Protocol summary
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Study aim
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The effect of Dexmedetomidine on Quality of Recovery after simple mastectomy under General anesthesia
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Design
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Double Blinded Randomized Clinical Trial with Parallel Group
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Postoperative pain
General information
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Reason for update
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Since I did not start the clinical trial until the IRCT registration, I changed the expected start date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20141009019470N100
Registration date:
2020-07-18, 1399/04/28
Registration timing:
prospective
Last update:
2020-07-28, 1399/05/07
Update count:
1
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Registration date
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2020-07-18, 1399/04/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-08-10, 1399/05/20
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Expected recruitment end date
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2020-10-21, 1399/07/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of Dexmedetomidine on Quality of Recovery after simple mastectomy under General anesthesia
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Public title
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The effect of Dexmedetomidine on Quality of Recovery after simple mastectomy under General anesthesia
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 25 years old to 65 years old
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Gender
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Female
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
110
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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 .
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-02-18, 1398/11/29
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Ethics committee reference number
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IR.SUMS.MED.REC.1398.633
Health conditions studied
1
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Description of health condition studied
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Mastectomy
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ICD-10 code
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Z42.1
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ICD-10 code description
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Encounter for breast reconstruction following mastectomy
Primary outcomes
1
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Description
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The agitation
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Timepoint
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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
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Method of measurement
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Ramsay criteria
2
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Description
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Nausea and vomiting
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Timepoint
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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
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Method of measurement
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Likert
3
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Description
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Postoperative pain
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Timepoint
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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
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Method of measurement
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Visual analogue scale
Intervention groups
1
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Description
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Intervention group:30 minutes before surgery, dexmedetomidine infusion will start at a dose of 0.4 mcg / kg.
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Category
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Prevention
2
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Description
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Control group:The 0.9% normal saline infusion will start at 0.1 cc / kg 30 min before surgery.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Its against our policies.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available