Effect of intravenous infusion of dexmedetomidine with magnesium sulfate on control of bleeding and surgeon satisfaction during tympanoplasty surgery: a double-blind randomized clinical trial
To assess the effect of intravenous infusion of dexmedetomidine with magnesium sulfate on control of bleeding and surgeon satisfaction during tympanoplasty surgery
Design
This is a double-blind randomized clinical trial with comparison group, phase III, in which 40 eligible patients will be randomly assigned through the block randomization to the intervention groups
Settings and conduct
This study will be performed in the Besat Hospital in Hamadan city on 40 candidates for tympanoplasty surgery. The patients will be randomly assigned to the intervention groups through the block randomization. This trial will be double -blinded so that neither the patients not the examiner will be aware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 61 years
Candidate patients for tympanoplasty
Exclusion criteria:
Pregnancy
Coagulation disorders
Acute or chronic renal failure
Liver failure
Neuromuscular diseases
Cardiovascular diseases
Intervention groups
Intervention group 1:
Intravenous infusion of dexmedetomidine at a dose of 1 μg/kg within 15 minutes
Intervention group 2:
Intravenous infusion of magnesium sulfate at a dose of 40 mg/kg within 15 minutes
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-05, 1401/03/15
Expected recruitment end date
2023-03-06, 1401/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous infusion of dexmedetomidine with magnesium sulfate on control of bleeding and surgeon satisfaction during tympanoplasty surgery: a double-blind randomized clinical trial
Public title
Effect of intravenous infusion of dexmedetomidine with magnesium sulfate on control of bleeding and surgeon satisfaction during tympanoplasty surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 61 years
Candidate patients for tympanoplasty
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention 1 and on the other two sheets the name of the intervention 2. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-05-07, 1401/02/17
Ethics committee reference number
IR.UMSHA.REC.1401.129
Health conditions studied
1
Description of health condition studied
Perforation of tympanic membrane
ICD-10 code
H72
ICD-10 code description
Perforation of tympanic membrane
Primary outcomes
1
Description
Intraoperative bleeding volume
Timepoint
َََAfter surgery
Method of measurement
By measuring the volume of the suction bottle (after deducting the volume of normal saline used)
2
Description
Surgeon satisfaction
Timepoint
After surgery
Method of measurement
Using 5-point Likert scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Intravenous infusion of dexmedetomidine at a dose of 1 μg/kg within 15 minutes
Category
Treatment - Drugs
2
Description
Intervention group 2: Intravenous infusion of magnesium sulfate at a dose of 40 mg/kg within 15 minutes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Mohammad Khajavi
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mohamad2khajavi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Khajavi
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mohamad2khajavi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Elnaz Shariatpanahi
Position
ENT Specialist
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
el.shariatpanahi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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