Comparison of Agitation in recovery after mastectomy in patients receiving dexamethasone in comparison with placebo in Imam Khomeini Hospital Operating room, 1391-1392
The objective of this double-blinded randomized control trial was to evaluate the efficacy of dexamethasone versus placebo in preventing post-operative agitation in 116 patients who underwent mastectomy. The inclusion criterion was being 18-65 years old. In this study, patients were randomized to two groups; the first group (dexamethasone group) was treated with 8 milligrams of intravenous dexamethasone and the second group (placebo group) was assigned to 2 milliliters of sterile water after induction of anesthesia and before intubation. During recovery patients were evaluated for incidence and severity of agitation, severity of pain, occurrence of nausea and vomiting and degree of somnolence after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306139213N2
Registration date:2014-01-08, 1392/10/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-08, 1392/10/18
Registrant information
Name
Jalil Makarem
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1576
Email address
j-makarem@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Because the drugs were routinely used for anesthesia, the patient is responsible for project cost ,it includes his medical expenses
Expected recruitment start date
2012-09-19, 1391/06/29
Expected recruitment end date
2013-12-31, 1392/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Agitation in recovery after mastectomy in patients receiving dexamethasone in comparison with placebo in Imam Khomeini Hospital Operating room, 1391-1392
Public title
Comparison of Agitation in recovery after mastectomy in patients receiving dexamethasone in comparison with placebo in Imam Khomeini Hospital Operating room, 1391-1392
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1. aged between 18 and 65 years
2. mastectomy surgery
Exclusion criteria:
1. antiemetic consumption after surgery
2. a positive history of psychiatric or CNS disorders
3. having diabetics or uncontrolled blood pressure
4. analgesic consumption before surgery
5. a history of substance abuse consuming or other medications
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
104
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
Tehran University of Medical Sciences, Qods Street, Keshavarz Blvd , Tehran
City
Tehran
Postal code
Approval date
2013-08-04, 1392/05/13
Ethics committee reference number
899/130/د/92
Health conditions studied
1
Description of health condition studied
agitation
ICD-10 code
R45.1
ICD-10 code description
Restlessness and agitation
Primary outcomes
1
Description
agitation
Timepoint
10 minutes after transfer to recovery room
Method of measurement
By applying the standard RASS questionnaire (attached) post-anesthesia agitation is assessed 10 minutes after transfer to recovery room. This questionnaire consists of 10 levels (from +4 to -5) in which values more than +1 are considered emergent delirium or agitation per se.
Secondary outcomes
empty
Intervention groups
1
Description
Group 1 placebo: 2 milliliters sterile water, IV during 30 seconds
Category
Prevention
2
Description
Group 2, dexamethasone group: 8 milligrams dexamethasone, IV, post-induction and pre-intubation, during 30 seconds
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Jalil Makarem
Street address
Tehran University of Medical Sciences, Poursina st, 16th Azar st, Enghelab eslami square, Tehran
City
Tehran
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
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
Dr.Jalil Makarem
Position
Assistant Professor
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Poursina st, 16th Azar st, Enghelab eslami square, Tehran
City
Tehran
Postal code
Phone
+98 21 6658 1576
Fax
Email
makaremj@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
Dr.Jalil Makarem
Position
Assistant Professor
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Poursina st, 16th Azar st, Enghelab eslami square, Tehran
City
Tehran
Postal code
Phone
+98 21 6658 1576
Fax
Email
makaremj@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Jalil Makarem
Position
Assistant Professor
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Poursina st, 16th Azar st, Enghelab eslami square, Tehran
City
Tehran
Postal code
Phone
+98 21 6658 1576
Fax
Email
makaremj@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)