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Comparison of dexmedetomidine versus propofol intravenous sedation for electrochemotherapy of breast cancer skin lesion: double-blinded clinical trial

Protocol summary

Study aim
Comparison of the effect of dexmedetomidine and propofol injection in electrochemotherapy of breast cancer skin lesions
Design
A concealed, randomized, blinded trial with a double-arm, paralleled group design
Settings and conduct
36 cards will be placed in sealed opaque envelopes and shuffled. Patients will choose the selected envelopes without knowing their contents. Only those responsible for the randomization process will know which cards are in each envelope, while other members of the research team are kept unaware. Then, the anesthesiologist opens the sealed envelope. Based on the grouping in the opened envelope, the anesthesiologist prescribes the medicine to the patient. Medicines are injected with the same image and in such a way that the patient does not know the difference between them. In this study, propofol is injected with a dose of 25 -75 macro/min/kg. Dexmethomidine is prescribed first with a bolus dose of 0.5 to one macro/kg and then one-tenth to one macro/kg per hour. The study will be held at Loghman Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Symptomatic skin metastases (bleeding, exudation, smell or wound), lack of response to systemic treatment for skin lesions, patient's own preference for electrochemistry, multiple skin lesions or lesion larger than 1 cm, ASA group II, I, III, patients between 18 Up to 60 years, exclusion criteria: Pregnancy and breastfeeding. Allergy to any of the drugs used in the study, blood pressure, impaired liver and kidney function. Hereditary heart diseases, ischemic heart disease, smoking, using beta blockers and sedative drugs or refusing to sign an informed consent form.
Intervention groups
dexmedetomidine or propofol injection in breast cancer patients with skin metastasis who are candidates for electrochemotherapy
Main outcome variables
NPS ;RSS ;Aldrete score; Bispectral Index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240515061805N1
Registration date: 2024-05-23, 1403/03/03
Registration timing: registered_while_recruiting

Last update: 2024-05-23, 1403/03/03
Update count: 0
Registration date
2024-05-23, 1403/03/03
Registrant information
Name
Azin Tahvildari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1507
Email address
aziniza76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-22, 1403/03/02
Expected recruitment end date
2024-07-17, 1403/04/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of dexmedetomidine versus propofol intravenous sedation for electrochemotherapy of breast cancer skin lesion: double-blinded clinical trial
Public title
Comparison of the Effectiveness of dexmedetomidine and propofol in electrochemotherapy of breast cancer skin lesion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Symptomatic metastatic skin lesions (like bleeding, exudation, smell or ulceration) development of skin metastases, in which the symptoms mentioned can be expected Patients who receive systemic treatment and have a good effect on their primary cancer, but their skin lesions do not respond to these treatments or are progressing patients preferring electrochemistry multiple skin lesions or a lesion larger than 1 cm ASA group II, I, III patients between 18 and 60 years old
Exclusion criteria:
Pregnancy and breastfeeding Allergy to any of the drugs used in the study hypertension impaired liver and kidney function Hereditary heart diseases ischemic heart disease, smoking using beta blockers and sedative drugs refusing to sign an informed consent form
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Using simple method randomization, 36 cards (18 cards for each group) will be placed inside opaque sealed envelopes. The envelopes will then be shuffled and chosen by the patients. Except for the people who are responsible for randomization, other members of the research the team are blinded.
Blinding (investigator's opinion)
Double blinded
Blinding description
The envelopes will then be shuffled and chosen by the patients. Except for the people who are responsible for randomization, other members of the research team are blinded. Medicines are injected with the same image, in such a way that the patient does not know the difference between them. Furthermore, the data analyst is also blinded to randomization.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Cancer Research Center- Shahid Beheshti University of Medical Sciences
Street address
Cancer Research Center, Shohada-Tajrish Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Approval date
2024-03-10, 1402/12/20
Ethics committee reference number
IR.SBMU.CRC.REC.1402.034

Health conditions studied

1

Description of health condition studied
breast cancer skin lesion
ICD-10 code
C79.2
ICD-10 code description
Secondary malignant neoplasm of skin

Primary outcomes

1

Description
Assessment of patient recovery time with Aldrete score based on assessment of vital signs and consciousness
Timepoint
after operation
Method of measurement
Aldrete score

2

Description
neuropathic pain scale
Timepoint
before and after operation
Method of measurement
neuropathic pain scale

3

Description
Ramsay sedation scale
Timepoint
before, during and after operation
Method of measurement
Ramsay sedation scale

4

Description
Bispectral index
Timepoint
during operation
Method of measurement
Bispectral index sensor

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Propofol injection before electrochemotherapy, with a dose of 25 -75 macro/min/kg in breast cancer patients with skin metastasis who are candidates for electrochemotherapy
Category
Treatment - Drugs

2

Description
Intervention group: Dexmedetomidine injection before electrochemotherapy, first with a bolus dose of 0.5 to one macro/kg and then one-tenth to one macro/kg per hour, in breast cancer patients with skin metastasis who are candidates for electrochemistry
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Sogol Asgari
Street address
Loghman Hakim Hospital, Makhsus St ,Qazvin St ,Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
loghman.hospital@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
5th floor, Building No. 2, Shahid Arabi St., Yemen St., Shahid Chamran highway, Tehran
City
Tehran
Province
Tehran
Postal code
19395-4631
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sogol Asgari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Loghman Hakim Hospital, Makhsus St ,Qazvin St ,Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
drasgari98429@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sogol Asgari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Loghman Hakim Hospital, Makhsus St ,Qazvin St ,Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
drasgari98429@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sogol Asgari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Loghman Hakim Hospital, Makhsus St ,Qazvin St ,Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
drasgari98429@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the data, such as information on the main outcome, can be shared after de-identifying individuals
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document
-
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