The Effect of Intraoperative Infusion of Dexmedetomidine on Acute and chronic postoperative pain after simple mastectomy
Design
Double Blinded Randomized Clinical Trial
Settings and conduct
During surgery patients in the operating room in the intervention group received dexmedetomidine infusion of 0.4 mg / kg to control postoperative pain . The infusion is given to the patient.And in the control group: 40 ml distilled water in the syringe is infused into the patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients undergoing simple mastectomy 18-65 years ASA I& II
Exclusion criteria:Sensitivity to dexmedetomidine, History of heart failure (EF <40%) ,Kidney Disorders (Creatinine greater than 2), History of liver disease,Psychiatric and cognitive disorders ,Chronic pain ,Drug and cigarette abuse, Psychotropic drugs and forgetfulness, Pregnancy Alcohol abuse, Arthritis, Chronic use of opioids, hypnotics and non-opioid analgesics, Diabetes for more than 10 years.
Intervention groups
Intervention group: Dexmedetomidine is injected to the patient at a dose of 0.4 mcg / kg.
Control group:40 ml distilled water is injected into the syringe as an infusion.
Main outcome variables
Chronic pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141009019470N90
Registration date:2019-11-27, 1398/09/06
Registration timing:prospective
Last update:2019-11-27, 1398/09/06
Update count:0
Registration date
2019-11-27, 1398/09/06
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
2019-12-06, 1398/09/15
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Intraoperative Infusion of Dexmedetomidine on Acute and chronic postoperative pain after simple mastectomy
Public title
The Effect of Intraoperative Infusion of Dexmedetomidine on Acute and chronic postoperative pain after simple mastectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing simple mastectomy
18-65 years
ASA I& II
Exclusion criteria:
Sensitivity to dexmedetomidine
History of heart failure (EF <40%)
Kidney Disorders (Creatinine greater than 2)
History of liver disease
Psychiatric and cognitive disorders
Chronic pain
Drug and cigarette abuse Psychotropic drugs and forgetfulness
Pregnancy
Alcohol abuse
Arthritis
Chronic use of opioids, hypnotics and non-opioid analgesics,
Having diabetes for more than 10 years
Cases in which the surgeon decides to change the surgical procedure for any reason
Age
From 18 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Patients randomized block permutation through 55 were divided into two groups www.Randomization.com site.
Blinding (investigator's opinion)
Double blinded
Blinding description
The volume of a 2 cc vial of dexmedetomidine is 200 mcg.
Therefore, 38 ml of distilled water is added to the dexmedetomidine vial.
As a result, each 1 cc is equivalent to 5 mcg and is eventually infused at a dose of 0.4 mcg / kg.
The placebo group received 40 ml of distilled water in the syringe as an infusion. The nurse responsible for completing the questionnaires and the nurse responsible for treating patients as well as patients in both groups were not aware of the assignment of patients to 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
2019-07-22, 1398/04/31
Ethics committee reference number
IR.SUMS.MED.REC.1398.297
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
Acute pain
Timepoint
The patient's pain is assessed 24 hours after surgery in the recovery room (on arrival at recovery and at the first and second hours) every 4 hours.
Method of measurement
Visual Analogue Scale
2
Description
Chronic pain
Timepoint
Three months after surgery
Method of measurement
Brief Pain Inventory
Secondary outcomes
1
Description
Total Morphine Consumption
Timepoint
Up to 24 hours after surgery
Method of measurement
Observasion
Intervention groups
1
Description
Intervention group: Dexmedetomidine is injected to the patient at a dose of 0.4 mcg / kg.
Category
Prevention
2
Description
Control group:40 ml distilled water is injected into the syringe as an infusion.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahi Faghihi Hospital
Full name of responsible person
Maryam Noorizadeh
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
dr.maryamnoorizadeh@gmail.com
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
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
vcrdep@sums.ac
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
Maryam Noorizadeh
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
dr.maryamnoorizadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Saeed Khademi
Position
Cardio-Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street