determining the effect of dexmedetomidine on blood sugar levels in patients undergoing discopathy surgery
Design
randomized،Two arm parallel group randomised trial with one-sided blind, phase 0 on 62 patients.
Settings and conduct
Operating room of Golestan hospital, blood sugar check at intervals of 0-10-30-60 and 10 minutes after the end of the operation by sampling with a lancet from the fingertip
Participants/Inclusion and exclusion criteria
People who undergo discopathy and do not have diabetes, heart, liver, kidney, or endocrine disease
Intervention groups
Determining the effect of dexmedetomidine on blood sugar
Determining the effect of dexmedetomidine on blood sugar levels in patients undergoing discopathy surgery
Public title
effect of dexmedetomidine on blood sugar levels in patients undergoing discopathy surgery
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
patients undergoing discopathy surgery
Exclusion criteria:
dibetic person
endocrine disorders
cardiovascular disease
liver disorders
kidney disorders
Age
No age limit
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
62
More than 1 sample in each individual
Number of samples in each individual:
5
check blood sugar
Randomization (investigator's opinion)
Randomized
Randomization description
Block
The method of assigning the intervention to patients is randomly and by the method of randomized permutation blocks with random block sizes of 4, 6 and 8 (using the table related to random permutations). The randomization list is prepared by a statistician. The intervention used in this research is allocated according to the randomized list by a person outside the study who is not aware of the research objectives and according to the corresponding codes in the sealed envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ahvaz jundi shapour university of medical sciences
Street address
esfand Ave,gulestan street,ahvaz,khuzestan
City
ahvaz
Province
Khouzestan
Postal code
6135733118
Approval date
2024-03-06, 1402/12/16
Ethics committee reference number
330101572
Health conditions studied
1
Description of health condition studied
dexmedetomidine
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The effect of dexmedetomidine drug on blood sugar of people undergoing discopathy surgery
Timepoint
before the start of the intervention and 10, 30, and 60 minutes after the operation and 10 minutes after the operation
Method of measurement
glucometr
Secondary outcomes
1
Description
blood sugar
Timepoint
at the beginning of the study and at 10, 30, 60 and 10 minutes after the end of the surgery
Method of measurement
glucometr
2
Description
BMI
Timepoint
Before surgery
Method of measurement
Based on the body mass index formula
3
Description
Pain level of patients after surgery
Timepoint
after surgery
Method of measurement
Visual Analogue Scale
4
Description
Hemodynamic
Timepoint
Before the intervention, during the operation and after the operation
Method of measurement
Measuring blood pressure with a sphygmomanometer
Intervention groups
1
Description
Intervention group: Dexmedetomidine , 0.1 mcg/kg/min, once at the beginning of surgery, intraoperative infusion
Category
Other
2
Description
Control group: Normal saline serum, 0.1 mcg/kg/min, received as intraoperative infusion
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
golestan hospital
Full name of responsible person
ali ghomeishi
Street address
golestan street,ahvaz,khuzestan
City
ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3320 4516
Email
saharsaadaati30@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
ali ghomeishi
Street address
golestan hospital.golestan street
City
ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3320 4501
Email
saharsaadaati30@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ahvaz jundishapur university of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
ali ghomeishi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
golestan hospital,golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3320 4501
Email
saharsaadaati30@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
ali ghomeishi
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
golestan hospital,golestan street
City
ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3320 4501
Email
saharsaadaati30@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
ali ghomeishi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
golestan hospital,golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3320 4501
Email
saharsaadaati30@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data is shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Allowed to use the results of the study for further investigation
From where data/document is obtainable
Email address
What processes are involved for a request to access data/document
After sending the message to the e-mail address, the data files will reach her for about 1 month