The Comparison Effect Of ondansetron and Ginger on Incidence and Severity of Postoperative Nausea and Vomiting in Patients Undertaken Ophthalmic Surgery
The aim of the study is to determine the effect of ondansetron and ginger on occurrence and severity of nausea and vomiting after eye surgery on patients. Participants in this study are 150 patients undergoing eye surgery. All patients were chosen to be between 18 and 60 years old, able to swallow capsules used in the study and also not sensitive to ginger or ondansetron. Sampling was done continuously based on availability. Participants were divided into three blocks. The first three persons were randomly chosen using three cards (A, B, C). Patients were randomized into three groups (receiving ginger, ondansetron and placebo). The severity of nausea and vomiting in patients were determined by a researcher who was unaware of the patients’ treatment regime, using standard tools and a checklist. This was done once the patient was recovered, 2, 4 and 6 hours after the surgery.. Probable events(abdominal pain, heartburn, shortness of breath, diarrhea and insomnia) were recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014060918020N1
Registration date:2014-07-02, 1393/04/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-02, 1393/04/11
Registrant information
Name
Shahnam Sadigh Maroufi
Name of organization / entity
Faculty of Allied Medicine (IUMS)
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4732
Email address
sedighmaroufi.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Iran University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison Effect Of ondansetron and Ginger on Incidence and Severity of Postoperative Nausea and Vomiting in Patients Undertaken Ophthalmic Surgery
Public title
The Comparison Effect Of ondansetron and Ginger on Postoperative Nausea And Vomiting after Ophthalmic Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Lack of cancer; Age 18 to 60 years; Ability to swallow capsules used in the study; Platelet count above 100 thousand; Not suffering from intestinal obstruction and hepatitis; Not pregnant; Absence epilepsy, diabetes and kidney disease; Lack of anti-emetic drugs; Lack of long-term treatment with corticosteroids; No history of allergy to ginger or ondansetron
Exclusion Criteria: Severe nausea and vomiting after surgery and require to use antisemitic
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University Campus, Hemmat freeway, next to Milad tower Tehran, Iran
City
Tehran
Postal code
Approval date
2014-06-17, 1393/03/27
Ethics committee reference number
101568
Health conditions studied
1
Description of health condition studied
Glaucoma
ICD-10 code
H40
ICD-10 code description
Glaucoma
2
Description of health condition studied
Paralytic strabismus
ICD-10 code
H49
ICD-10 code description
Paralytic strabismus
3
Description of health condition studied
cataract
ICD-10 code
H25
ICD-10 code description
capsular glaucoma with pseudoexfoliation of lens
Primary outcomes
1
Description
Nausea
Timepoint
2,4,6 hours after surgery
Method of measurement
Using a Check lists and standard tools
2
Description
Vomiting
Timepoint
2,4,6 hours after surgery
Method of measurement
Using a Check lists and standard tools
Secondary outcomes
1
Description
Cramp
Timepoint
2, 4, 6 hours after surgery
Method of measurement
Visual analysis and Scoring
2
Description
Heartburn
Timepoint
2, 4, 6 hours after surgery
Method of measurement
Visual analysis and Scoring
3
Description
Dyspenia
Timepoint
2, 4, 6 hours after surgery
Method of measurement
Visual analysis and Scoring
4
Description
diarrhea
Timepoint
2, 4, 6 hours after surgery
Method of measurement
Visual analysis and Scoring
5
Description
Insomnia
Timepoint
2, 4, 6 hours after surgery
Method of measurement
Visual analysis and Scoring
Intervention groups
1
Description
Intervention 1: administration of ginger capsules contain 1000 mg drug with 30 cc water 1 hour before surgery
Category
Treatment - Drugs
2
Description
Control: administration of placebo capsule with 30 cc water 1 hour before surgery
Category
Treatment - Drugs
3
Description
Intervention 2: administration of Ondansetron capsules contain 16 mg drug with 30 cc water 1 hour before surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Fereshte Kabiri
Street address
Satarkhan St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Seyyed Ali Javad Mousavi
Street address
Iran University Campus, Hemmat FreeWay, Next to Milad Tower Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Iran 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
Iran University of Medical Sciences
Full name of responsible person
Parisa Moradi Majd
Position
Master of Sciences
Other areas of specialty/work
Street address
Iran University Campus, Hemmat FreeWay, Next to Milad Tower Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8670 4727
Fax
Email
moradimajd.p@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shahnam Sadigh Maruofi
Position
PhD Student Of Medical Education
Other areas of specialty/work
Street address
Iran University Campus, Hemmat FreeWay, Next to Milad Tower Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8670 4732
Fax
Email
shsphd@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Moradi Majd
Position
Master Of Science
Other areas of specialty/work
Street address
Iran University Campus, Hemmat FreeWay, Next to Milad Tower Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8670 4727
Fax
Email
moradimajd.p@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)