The goal of this study is comparison adequate intraoperative fluid therapy with dexamethasone on the incidence and severity of nausea and vomiting after general surgery. In this clinical trial, 120 patients undergoing general were randomly divided into 3 groups. Group one: adequate intraoperative fluid therapy, Group two: pharmacological intervention with dexamethasone 0.1 mg per kg of body weight -and group three: without prophylactic intervention. Patients should be alert and have class 1 and class 2 of America Society of Anesthesiology (ASA). The incidence and severity of nausea and vomiting during the surgery, 2 and 6 hours after the surgery was assessed by self report scale
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122019359N8
Registration date:2016-12-27, 1395/10/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-27, 1395/10/07
Registrant information
Name
Hossein Zeraati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3151 0000
Email address
zeraatih911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, North Khorasan University of Medical Sciences
Expected recruitment start date
2016-12-05, 1395/09/15
Expected recruitment end date
2017-02-03, 1395/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare adequate intraoperative fluid therapy with dexamethasone on the incidence and severity of nausea and vomiting
Public title
Compare adequate intraoperative fluid therapy with dexamethasone on the incidence and severity of nausea and vomiting after general
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients should be alert; having class 1 and class 2 of America Society of Anesthesiology (ASA) score
Exclusion criteria: the patients who weigh more than 90 kg; diabetics; with underlying gastrointestinal disease; those who had used anti-nausea and anti-vomiting drugs in pre-operative 24 hours before the surgery; those who were not fasting; those with middle ear disease; those who had more than 20% of baseline drop in blood pressure after spinal anesthesia; history of nausea and vomiting during the past 24 hours
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of North Khorasan University of Medical Sciences
Street address
Vice Chancellor for Research of North Khorasan University of Medical Sciences, Bojnurd
City
Bojnurd
Postal code
Approval date
2013-03-05, 1391/12/15
Ethics committee reference number
92P617
Health conditions studied
1
Description of health condition studied
Anesthesia
ICD-10 code
R10-119
ICD-10 code description
Symptoms and signs involving the digestive system and abdomen
Primary outcomes
1
Description
severity of nausea
Timepoint
During the surgery, 2 hour after the surgery, 6 hour after the surgery
Method of measurement
self-report scale
2
Description
Severity of vomiting
Timepoint
During the surgery, 2 hour after the surgery, 6 hour after the surgery
Method of measurement
self-report scale
Secondary outcomes
empty
Intervention groups
1
Description
The first Group: Under the prophylactic treatment liquid
Category
Other
2
Description
The second Group: pharmacological intervention with dexamethasone 0.1 mg per kg of patient weight
Category
Treatment - Drugs
3
Description
The third group: without prophylactic interventions to prevent nausea and vomiting
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Ali Hospital
Full name of responsible person
Javad Shahinfar
Street address
Emam Ali Hospital, Bojnurd, Iran.
City
Bojnurd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, North Khorasan University of Medical Sciences
Full name of responsible person
Alireza Golshan
Street address
Vice Chancellor for Research, North Khorasan University of Medical Sciences, Bojnurd, Iran
City
Bojnurd
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, North Khorasan 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
North Khorasan University of Medical Sciences
Full name of responsible person
Javad Shahinfar
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahriyar Ave, Bojnurd, Iran
City
Bojnurd
Postal code
Phone
+98 58 3229 6966
Fax
Email
dr.jshahinfar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Javad Shahinfar
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahriyar Ave, Bojnurd, Iran
City
Bojnurd
Postal code
Phone
+98 58 3229 6966
Fax
Email
dr.jshahinfar@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Javad Shahinfar
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahriyar Ave, Bojnurd, Iran
City
Bojnurd
Postal code
Phone
+98 58 3229 6966
Fax
Email
dr.jshahinfar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)