The objective of this randomized, double blind mono center trial is to investigate the effect of IV Dexamethasone on Alfentanil-induced cough. In this study, 80 patients aged 18-50 years old, with physical status 1, 2 ASA and elective surgery, under general anesthesia and premed IV alfentanyl will be recruited and randomly assigned into intervention or control group. The patients in the intervention group will receive 0.15 mg/kg of I.V. Dexamethasone (2 ml), five minutes before anesthesia induction and Alfentanyl injection. The patients in the control group will also receive placebo (Normal saline) with same volume. The number of coughs will be measured during 30 seconds after alfentanyl injection and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111141083N6
Registration date:2011-12-08, 1390/09/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-08, 1390/09/17
Registrant information
Name
Majid Pourshaikhian
Name of organization / entity
Guilan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 13 3360 5768
Email address
m_pourshaikhan@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2008-04-03, 1387/01/15
Expected recruitment end date
2009-03-18, 1387/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous Dexamethasone in diminishing Alfentanil-induced cough
Public title
Effect of Dexamethasone on cough
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Elective surgery, general anesthesia, age 18-50 years old, 30-90kg, physical status: ASA 1 and 2
Exclusion criteria: Previous Asthma, smoking, chronic cough, use of bronchodilator, antihistamine, steroid, anti-cough, infection of upper respiratory system
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ardabil University of Medical Sciences and Health Services
Street address
Ardabil University of Medical Science, Justice administration side- Shorabil-way of University- Ardabil
City
Ardabil
Postal code
56191
Approval date
2008-02-27, 1386/12/08
Ethics committee reference number
2533/2/2/پ
Health conditions studied
1
Description of health condition studied
General anesthesia
ICD-10 code
T88.8
ICD-10 code description
Other specified complications of surgical and medical care, not elsewhere classified
Primary outcomes
1
Description
cough
Timepoint
Injection of Alfentanyl 5 minutes after injection of Dexamethasone (intervention), then counted the numbers of cough during 30 seconds.
Method of measurement
Observation of patient and counting of cough
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
IV Injection of single dose Dexamethasone, 0/15 mg/kg (2 ml ), 5 minutes before alfentanyl injection
Category
Treatment - Drugs
2
Description
Control group:
IV Inection of distilled water (2) ml, five (5) minutes before alfentanyl injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi hospital
Full name of responsible person
Dr Vadod Norouzi (Anethesiologist, Ardabil University professor)
Street address
Dr Fatemi hospital- Shariati square-Emam Khomaini Avenue- Ardabil- Iran
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Private
Full name of responsible person
Vadod Norouzi (professor of anesthesia)
Street address
Dr Fatemi hospital- Emam khomaini Avenue- Ardabil -
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Private
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
Guilan University of Medical Sciences and Health Services
Full name of responsible person
Majid Pourshaikhian
Position
MSc of Anesthesia
Other areas of specialty/work
Street address
No.19, 24 metri keshavarz Ave., Shahid Beheshti street, Rasht,