(1) Objective: Comparison of pre-operative Dexamethasone and Petidine on shivering following general anesthesia in minor urologic surgeries (2) Design: Interventional, Randomized, Double blind, Without placebo, Unicentral (3) Population and Sampling: 120 patient 25-50 years old (60 in the Dexamethasone group and 60 in the Pethidine group) who were candidate for urologic outpatient surgery
(4 )Inclusion criteria: Patients with physical status ASA I or II; Undergoing outpatient urologic procedures (Hydrocele, Hernia, Varicoscele); By general anesthesia
Exclusion criteria: Patients with history of Hypertension; Diabetes; Gastric ulcer; Massive transfusion; Prolong treatment with corticosteroids
(5) Intervention: After premedication with intravenous Midazolam 0.15 milligrams per kilogram and Lidocain 1 milligram per kilogram and Fentanyl 1 microgram per kilogram and before induction of anesthesia; in group D, 8 milligrams intravenous Dexamethasone and in group P, 25 milligrams intravenous Pethidin were injected
(6) Main outcome: Post-operative shivering were evaluated using the stated scoring after one hour post-operative.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308284005N8
Registration date:2014-11-15, 1393/08/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-15, 1393/08/24
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
Tabriz University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pre-operative Dexamethasone and Petidine on shivering following general anesthesia in minor urologic surgery
Public title
Comparison of pre-operative Dexamethasone and Petidine on shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with physical status ASA I or II; undergoing outpatient urologic procedures (Varicoscele, Hydrocele, Hernia); aged 25-50 years
Exclusion criteria: Patients with history of Hypertension; Diabetes; Gastric ulcer; Massive transfusion; Prolong treatment with corticosteroids
Age
From 25 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Tabriz University of Medical Sciences
Street address
Emam Reza Hospital, Golgasht Street, Azadi Avenue
City
Tabriz
Postal code
Approval date
2013-12-18, 1392/09/27
Ethics committee reference number
92156
Health conditions studied
1
Description of health condition studied
Postoperative shivering
ICD-10 code
T88.5
ICD-10 code description
Other complication of anesthesia
Primary outcomes
1
Description
Shivering
Timepoint
Every 10 minute for 1 hour
Method of measurement
Standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
After premedication with intravenous Midazolam 0.15mg/kg and Lidocain 1 mg/kg and Fentanyl 1 µg/kg and before induction of anesthesia, in first group( D), intravenous Dexamethasone 8mg injected and shivering was evaluated after one hour post-operative.
Category
Treatment - Drugs
2
Description
After premedication with intravenous Midazolam 0.15mg/kg and Lidocain 1 mg/kg and Fentanyl 1 µg/kg and before induction of anesthesia, in second group( P), pethidin 8 mg IV injected and shivering was evaluated after one hour post-operative
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Mahmoud Eidy
Street address
Emam Reza Hospital, Golgasht Street, Azadi Avenue
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Soleimanpoor
Street address
Research Assistant
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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. Mahmoud Eidy
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Emam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 3334 1994
Fax
Email
eidym@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
Dr. Mahmoud Eidy
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Emam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 3334 1994
Fax
Email
eidym@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)