Effect of single-dose intravenous dexamethasone on post operative hyperglycemia in non-diabetic patients undergoing abdominal hysterectomy versus control group at Moheb Yas Hospital in Tehran.
Design
This study will be a double-blind randomized clinical trial and patients will randomly divided into control and dexamethasone receiving groups, The sample size was 66 individuals based on analysis of variance of repeated measures, with 33 individuals in each group.
Settings and conduct
It's a double-blind randomized clinical trial (patient and anesthesiologist Will be unaware of the type of medication received) it will be performed at Moheb Yas Hospital in Tehran, women's candidates for abdominal hysterectomy with inclusion criteria will divide randomly into two groups of receiving dexamethasone and the control group who will receive a placebo. After surgery, blood glucose levels are monitored for 24 hours and the patient's nausea, vomiting and CRP levels are also monitored.
Participants/Inclusion and exclusion criteria
All non-diabetic 30-65-year-old women referring to Moheb Yas Hospital in Tehran at the designated time for elective abdominal hysterectomy and are ready to participate in this research project. Patients who have allergies, recent consumption of glucocorticoids, or contraindication of glucocorticoid, use of anti-nausea medications 24 hours before surgery, gastrointestinal disease, motion sickness, prior history of PONV, and patients that are under treatment with oral contraceptives or on hormone therapy during the pregnancy and smokers will be excluded.
Intervention groups
Patients receiving 8 mg dexamethasone intravenously immediately after induction of anesthesia and before surgical incision.
Main outcome variables
Blood glucose , nausea, vomiting,CRP level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120624010102N3
Registration date:2020-03-23, 1399/01/04
Registration timing:registered_while_recruiting
Last update:2020-03-23, 1399/01/04
Update count:0
Registration date
2020-03-23, 1399/01/04
Registrant information
Name
Ehsan Bastan hagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4204 6310
Email address
drbastanhagh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-15, 1398/10/25
Expected recruitment end date
2020-08-18, 1399/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of single dose intravenous Dexamethasone on postoperative blood glucose in non-diabetic patients undergoing abdominal hysterectomy
Public title
The effect of dexamethasone on postoperative blood glucose
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women
Aged 30 to 65 years
Non-diabetic
Abdominal hysterectomy candidate
Exclusion criteria:
Allergies
recent use of glucocorticoids
anti-nausea medication within 24 hours before surgery
gastrointestinal disease
motion sickness
oral contraceptives
hormone therapy
smokers
Age
From 30 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups using balanced block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
The study medications are prepared by an anesthesiologist who does not otherwise participated in the study and then enveloped and sealed and patient's code are recorded on it.The enveloped will open before induction by an anesthesiologist who is blinded to patient's study group and type of solution.All of the nurses and patient's are blinded to the type of solution and to the patient's study group allocation
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
5th flour, Corner of ghods St, Keshavarz Blv.
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۴۱۴۴۱۸
Approval date
2019-12-10, 1398/09/19
Ethics committee reference number
IR.TUMS.MEDICIN.REC.1398.658
Health conditions studied
1
Description of health condition studied
Evaluation of Dexamethasone effect of post operative nausea and vomiting in abdominal hysterectomy.
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
2
Description of health condition studied
Evaluation of glucose impairment by Dexamethasone injection after abdominal hysterectomy surgery.
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Blood sugar
Timepoint
Before surgery and 6, 12, 18 and 24 hours after surgery
Method of measurement
Glucometer
Secondary outcomes
1
Description
Nausea and vomiting and CRP
Timepoint
24 hours postoperative
Method of measurement
Asking and do the test
Intervention groups
1
Description
Intervention group: Intravenous injection of 8 mg dexamethasone immediately after induction of anesthesia and before surgical incision.
Category
Treatment - Drugs
2
Description
Control group: The same amount of normal saline will be injected
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas Hsopital
Full name of responsible person
Somayeh Mohammady
Street address
Yas Hospital, End of North Ostad Nejatolahi Ave.,Karimkhan Zand St,
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8899 5767
Fax
+98 21 4988 7128
Email
e-bastanhagh@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Somayeh Mohammady
Street address
No.1, North Nejatollahi Ave., Karimkhan St., Tehran,
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8899 5767
Email
somayehmohamady777@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Somayeh Mohamady
Position
Resident of anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
North Nejatollahi Ave., KarimKhan Zand St.
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8899 5767
Email
somayehmohamady777@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Somayeh Mohammady
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Yas hospital,Nejatollahi Ave., Karimkhan zand St.
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8899 5767
Email
somayehmohamady777@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Somayeh Mohammady
Position
Resident of anestesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Yas hospital Karimkhan zand sreet
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8899 5767
Email
somayehmohamady777@gmail.com
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