The effect of Dexmedetomidine on Quality of Recovery after simple mastectomy under General anesthesia
Design
Double Blinded Randomized Clinical Trial with Parallel Group
Settings and conduct
Intervention group: Patients in the intervention group will begin 30 min before surgery with a dose of 0.4 mcg / kg for the dexmedetomidine infusion.
Control group: Patients in the control group will receive 0.9% normal saline infusion at a rate of 0.1 cc / kg for 30 min before surgery.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients undergoing simple mastectomy surgery Age 25-65 years ASA Class I – II.
Exclusion Criteria: History of heart failure, History of Kidney Failure, History of liver failure, Psychiatric and cognitive disorders, Chronic pain, Drug abuse or using psychotropic drugs, Pregnancy, Alcohol abuse, Long-term use of painkillers History of allergy to dexmedetomidine, Redo surgery, History of motor disease.
Intervention groups
Intervention group: Patients in the intervention group will begin 30 min before surgery with a dose of 0.4 mcg / kg for the dexmedetomidine infusion.
Control group: Patients in the control group will receive 0.9% normal saline infusion at a rate of 0.1 cc / kg for 30 min before surgery.
Main outcome variables
Postoperative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141009019470N100
Registration date:2020-07-18, 1399/04/28
Registration timing:retrospective
Last update:2020-07-18, 1399/04/28
Update count:1
Registration date
2020-07-18, 1399/04/28
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
2020-04-18, 1399/01/30
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Dexmedetomidine on Quality of Recovery after simple mastectomy under General anesthesia
Public title
The effect of Dexmedetomidine on Quality of Recovery after simple mastectomy under General anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing simple mastectomy surgery
Age 25-65 years
ASA Class I – II
Exclusion criteria:
History of heart failure
History of Kidney Failure
History of liver failure
Psychiatric and cognitive disorders
Chronic pain
Drug abuse or using psychotropic drugs
Pregnancy
Alcohol abuse
Long-term use of painkillers
History of allergy to dexmedetomidine
Redo surgery
History of motor disease
Age
From 25 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into two groups of 55, using the table from www.randomization.org.Patients are divided into groups A and B and treated according to their group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The dexmedetomidine infusion will begin thirty minutes before the end of surgery in the first group.
In the second group, 0.9% normal saline infusion will begin 30 minutes before the surgery.
While the anesthesiology nurse who provides dexmedetomidine and normal saline syringes and gives them to the anesthesiology resident in the operating room is unaware of the study groups.
Data collection is done in the recovery and ward by nursing staff who is unaware of the amount of medication received in the 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
2020-02-18, 1398/11/29
Ethics committee reference number
IR.SUMS.MED.REC.1398.633
Health conditions studied
1
Description of health condition studied
Mastectomy
ICD-10 code
Z42.1
ICD-10 code description
Encounter for breast reconstruction following mastectomy
Primary outcomes
1
Description
The agitation
Timepoint
It is examined every 30 minutes for 2 hours in recovery as well as after the patient is transferred to ward every 2 to 6 hours
Method of measurement
Ramsay criteria
2
Description
Nausea and vomiting
Timepoint
It is examined every 30 minutes for 2 hours in recovery as well as after the patient is transferred to ward every 2 to 6 hours
Method of measurement
Likert
3
Description
Postoperative pain
Timepoint
It is examined every 30 minutes for 2 hours in recovery as well as after the patient is transferred to ward every 2 to 6 hours
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:30 minutes before surgery, dexmedetomidine infusion will start at a dose of 0.4 mcg / kg.
Category
Prevention
2
Description
Control group:The 0.9% normal saline infusion will start at 0.1 cc / kg 30 min before surgery.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Faghihi Hospital
Full name of responsible person
Ayda Najafi Kashkooli
Street address
Zand Street, Faghihi Hospital
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 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
Phone
+98 71 3647 4270
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
Ayda Najafi Kashkooli
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 3647 4270
Email
ida_najafi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Saied Khademi
Position
Cardio-anesthesiologist
Latest degree
Subspecialist
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
khademish@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