Comparison of Pre-emptive with Preventive Effect of Intravenous Ondansetron on severity of Postoperative Nausea and Vomiting after Diagnostic Gynecologic Laparoscopy
Postoperative nausea and vomiting (PONV) remains the most common postoperative complication. The aim of the present study is to compare the antiemetic effect of intravenous ondansetron before the beginning of surgery or at the end of operation for prophylaxis of PONV in patients undergoing diagnostic gynecologic laparoscopy under general anesthesia. Exclusion criteria is history of systemic disease, motion sickness recently taking opioid and corticosteroid. In this randomized blinded clinical trial, 80 patients with ASA class I and aged 20-40 years are randomly allocated into two equal groups. Ondansetron 4mg is administered prior to induction of anesthesia in the study group (n=40), or at the end of surgery in the control group(n=40). Severity of nausea (as measured on a10-cm visual analogue scale), number of emetic episodes, first request to antiemetic, and total dose of antiemetic are recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402037013N9
Registration date:2014-02-18, 1392/11/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-18, 1392/11/29
Registrant information
Name
Simin Atashkhoei
Name of organization / entity
Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 3806
Email address
atashkhoii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tabriz University of Medicalُ Sciences
Expected recruitment start date
2013-12-30, 1392/10/09
Expected recruitment end date
2014-12-29, 1393/10/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Pre-emptive with Preventive Effect of Intravenous Ondansetron on severity of Postoperative Nausea and Vomiting after Diagnostic Gynecologic Laparoscopy
Public title
Comparison the effect of intravenous ondansetron before or the end of surgery on severity of postoperative nausea and vomiting after diagnostic gynecologic laparoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Women aged 20-40 years; ASA class 1; scheduled for diagnostic gynecologic laparoscopy
Exclusion criteria: vaginal hemorrhage; taking any medication, including corticosteroids , opioids and antiemetics; history of systemic disease( cardiovascular, respiratory, renal ,…); history of motion sickness; history of gastrointestinal disease; pregnancy
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research, Tabriz University of Medicalُ Sciences
Street address
Research Vice Chancellor; Daneshgah Street; Tabriz
City
TABRIZ
Postal code
Approval date
2013-12-30, 1392/10/09
Ethics committee reference number
92163
Health conditions studied
1
Description of health condition studied
Complications of medical and surgical care
ICD-10 code
Y83-Y84
ICD-10 code description
Surgical and other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
Intensity of nausea and vomiting
Timepoint
Recavery and at 3, 6,and 24h postoperatively
Method of measurement
Visual analogue scoring 0-10cm(0=non to 10= vomiting more than 2 times)
Secondary outcomes
1
Description
Total dose of antiemeticafter operation
Timepoint
Recovery and during 24h postoperatively
Method of measurement
mg
Intervention groups
1
Description
Iin the control group (n=40), Ondansetron 4mg is administered prior to induction of anesthesia.
Category
Prevention
2
Description
In the study group (n=40) Ondansetron 4mg is administered at the end of surgery.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Dr.Simin Atashkhoyi
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice Chancellor of Tabriz University, Medical Sciences
Full name of responsible person
Dr. Rashidi
Street address
Research Vice Chanceller, Tabriz University, Daneshgah Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice Chancellor of Tabriz University, 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. Simin Atashkhoyi
Position
Anesthesiologist/ Professor
Other areas of specialty/work
Street address
Al-Zahra Hospital; South Artesh street; Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
satashkhoyi@gmail.comsiminatashkhoii@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. Simin Atashkhoyi
Position
Anesthesiologist/ Professor
Other areas of specialty/work
Street address
Al-Zahra Hospital; South Artesh street; Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
satashkhoyi@gmail.comsiminatashkhoii@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Anesthesiologist/ Professor
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)