Comparison of the effect of dexmedetomidine and magnesium sulfate in controlling hemodynamic changes in patients undergoing laparoscopic cholecystectomy
The aim of this study was to evaluate the efficacy of dexmedetomidine and magnesium sulfate on hemodynamic responses during laparoscopic cholecystectomy.
Pneumoperitoneum as consequence of laparoscopic surgery would cause hemodynamic unstability. Effect of different medication on reduction unfavorable aspects of pneumoperitoneum is been reported. In this study, it was compared the efficacy of dexmedetomidine and magnesium sulfate on hemodynamic responses during laparoscopic cholecystectomy in Kashan Shahid Beheshti Hospital. The patients were divided into 3 groups in a random manner. In control group (C), normal saline was infused, Dexmedetomidine group (D) received 1µg/kg Dexmedetomidine and then 0.5µg/kg/hr and magnesium sulfate group (M) received 2 gr magnesium sulfate and then 0.9mg/kg/hr. Participants were unaware of which group they were in. The clinical caregiver recording the data was not aware of the type of patient group.
Participants/Inclusion and exclusion criteria
Population of study are sujects that candidate for laparoscopic gallbladder removal surgery. Inclusion criteria: patients Candidate for Laparoscopic Cholecystectomy Surgery in Kashan Shahid Beheshti Hospital,
patients 18-65 years, Level one and two class A.S.A (American society of anesthesiologists), Blood pressure less than or equal to 140/190
Intervention groups
In Dexmedetomidine (D) group, dexmedetomidine solution in normal saline, in magnesium sulfate (S) group, magnesium sulfate solution in normal saline and normal saline were as a placebo injected in the control group (C).
Main outcome variables
Systolic blood pressure; Diastolic blood pressure; Mean arterial blood pressure; Heart Rate; o2 saturation, Intra-abdominal pressure; End-Tidal CO2; Bispectral index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191220045829N1
Registration date:2021-09-27, 1400/07/05
Registration timing:retrospective
Last update:2021-09-27, 1400/07/05
Update count:0
Registration date
2021-09-27, 1400/07/05
Registrant information
Name
Reza ArefNezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 4372
Email address
arefnezhad@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2019-03-11, 1397/12/20
Trial completion date
2019-12-05, 1398/09/14
Scientific title
Comparison of the effect of dexmedetomidine and magnesium sulfate in controlling hemodynamic changes in patients undergoing laparoscopic cholecystectomy
Public title
Comparison of the effect of dexmedetomidine and magnesium sulfate in patients undergoing laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients Candidate for Laparoscopic Cholecystectomy Surgery in Kashan Shahid Beheshti Hospital
Patients 18-65 years
Level one and two class A.S.A (American society of anesthesiologists)
Blood pressure less than or equal to 140/190
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
75
Actual sample size reached:
61
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization was used to randomly assign people to three groups and to ensure that the number of people in groups is balanced. Participants randomly had been divided into three groups: dexmedomidine, magnesium sulfate, and control. One envelope was opened for each patient, each envelope had a random number. It had been predetermined that each random number belongs to one of the three groups mentioned.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants consented to participate in the study but were unaware of which group they were in. The clinical caregiver recording the data was not aware of the type of patient group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2016-11-16, 1395/08/26
Ethics committee reference number
IR.KAUMS.REC.1395.82
Health conditions studied
1
Description of health condition studied
Laparoscopic cholecystectomy
ICD-10 code
K80.2
ICD-10 code description
Calculus of gallbladder without cholecystitis
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
Before and after pre-drug injection, after induction, after intubation, after blowing gas, every 10 minutes up to 40 minutes and after extubation
Method of measurement
It was recorded by a monitor device attached to the patient.
2
Description
Diastolic blood pressure
Timepoint
Before and after pre-drug injection, after induction, after intubation, after blowing gas, every 10 minutes up to 40 minutes and after extubation
Method of measurement
It was recorded by a monitor device attached to the patient.
3
Description
Mean arterial blood pressure
Timepoint
Before and after pre-drug injection, after induction, after intubation, after blowing gas, every 10 minutes up to 40 minutes and after extubation
Method of measurement
It was recorded by a monitor device attached to the patient.
4
Description
Heart Rate
Timepoint
Before and after pre-drug injection, after induction, after intubation, after blowing gas, every 10 minutes up to 40 minutes and after extubation
Method of measurement
It was recorded by a monitor device attached to the patient.
5
Description
o2 saturation
Timepoint
Before and after pre-drug injection, after induction, after intubation, after blowing gas, every 10 minutes up to 40 minutes and after extubation
Method of measurement
Pulse oximtery
6
Description
Intra-abdominal pressure
Timepoint
every 10 minutes up to 40 minutes
Method of measurement
Manometer
7
Description
End-Tidal CO2
Timepoint
Before and after pre-drug injection, after induction, after intubation, after blowing gas, every 10 minutes up to 40 minutes and after extubation
Method of measurement
Capnograph device
8
Description
Bispectral index
Timepoint
Before and after pre-drug injection, after induction, after intubation, after blowing gas, every 10 minutes up to 40 minutes and after extubation
Method of measurement
It was recorded by a monitor device attached to the patient.
Secondary outcomes
1
Description
Recovery time
Timepoint
From the the rejection of patient's endotracheal intubation to the number 9 of the Aldrete criteria
Method of measurement
Aldrete criteria
2
Description
Rate of usage of Propofol
Timepoint
One time at the end of surgery
Method of measurement
The mean dose per kilogram of body weight per minute
Intervention groups
1
Description
Intervention group: Dexmedetomidine 1µg/kg was injected intravenously in 20 ml normal saline for ten minutes before induction of anesthesia, and dexmedetomidine 0.5µg/kg per hour after induction of it.
Category
Prevention
2
Description
Intervention group: Before induction of anesthesia, 4ml magnesium sulfate 50% (2gr) was infused in 20 ml normal saline for ten minutes and after induction of it, magnesium sulfate 50% (0.9mg/kg) was infused intravenously per hour.
Category
Prevention
3
Description
Control group: Normal saline was injected intravenously in 20 ml volume for ten minutes before and after induction of anesthesia.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan shahid beheshti hospotal
Full name of responsible person
مهدی رجبی
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Email
beheshtihospital@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 2999
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Emad Khan ahmad
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0026
Email
reza.2240power@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mehdi Rajabi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0026
Email
Rajabi_mahdi@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Reza ArefNezhaad
Position
MSc student of anatomy
Latest degree
Bachelor
Other areas of specialty/work
Anatomy
Street address
zand avenue
City
shiraz
Province
Fars
Postal code
۱۴۳۳۶ ۷۱۳۴۸
Phone
+98 71 3230 4372
Email
reza.aref1374@gmail.com
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