The effect of intraperitoneal and intravenous dexamethasone in reduce pain and nausea and vomiting after gynecology laparoscopic surgery
Design
A randomized clinical trial with the parallel group. Phase 2-3 was performed on 60 patients with laparoscopic gynecological surgery, two-way, blind, randomized groups, and for randomization by the randomized block method.
Settings and conduct
This clinical trial study is performed in Shahid Akbarabadi Hospital in Tehran. Patients who need laparoscopic surgery due to a gynecological indication are included in the study. In the first intervention, group8 mg dexamethasone (2 CC) was intravenously injected. and 2 CC normal saline peritoneal cavity after surgery and before leaving the trocar was sprayed. In the second group 8 mg dexamethasone (2 CC) peritoneal cavity was sprayed, and 2 CC normal saline intravenously injected after surgery and before leaving the trocar was.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ages between 18 and 60 years, Patients who need laparoscopic surgery due to a gynecological indication
exclusion criteria: History of abdominal surgery, Extensive pelvic surgeries
Body mass index(BMI) of more than 40(kg/m^2), Existence of diseases of the stomach and intestines, allergy to dexamethasone.
Intervention groups
8 mg dexamethasone (2 CC) intravenously injected. and 2 CC normal saline peritoneal cavity after surgery and before leaving the trocar was sprayed.
8 mg dexamethasone (2 CC) peritoneal cavity sprayed, and 2 CC normal saline intravenously injected after surgery and before leaving the trocar was
Main outcome variables
The severity of nausea, vomiting, and postoperative pain by Visual Analogue Scale (VAS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160523028008N18
Registration date:2021-09-30, 1400/07/08
Registration timing:prospective
Last update:2021-09-30, 1400/07/08
Update count:0
Registration date
2021-09-30, 1400/07/08
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-01, 1400/08/10
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intra peritoneal and intravenous dexamethasone in reduce pain and nausea and vomiting after gynecology laparoscopic surgery.
Public title
Effect of intraperitoneal and intravenous dexamethasone in reduce pain and nausea and vomiting after laparoscopic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages between 18 and 60 years
Patients who need laparoscopic surgery due to a gynecological indication
Exclusion criteria:
History of abdominal surgery
Extensive pelvic surgeries
Body mass index(BMI) of more than 40
Existence of diseases of the stomach and intestines
Drug allergy to dexamethasone
Age
From 18 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, dexamethasone and normal saline were pre-prepared by the operating room nurse in one volume and labeled A and B. It is then given daily to the researcher and will be used randomly for patients
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat High Way
City
Tehran
Province
Tehran
Postal code
1168743514
Approval date
2020-11-14, 1399/08/24
Ethics committee reference number
IR.IUMS.FMD.REC.1399.575
Health conditions studied
1
Description of health condition studied
Laparoscopic surgical
ICD-10 code
Z53.31
ICD-10 code description
Laparoscopic surgical procedure converted to open procedure
Primary outcomes
1
Description
Severity of nausea
Timepoint
6, 12, 18 and 24 hours after surgery
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Severity of vomiting
Timepoint
6, 12, 18 and 24 hours after surgery
Method of measurement
Visual Analogue Scale (VAS)
3
Description
Severity of pain
Timepoint
6, 12, 18 and 24 hours after surgery
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 8 mg dexamethasone (2 CC) intravenously injected. and 2 CC normal saline peritoneal cavity after surgery and before leaving the trocar was sprayed.
Category
Treatment - Drugs
2
Description
Intervention group: 8 mg dexamethasone (2 CC) peritoneal cavity sprayed, and 2 CC normal saline intravenously injected after surgery and before leaving the trocar was.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbar Abadi Hospital
Full name of responsible person
Azadeh Akbari sene
Street address
shahid Akbar Abadi Hospital, Ferdowsi Station, Molavi st, Tehran
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 6655 2972
Email
akbarisene@aiums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Doctor Syed Ali Javad Mousavi
Street address
shahid Akbar Abadi Hospital, Ferdowsi Station, Molavi st, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2506
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Azadeh Akbari sene
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
shahid Akbar Abadi Hospital,Ferdowsi Station, Molavi st, Tehran
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 6655 2972
Email
akbarisene@aiums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azadeh Akbari sene
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
shahid Akbar Abadi Hospital, Ferdowsi Station, Molavi st, Tehran
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 6655 2972
Email
akbarisene@aiums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Neda Ardeshiri
Position
Resident of Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
shahid Akbar Abadi Hospital,Ferdowsi Station, Molavi st, Tehran
City
Tehran
Province
Tehran
Postal code
116874354
Phone
+98 21 6655 2972
Email
nedaa_Ardeshiri1368@yahoo.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