Comparison of the effect of dexmedetomidine and propofol on laboratory parameters of patients with secondary hyperparathyroidism caused by uremia in parathyroidectomy surgery
Choosing the best method for anesthesia induction is parathyroidectomy surgery.
Design
A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 60 patients. IZE Android software is used for randomization and the output of the software introduces the patient as group A and B.
Settings and conduct
Patients with secondary hyperparathyroidism caused by uremia referred to Tajrish Hospital who are candidates for elective parathyroidectomy surgery in a blinded study so that only the numbers A and B are written on the form in the patient's hand, and as a result, the patient is informed about the entered group. They are not participating in the study. : propofol and dexmedetomidine:
In the first group, propofol will be administered as bolus for induction and then infusion with isoflurane gas during the operation and will be stopped about 30 minutes before the end of the surgery.
In the second group, DEX will be administered as a bolus 10 minutes before the induction and then the infusion with isoflurane gas will be administered during the operation and will be stopped about 30 minutes before the end of the surgery.
.
Participants/Inclusion and exclusion criteria
Ages 18 to 80 years, ASA class 2 and secondary hyperparathyroidism were included in the study and primary or tertiary hyperparathyroidismand ASA class 1 and 3 and above were excluded from the study.
Intervention groups
DEX as a bolus 10 minutes before induction and then infusion r with isoflurane gas. MAC will be administered during the operation and will be stopped about 30 minutes before the end of the surgery.
Main outcome variables
The resulting information such as serum concentration of calcium, phosphorus, iPTH and ESR and hemodynamic indicators including blood pressure, heart rate, oxygen level saturation of the patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190121042444N6
Registration date:2024-09-04, 1403/06/14
Registration timing:registered_while_recruiting
Last update:2024-09-04, 1403/06/14
Update count:0
Registration date
2024-09-04, 1403/06/14
Registrant information
Name
faranak behnaz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1174
Email address
faranak.behnaz@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-08-10, 1403/05/20
Expected recruitment end date
2026-08-11, 1405/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of dexmedetomidine and propofol on laboratory parameters of patients with secondary hyperparathyroidism caused by uremia in parathyroidectomy surgery
Public title
Investigating the effect of dexmedetomidine and propofol on hemodynamic and laboratory parameters of patients with secondary hyperparathyroidism caused by uremia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 18 to 80 years
ASA class 2 who is a candidate for parathyroidectomy surgery
Secondary hyperparathyroidism
Elective surgery
Exclusion criteria:
Primary or tertiary hyperparathyroidism
History of previous thyroid surgery
Operation performed by any other surgeon
Incomplete anesthesia or surgery records
ASA class 1 and 3 and above
Emergency surgery
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The participants in the study are divided into two groups, control and intervention, using a randomizer software, so that at first, each patient is given a number by the researcher, and it is entered into the IZE Android software, and the output of the patient software is as It introduces groups A and B.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are introduced to the data collector to continue the study so that only the numbers A and B are written on the form in the patient's hand, and as a result, the patient and the data collector are not aware of the patient group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Behesti University of Medical Sciences
Street address
Yaman Ave,Velenjak
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2024-07-31, 1403/05/10
Ethics committee reference number
IR.SBMU.MSP.REC.1403.231
Health conditions studied
1
Description of health condition studied
Secondary hyperparathyroidism
ICD-10 code
N25.81
ICD-10 code description
Secondary hyperparathyroidism of renal origin
Primary outcomes
1
Description
Blood pressure
Timepoint
Before the intervention, 15 minutes during the operation and 30 minutes after the operation
Method of measurement
Automatic pressure gauge
2
Description
Heart rate
Timepoint
Before the intervention, 15 minutes during the operation and 30 minutes after the operation
Method of measurement
Monitoring
3
Description
Oxygen saturation percentage
Timepoint
Before the intervention, 15 minutes during the operation and 30 minutes after the operation
Method of measurement
Monitoring
4
Description
Urea
Timepoint
Before the intervention and one hour after the operation
Method of measurement
Measurement of serum levels in a blood test
5
Description
Creatinine
Timepoint
Before the intervention and one hour after the operation
Method of measurement
Measurement of serum levels in a blood test
6
Description
ESR
Timepoint
Before the intervention and one hour after the operation
Method of measurement
Percentage measurement in blood test
7
Description
Calcium
Timepoint
Before the intervention and one hour after the operation
Method of measurement
Measurement of serum levels in a blood test
8
Description
Phosphorus
Timepoint
Before the intervention and one hour after the operation
Method of measurement
Measurement of serum levels in a blood test
9
Description
Parathormone hormone
Timepoint
Before the intervention and one hour after the operation
Method of measurement
Measurement of serum levels in a blood test
10
Description
Bispectral Index
Timepoint
Before the intervention, 15 minutes during the operation and 30 minutes after the operation
Method of measurement
monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, dexmedetomidine as a bolus of 0.5 to 1 μg/kg for 10 minutes before induction and then infusion of 0.3 to 0.5 μg/kg per hour with 5/ isoflurane gas. MAC will be administered during the operation and will be stopped about 30 minutes before the end of the surgery. It should be noted that for group, the depth of anesthesia monitoring was recorded by the BIS device, and muscle relaxants and narcotics are routinely prescribed during the operation. And the concentration Serum calcium, phosphorus, iPTH and ESR before and after the operation, and hemodynamic indicators including blood pressure, heart rate, oxygen level saturation will be recorded before induction and every 15 minutes during anesthesia and every 30 minutes during recovery.
Category
Treatment - Drugs
2
Description
Control group: In this group, propofol drug in the form of a bolus of 1 to 2.5 mg/kg for induction and then infusion of 50 to 200 micrograms/kg per hour and with isoflurane 5/5 gas. mac is prescribed during the operation and will be stopped about 30 minutes before the end of the surgery. For the monitoring group, the depth of anesthesia is recorded by the BIS device and during the operation, muscle relaxants and narcotics are routinely prescribed. And the serum concentration of calcium, phosphorus, iPTH and ESR before and after the operation, and hemodynamic indicators, which include blood pressure, heart rate, oxygen level saturation, will be recorded before induction and every 15 minutes during anesthesia and every 30 minutes during recovery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Faranak Behnaz
Street address
Shohada Hospital,Tajrish SQ ,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
Shohada Tajrish Hosp
Phone
+98 21 2274 1174
Email
faranak.behnaz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nahid Asadi
Street address
Yaman AVE, Velenjak
City
Tehran
Province
Tehran
Postal code
1467664961
Phone
+98 21 2243 2572
Email
nahidasadi@yahoo.com
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
Faranak Behnaz
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shohada Hospital, Tajrish SQ, Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2274 1174
Email
faranak.behnaz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Padideh Ansar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shohada Hospital, Tajrish SQ, Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2274 1174
Email
padideh.ansar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faranak Behnaz
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shohada Hospital,Tajrish SQ
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2274 1174
Email
faranak.behnaz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the main consequence or the like, can be shared.
When the data will become available and for how long
Beginning of the access period from 1405
To whom data/document is available
Only for researchers in academic and scientific institutions