Comparison of effect of ondansetrone plus dexamethasone and metoclopramide plus dexamethasone on postoperative nausea and vomiting in Gynecological Laparoscopic Surgery
1. Determination of nausea and vomiting after laparoscopic surgery in women in ondansetron-dexamethasone group
2. Determination of nausea and vomiting after laparoscopic gynecologic surgery in metoxlopramide-dexamethasone group
Design
Randomised, superiority, parallel group trial with blinded outcome assessment. Balanced block randomization(random blocks). In each block, 2 patients are randomly assigned random codes A and B.
Settings and conduct
The study was performed at the Women's Surgery Center at Besat Hospital in Sanandaj. In this study, to compare the effects of postoperative nausea and vomiting 15 minutes before surgery, the first group received ondansetron 4mg plus dexamethasone 8mg and the second group received 10mg metoclopramide plus dexamethasone 8mg intravenously to patients undergoing laparoscopic surgery under General anesthesia will be prescribed.
Participants/Inclusion and exclusion criteria
Fasting for 8 hours before surgery, ASA 1&2 classification, Not having a history of co-existing diseases such as: cardiovascular, respiratory, neurological, diabetes, gastrointestinal diseases and motion sickness
Intervention groups
The first group will receive 4mg ondansetron plus 8mg dexamethasone intravenously.
The second group will receive 10 mg of metoclopramide plus 8 mg of dexamethasone intravenously.
Main outcome variables
1. The rate of nausea and vomiting after laparoscopic surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171216037910N2
Registration date:2019-08-31, 1398/06/09
Registration timing:retrospective
Last update:2019-08-31, 1398/06/09
Update count:0
Registration date
2019-08-31, 1398/06/09
Registrant information
Name
Arvin Barzanji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3334 2561
Email address
arvin.barzanji1988@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-10, 1396/03/20
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
2017-06-22, 1396/04/01
Actual recruitment end date
2018-05-02, 1397/02/12
Trial completion date
2018-05-04, 1397/02/14
Scientific title
Comparison of effect of ondansetrone plus dexamethasone and metoclopramide plus dexamethasone on postoperative nausea and vomiting in Gynecological Laparoscopic Surgery
Public title
The effect of ondansetrone and metoclopramide on postoperative nausea and vomiting in Gynecological Laparoscopic Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Fasting for 8 hours before surgery
ASA classification 1& 2
No history of co-existing disease: cardiovascular, respiratory, diabetes, gastrointestinal and motion sickness.
Exclusion criteria:
History of post operative nausea and vomiting
emergency surgery
Become an open surgical procedure
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
61
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced (permuted) block randomization(random blocks). In each block, 2 patients are randomly assigned random codes A and B, and according to the corresponding code, they receive the dose and the desired drug or placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study (metoclopramide and ondansetron) were prepared and coded by an anesthetist who was not involved in the study. At the specified time, the coded drugs plus dexamethasone were administered by an anesthesiologist who was not involved in the study. Patients were evaluated by trained nurses who were not aware of the grouping of patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Faculty of Medicine, Kurdistan University of Medical Sciences, Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2017-05-14, 1396/02/24
Ethics committee reference number
IR.MUK.REC.1396/29
Health conditions studied
1
Description of health condition studied
Post operative nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Post operative nausea and vomiting
Timepoint
ٍEmergence of anesthesia (time zero), on arrival to recovery, and at 2, 4, 6, 12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intravenous administration of 4mg ondansetron plus 8mg dexamethasone.
Category
Prevention
2
Description
Intervention group: Intravenous administration of 10mg metoclopramide with 8mg dexamethasone.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Khadijeh Daseh
Street address
Merdoux Crossroads- Keshavarz Street
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3328 5910
Email
besathospital@muk.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ebrahim Ghaderi
Street address
Faculty of Medicine, Kurdistan University of Medical Sciences, Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6614713446
Phone
+98 87 3366 4351
Email
f.rezaee@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Khadijeh Daseh
Position
Anesthesit
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Paramedical faculty, Medical University of Kurdistan, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6614713446
Phone
+98 87 3334 2561
Email
fereshtehdaseh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Khadijeh Daseh
Position
Anesthesit
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Paramedical faculty, Medical University of Kurdistan, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6614713446
Phone
+98 87 3334 2561
Email
fereshtehdaseh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Arvin Barzanji
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Paramedicine, Medical University of Kurdistan, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6616994745
Phone
+98 87 3334 2561
Fax
Email
arvin.barzanji1988@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information.
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