Comparative study of dexamethasone versus placebo in the prevention of nausea and vomiting and postoperative pain in patients undergoing abdominal hysterectomy
Studying the effects of dexamethasone versus placebo in the prevention of nausea and vomiting and postoperative pain in patients undergoing abdominal hysterectomy.
Design
Clinical trial, placebo-controlled, with parallel groups, double-blinded, randomized with simple randomization
Settings and conduct
Patients are randomly assigned into two groups of 51 (single dose) dexamethasone 8 mg intravenous or normal saline (2 ml) as a placebo before surgery. In order to blindness dexamethasone (Tehran Chemistry Company) and saline were placed in a similar 2 ml syringe and placed at the disposal of the nurse for injection. After surgery, patients are transferred to recovery and are monitored for about 30 minutes. Pethidine is used to relieve pain in recovery patients.
Participants/Inclusion and exclusion criteria
This study is a double blind clinical trial. 102 patients over 30 years old with a BMI of 20-35 who are undergoing abdominal hysterectomy are included in the study. Exit criteria include patients with systemic diseases including diabetes, asthma, cancer, patients with a history of allergy or dexamethasone susceptibility, patients who had nausea and vomiting within 24 hours before surgery, patients who have gastrointestinal disturbances such as gastritis and esophagitis within 48 hours prior to anesthetic surgery.
Intervention groups
- Single dose of 8 mg intravenous dexamethasone infusion
- Normal saline (2 ml)
Main outcome variables
- Prevalence of nausea and vomiting
- Severity of nausea
- Need for anti-nausea drugs in postoperative times
- Severity of the pain felt by the patients is scored from 0 to 10.
- ِDuration of the surgery
- Duration of the hospital stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161220031487N8
Registration date:2018-04-08, 1397/01/19
Registration timing:registered_while_recruiting
Last update:2018-04-08, 1397/01/19
Update count:0
Registration date
2018-04-08, 1397/01/19
Registrant information
Name
مهرداد Mesbah kiaei
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 346 5866
Email address
dr.mmesbah@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of dexamethasone versus placebo in the prevention of nausea and vomiting and postoperative pain in patients undergoing abdominal hysterectomy
Public title
Studying the effects of dexamethasone in the prevention of nausea and vomiting and postoperative pain in patients undergoing abdominal hysterectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 30 years
Candidate for abdominal hysterectomy
Body mass index (BMI) from 20-35
Exclusion criteria:
Systemic disease such as diabetes, asthma or cancer
History of allergy to dexamethasone
Nausea and vomiting in 24 hours prior to operation
Receiving anti-emetics 48 hours before operation
Digestive system anomalies such as gastritis and esophagitis
Age
From 30 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using the Excel software random numbers function.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding, Dexamethasone (Tehran Chemistry Company) and saline were placed in a similar 2 ml syringe before operation and provided to the nurse for injection.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the Iran University of Medical Sciences
Street address
Next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1416771818
Approval date
2017-03-17, 1395/12/27
Ethics committee reference number
IR.IUMS.REC1395.9311290003
Health conditions studied
1
Description of health condition studied
Hysterectomy
ICD-10 code
Z90.7
ICD-10 code description
Acquired absence of genital organ(s)
Primary outcomes
1
Description
Prevalence of nausea and vomiting
Timepoint
Measurement at 0، 2، 4، 6، 12 and 24 hours after operation
Method of measurement
The severity of nausea is from 0 to 10, a score of 0 indicates a lack of nausea, and 10 means a very severe nausea.
2
Description
Severity of pain felt by patients
Timepoint
Measured at 0, 2, 4, 6, 12 and 24 hours after operation
Method of measurement
The severity of the pain felt by the patients is scored from 0 to 10, with zero indicating the absence of pain and 10 means a very severe pain.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Single dose of 8 mg intravenous dexamethasone infusion
Category
Treatment - Drugs
2
Description
Control group: normal saline (2 ml)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Shahla َAmirzargar
Street address
Behafarin st., Karimkhan st
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1201
Fax
Email
shahlaamirzargar@yahoo.com
Web page address
http://firoozgar.iums.ac.ir/
2
Recruitment center
Name of recruitment center
Shahid Akbar-Abadi Obstetrics and Gynecology Hospital
Full name of responsible person
Shahla Amirzargar
Street address
Mowlavi st.
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
shahlaamirzargar@yahoo.com
Web page address
http://crta.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Kazem Malakouti
Street address
Office of Vice-chancellor for Research, Iran University of Medical Sciences