Protocol summary

Summary
This study aims to focus on effect of perioperative intravenous dexamethasone on hypocalcemia after total thyroidectomy. In prospective randomized unblinded study, 90 subjects who needs total thyroidectomy is entered. They divided in two groups: 45 patients receive 8mg Dexamethasone 90 minutes before surgery as case groups and 45 patients do not as control group. patients with age range 18-70 years who need total thyroidectomy are included. Patients who have History of corticoesteroid consumption in past three months are excluded.Hypocalcemia is compared after surgery in both.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017011329726N3
Registration date: 2017-02-10, 1395/11/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-10, 1395/11/22
Registrant information
Name
Mohsen Kolahdouzan
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 2277
Email address
kolahdouzan@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of perioperative intravenous dexamethasone on hypocalcemia after total thyroidectomy in patients who candidate for thyroidectomy
Public title
Effect of perioperative intravenous dexamethasone on hypocalcemia after total thyroidectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age range 18-70 years; needed total thyroidectomy; tendency for participation in the study Exclusion criteria: diabetic patients; history of ischemic heart disease; hypertensive patients; History of corticoesteroid consumption in past three months; pregnancy; addiction; expired patients during study; any changes in thyroidectomy types
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
None
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Isfahan University of Medical Sciences
Street address
Floor 2, Office of Deputy President, Isfahan, Isfahan University of Medical Sciences, Hezarjarib Ave,
City
Isfahan
Postal code
8174673461
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
393921

Health conditions studied

1

Description of health condition studied
Hypocalcemia
ICD-10 code
E89.2
ICD-10 code description
Other postprocedural endocrine and metabolic disorders

Primary outcomes

1

Description
serum Ca Level
Timepoint
6 and 24 hours after surgery
Method of measurement
Blood sampling

2

Description
Serum PTH level
Timepoint
6 and 24 hours after surgery
Method of measurement
Blood sampling

Secondary outcomes

1

Description
Clinical symptomes of Hypocalcemia
Timepoint
Two weeks after surgery
Method of measurement
History taking and physical examination

Intervention groups

1

Description
Case group: receive Dexamethasone 8mg 90 minutes before total thyroidectomy
Category
Prevention

2

Description
Control Group: without Dexamethasone before thyroidectomy
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Mohsen Kolahdouzan
Street address
Surgery Department, Alzahra Hospital, Soffeh Avenue, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mehdi Nematbakhsh
Street address
Vice chancellor for Research, Soffeh Avanue, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Mohsen Kolahdouzan
Position
Faculty Member
Other areas of specialty/work
Street address
Surgery Department, Alzahra Hospital, Soffeh Avanue, Isfahan,
City
Isfahan
Postal code
Phone
+98 31 3620 2020
Fax
Email
kolahdouzan@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohsen Kolahdouzan
Position
Faculty member
Other areas of specialty/work
Street address
Surgery Department, Alzahra Hospital, Soffeh Avanue, Isfahan,
City
Isfahan
Postal code
Phone
+98 31 3620 2020
Fax
Email
kolahdouzan@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohsen Kolahdouzan
Position
Faculty Member
Other areas of specialty/work
Street address
Surgery Department, Alzahra Hospital, Soffeh Avenue, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 3620 2020
Fax
Email
kolahdouzan@med.mui.ac.ir
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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