amount of pain evaluate on 5, 10, 15 and 20 seconds after injection of propofol.
Method of measurement
Four Numerical Verbal Rating Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients will be injected 125 milligram Methylprednisolon in 5 milliliter total volume with normal saline.
Category
Treatment - Other

2

Description
Intervention group: Patients will be injected 0.25 or 0.5 milligram Dexamethasone per kilogram of body weight in 5 milliliter total volume that diluted by normal saline.
Category
Treatment - Other

3

Description
Control group: Patients will be injected by 5 milliliter of normal saline.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Samad Eslaam Jamal Golzari
Street address
Department of Anesthesiology, Faculty of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Email
golzaris@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Dr Abolghasem Joyban
Street address
Vice chancellor for research, ِDaneshgah street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
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 of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Departement of Anesthesiology, Faculty of Medicine, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Email
golzaris@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Faculty of Medicine, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Email
golzaris@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Faculty of Medicine, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Email
golzaris@tbzmed.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
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