Effect of Clonidine on Post-operative Nausea and Vomiting in Breast Cancer Surgery
Design
Double blinded randomized clinical trial
Settings and conduct
Intervention group:Patients are given 0.2 mg of clonidine tablets in the morning.
Control group: Patients are given one tablet in the morning as a placebo. (Made by Shiraz University of Medical Sciences School of Pharmacy), which is similar to clonidine tablets.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients Candidate for Breast Cancer Surgery ,Ages 15 to 70 years, ASA Class I-II General Anesthesia.
Exclusion criteria:A history of postoperative nausea and vomiting ,Patients who have received antiemetic drugs such as ondansetron or dexamethasone 24 hours before surgery ,History of motion sickness, Allergy to Propofol and Clonidine ,Concomitant use of beta-blocker medication that may affect a patient's heart rate, Systolic blood pressure less than 100, History of using Steroid, History of myocardial infarction ,History of tricyclic antidepressant use, History of kidney dysfunction.
Intervention groups
Intervention group:Patients are given 0.2 mg of clonidine tablets in the morning.
Control group: Patients are given one tablet in the morning as a placebo. (Made by Shiraz University of Medical Sciences School of Pharmacy), which is similar to clonidine tablets.
Main outcome variables
Post-operative Nausea and Vomiting, Hemodynamic changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141009019470N99
Registration date:2020-06-18, 1399/03/29
Registration timing:prospective
Last update:2020-06-18, 1399/03/29
Update count:0
Registration date
2020-06-18, 1399/03/29
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-21, 1399/04/31
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Title: Effect of Clonidine on Post-operative Nausea and Vomiting in Breast Cancer Surgery
Public title
Title: Effect of Clonidine on Post-operative Nausea and Vomiting in Breast Cancer Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients Candidate for Breast Cancer Surgery
Ages 15 to 70 years
ASA Class I-II
General Anesthesia
Exclusion criteria:
A history of postoperative nausea and vomiting
Patients who have received antiemetic drugs such as ondansetron or dexamethasone 24 hours before surgery
History of motion sickness
Allergy to Propofol and Clonidine
Concomitant use of beta-blocker medication that may affect a patient's heart rate
Systolic blood pressure less than 100
History of using Steroid
History of myocardial infarction
History of tricyclic antidepressant use
History of kidney dysfunction
Age
From 15 years old to 70 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups of four permutation blocks based on a randomization table from Randomization.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
A nurse in the ward gives patients clonidine or placebo tablets one hour before the patient enters the operating room on a randomized basis.
The patient, an individual assessment of the patient in the operating room , recovery room and ward nurses and are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2020-03-01, 1398/12/11
Ethics committee reference number
IR.SUMS.MED.REC.1398.653
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
D05.10
ICD-10 code description
Intraductal carcinoma in situ of unspecified breast
Primary outcomes
1
Description
Post-operative Nausea and Vomiting
Timepoint
Postoperative nausea and vomiting in recovery is recorded at 0-15-30 and 45 minutes. After transferring the patient to the surgical ward, the incidence of postoperative nausea and vomiting is evaluated at 6 and 24 hours.
Method of measurement
Likert
Secondary outcomes
1
Description
Hemodynamic changes
Timepoint
Blood pressure and heart rate are recorded in the surgical ward in the operating room before induction after induction and in recovery at 0-15-30 and 45 minutes.After transferring the patient to the surgical ward, the patient's blood pressure is checked at 24,2,4,6,12 hours.
Method of measurement
Monitoring
Intervention groups
1
Description
Intervention group:Patients are given 0.2 mg of clonidine tablets in the morning.
Category
Prevention
2
Description
Control group:Control group: Patients are given one tablet in the morning as a placebo. (Made by Shiraz University of Medical Sciences School of Pharmacy), which is similar to clonidine tablets.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faghihi Hospital
Full name of responsible person
Shabnam Heiydarinezhad
Street address
Zand Street, Faghihi Hospital
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 17 3235 1087
Email
faghihihsp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Email
sacrc@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Shabnam Heidarynezhad
Position
Anesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3674 4270
Email
shab.hn1998@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Akbari
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
akbaria@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
BS in anesthesia/English Consultant
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
5th floor, Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@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