Protocol summary

Summary
The main idea of study is to evaluate the effect of preoperative intravenous Dexamethasone on voice change after thyroidectomy. We designed a double blind randomized clinical trial. Patients with total thyroidectomy are enrolled. Exclusion criteria are reoperation and preoperative voice change. Patients are randomized into two groups. For each patient two questionnaires will be filled. One questionnaire contains demographic data, thyroid pathology, thyroid weight, wound infection and healing rate and blood glucose level on days one and seven after surgery. The other questionnaire is for voice change containing 10 questions each scoring 0-4 which will be filled by patients preoperatively and on days one and seven after surgery. After inform consent, one hour before surgery, one group will receive 8 mg (2 cc) Dexamethasone intravenously and the other group will receive 2 cc normal saline as placebo. The Information will be analyzed by SPSS and voice change will be compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201106306925N1
Registration date: 2012-02-18, 1390/11/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-02-18, 1390/11/29
Registrant information
Name
Shirzad Nasiri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2450
Email address
nasiri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2012-06-20, 1391/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of preoperative intravenous Dexamethasone on voice change after total thyroidectomy
Public title
Effect of Dexamethasone on voice change after total thyroidectomy
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: total thyroidectomy patients exclusion criteria: prior operation; voice change preoperativly
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 66
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
Tehran University of Medical Sciences Ethics Committee
Street address
6 th floor, central building of Tehran University of Medical Sciences, Gods st., Keshavarz ave.
City
Tehran
Postal code
Approval date
2011-06-19, 1390/03/29
Ethics committee reference number
130/1313/د

Health conditions studied

1

Description of health condition studied
total thyroidecyomy
ICD-10 code
Y83.6
ICD-10 code description
Removal of other organ (partial) (total)

Primary outcomes

1

Description
voice change
Timepoint
Befor operation and 1 and 7 days after surgery
Method of measurement
quetionnaire

Secondary outcomes

1

Description
wound infection
Timepoint
1 st and 7 th days after surgery
Method of measurement
Physical examination

2

Description
Blood glucose level
Timepoint
1 st and 7 th days after surgery
Method of measurement
Lab analysis

Intervention groups

1

Description
8 mg of dexamethasone inrtavenously befor induction of anesthesia.
Category
Treatment - Drugs

2

Description
2 cc of normal salin intravenously befor induction of anesthesia
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital, general surgery ward
Full name of responsible person
Dr. Shima Shafag
Street address
General surgery ward, Shariati Hospital, North Kargar st.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Fotuhi
Street address
Tehran University of Medical Sciences building,Gods st., Keshavarz ave.
City
Tehran
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, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Shima Shafag
Position
General surgery resident
Other areas of specialty/work
Street address
Shariati Hospital, North Kargar st.
City
Tehran
Postal code
Phone
+98 21 8490 2450
Fax
Email
shafagh824@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shirzad Nasiri
Position
Assistant professor of surgery
Other areas of specialty/work
Street address
Shariati Hospital, North Kargar st.
City
Tehran
Postal code
Phone
+98 21 8490 2450
Fax
Email
nasiri@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran Univesity of Medical Sciences, Shariati Hospital
Full name of responsible person
Shima Shafag
Position
General surgery resident
Other areas of specialty/work
Street address
General surgery ward, Shariati Hospital, North Kargar st.
City
Tehran
Postal code
Phone
+98 21 8490 2450
Fax
Email
shafagh824@yahoo.com
Web page address

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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