effects of Intra-peritoneal Dexamethasone on preventing nausea/vomiting after laparoscopic gynecologic surgeries.
Design
double-blind randomised control trial with parallel groups,80 people will be assigned to two equal groups with block design randomisation
Settings and conduct
This study will be performed on 80 ASA-grade female patients in grades 1 and 2 who are candidates for elective gynecologic laparoscopic surgery in Shahid Sadoughi Hospital (in Yazd, Iran) between the ages of 18 and 70 years. In the first group, 20 cc normal saline is sprayed in the diaphragm and peritoneal cavity after surgery and before the removal of trocar. In the second group, 20 cc normal saline containing 16 mg dexamethasone will be sprayed in the diaphragm and peritoneal cavity after surgery and before removal of trocar. The patient will be ex-tubated and transported to recovery after appropriate alertness and breathing. The patient and the person follow the patient and filling out the questionnaire will not be informed of any of the medications used (dexamethasone or placebo).After surgery, the frequency of nausea and vomiting is measured at 1, 2, 4, 12, 18, 24 hours.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women aged 18 to 70 years old with ASA class 1 or 2 who are candidates for elective gynecologic laparoscopic surgery.
Exclusion criteria: body mass index >30, diabetes or other underlying diseases, histories of abdominal surgery or chronic pain, consuming anti-emetic drugs within 48 hours before surgery, history of long-term analgesics therapy, addiction, as well as allergy to anesthetic drugs and dexamethasone were considered as exclusion criteria.
Intervention groups
Intervention group receives 16 mg intra-peritoneal dexamethasone in 20 ml normal saline and placebo group receives 20 cc normal saline intra-peritoneally
Main outcome variables
Nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180702040309N1
Registration date:2020-05-14, 1399/02/25
Registration timing:prospective
Last update:2020-05-14, 1399/02/25
Update count:0
Registration date
2020-05-14, 1399/02/25
Registrant information
Name
Zahra Ghodratipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3823 6326
Email address
zahra.ghodratipour@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-07-10, 1399/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intraperitoneal dexamethasone: a new method for preventing nausea and vomiting after gynecological laparoscopic surgery
Public title
Effect of intra-peritoneal Dexamethasone on Nausea and Vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18 to 70 years old
Female gender
Class 1 or 2 of American Society of Anesthesiologists Classification
Candidates for elective gynecologic laparoscopic surgery
Exclusion criteria:
Body mass index (BMI) >30,
diabetes or other underlying diseases
histories of abdominal surgery or chronic pain
consuming antiemetic drugs within 48 hours before surgery
history of long-term analgesics therapy
Addiction to any kinds of substances
allergy to anesthetic drugs and dexamethasone
Age
From 18 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Given the sample size of 80 people, Sampling will be done in 20 blocks of four. In each block, two individuals will be randomly assigned to the intervention group and two others to the control group, so that all six states of a four-block may be selected ten times randomly from the blocks. By the end, forty people in each group will be randomly assigned.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug and placebo will be prepare and coded in uniform syringes.
A person who is not informed about the contain of each syringe administer the drugs.Researchers who are unaware about the drugs and patients of each group will record the data.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Yazd University of Medical Sciences
Street address
Vice Chancellor for Research, Central Administration, Bahonar Sq., Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2017-03-04, 1395/12/14
Ethics committee reference number
5301
Health conditions studied
1
Description of health condition studied
gynecological laparoscopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
nausea score
Timepoint
1, 2, 4, 12, 18, 24 hours after surgery
Method of measurement
No - mild - moderate - severe
2
Description
vomiting score
Timepoint
1, 2, 4, 12, 18, 24 hours after surgery
Method of measurement
None - 1 time - 2 or 3 times - more than 3 times
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 20 ml normal salin containing dexamethasone (16 mg) were injected into diaphragm and peritoneal cavity after the surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi hospital
Full name of responsible person
Zahra Ghodratipour
Street address
Shahid Ghandi Blvd, Safaieh, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
sadoghi-hospital@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
masoud mirzaei
Street address
Central Administration, Bahonar Sq., Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3146 2136
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Zahra Ghodratipour
Position
medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 17, Sepahsalar Ave., Esfahan
City
esfahan
Province
Isfehan
Postal code
8866874414
Phone
+98 31 3630 8409
Email
zahra.ghodratipour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zahra Ghodratipour
Position
medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 17, Sepahsalar Ave., Esfahan
City
esfahan
Province
Isfehan
Postal code
8866874414
Phone
+98 31 3630 8409
Email
zahra.ghodratipour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
zahra ghodratipour
Position
medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Central Administration, Bahonar Sq., Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
info@ssu.ac.ir
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
There is no necessity for publishing the raw data.