Recently most of laparoscopic surgeries especially gynecologic procedures are performed in an outpatient basis and early discharge of these patients without any significant complication is very important. One of the most common causes of late discharge or even admission of ambulatory surgeries is postoperative nausea and vomiting. The aim of this study is to assess the efficacy of antiemetic for prevention of postoperative nausea and vomiting. Following approval from the Local Ethics Committee and receipt of written informed consent, 105 ASA physical status I-II patients who underwent diagnostic laparoscopy will be enrolled into the study in three groups. General anesthesia will be standardized. The patients in group 1 will be receive 8mg Dexamethasone before induction of anesthesia,Group 2 will be receive 4mg Ondansetron IV before the end of surgery and group 3 will be received dexamethasone plus ondansetron as the same doses and ways. Nausea-vomiting will be evaluated with Bellville score and patients will be taken antiemetic (10mg Metoclopramide IV)for scores of 2 or 3.besides,the incidence of Nausea-vomiting ,total rescue antiemetic doses and any other complications including pain, agitation and sedation also will be recorded. All date will be statistically analyzed using SPSS v.16.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012511700N3
Registration date:2014-02-05, 1392/11/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-05, 1392/11/16
Registrant information
Name
Farnaz Moslemi Tabrizi
Name of organization / entity
Alzahra hospital, Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
moslemif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dexamethasone-ondansetrone for the prevention of nausea and vomiting after laparoscopy
Public title
Effect of combined dexamethasone-ondansetrone versus dexamethasone and ondansetrone alone for the prevention of nausea and vomiting after outpatient gynecological diagnostic laparoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: women with 20-50 years old; women with ASA physical status I and II; patients who have given informed concent
Exclusio criteria: patients with ASA physical status III or higher;cardiovascular disease; respiratory disease; gastrointestinal disease; hypertension; diabet; patients who had antiemetic therapy
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
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
Vice Chancellor for Reaserch, Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Ave, Tabriz
City
Tabriz
Postal code
Approval date
2013-02-18, 1391/11/30
Ethics committee reference number
92125
Health conditions studied
1
Description of health condition studied
Nausea and Vomiting
ICD-10 code
074.6
ICD-10 code description
Other complications of spinal and epidural anaesthesia during labour and delivery
Primary outcomes
1
Description
Nausea and Vomiting
Timepoint
In recovery room and until discharge of Hospital
Method of measurement
The intencity of nausea and vomiting with Belville score
Secondary outcomes
empty
Intervention groups
1
Description
Group 1, will recieve 8 mg IV Dexamethazone before induction of anesthesia
Category
Treatment - Drugs
2
Description
Group2 will recieve 4 mg IV ondansetron before induction of anesthesia
Category
Treatment - Drugs
3
Description
Group 3 will recieve 8 mg Dexamethazone and 4 mg Ondansetron IV before induction of anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr. Farnaz Moslemi
Street address
Alzahra Hospital, South Artesh Ave, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Farnaz Moslemi
Street address
Alzahra Hospital, South Artesh Ave, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farnaz Moslemi
Position
Associate Professor of Anesthesiology, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Alzahra Hospital, Artesh Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
+98 984115566449
Email
moslemi_fa@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of Medical Sciences
Full name of responsible person
Dr. Farnaz Moslemi
Position
Associate Professor of Anesthesiology, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Alzahra Hospital, Artesh Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
moslemi_fa@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
TTabriz University of MMedical Sciences
Full name of responsible person
Dr.Farnaz Moslemi
Position
Associate Professor of Anesthesiology, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Alzahra Hospital, Artesh Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
Moslemi_fa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)