Compare the effect of supplemental fluid therapy before and during breast cancer surgery on severity of post-operative nausea and vomiting and severity of pain.
Post operative nausea and vomiting (PONV) and pain are the most common complications after breast cancer surgery. The aim of this study is the compare of supplemental fluid therapy before and during breast cancer surgery on severity of post-operative nausea and vomiting and severity of post-operative pain. In this study, 60 patients who need to breast cancer surgery with age of 18-50 years old, without renal and cardiac disorder and weight below 100 kg, randomly assign in three groups. In the first group, all of patients receive usual fluid therapy in preoperative and during surgery. In the second group, all of the patients receive 5 cc/kg ringer-lactate serum at least 2 hours before surgery beside the usual fluid therapy. In the third group, all of the patients receive 5 cc/kg ringer-lactate serum during surgery beside the usual fluid therapy. Then, the severity of PONV and postoperative pain will be evaluated by a person who is not aware from groups of study. Severity of PONV and post-operative pain compare in three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201602116481N8
Registration date:2016-03-01, 1394/12/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-01, 1394/12/11
Registrant information
Name
Mohsen Soleimani
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
soli257@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2016-04-08, 1395/01/20
Expected recruitment end date
2018-03-11, 1396/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of supplemental fluid therapy before and during breast cancer surgery on severity of post-operative nausea and vomiting and severity of pain.
Public title
Compare the supplemental fluid therapy before and during breast cancer surgery on post-operative nausea and vomiting and pain after cancer breast surgery.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18-50 years; ASA (American Society of Anesthesiologists) physical status classification I and II.
Exclusion criteria: History of smoking; renal or cardiac disorder; unusual bleeding during surgery; weight above 100 kg; uncontrolled hypertension.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, 5th kilometer of Damghan road, Semnan, Iran.
City
Semnan
Postal code
Approval date
2016-02-09, 1394/11/20
Ethics committee reference number
IR.SEMUMS.REC.1394.169
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Post-operative nausea and vomiting
Timepoint
1, 4, 8, 24 hours after breast cancer surgery
Method of measurement
Post-operative nausea and vomiting questionnaire (Cortila)
Secondary outcomes
1
Description
Severity of pain
Timepoint
1, 4, 8, and 24 hours after surgery
Method of measurement
Visual analog scale
Intervention groups
1
Description
Intervention group 1: In this group, all of the patients beside the routine fluid therapy before and during breast cancer surgery, receive 5 cc/kg ringer-lactate serum from fasting time until 2 hours before surgery.
Category
Prevention
2
Description
Control group: In this group all of patients receive routine fluid therapy before and during breast cancer surgery.
Category
Other
3
Description
Intervention group 2: In this group, all of the patients beside the routine fluid therapy before and during breast cancer surgery, receive 5 cc/kg ringer-lactate serum during surgery.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohaday-Tajrish hospital
Full name of responsible person
Mohsen Soleimani
Street address
Semnan University of Medical Sciences
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Rashidy-pour
Street address
Semnan University of Medical Sciences
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
PhD in nursing
Other areas of specialty/work
Street address
Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 3344 1021
Fax
Email
Soli257@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
PhD in nursing
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Semnan, Iran.
City
Semnan
Postal code
Phone
+98 23 3344 1021
Fax
Email
Soli257@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
PhD in nursing
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Semnan, Iran.
City
Semnan
Postal code
Phone
+98 23 3344 1021
Fax
Email
Soli257@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)