Protocol summary

Study aim
The effect of dexmedetomidine on hemodynamics of patients and the average amount of isoflurane consumed by patients during laparoscopic cholecystectomy
Design
The trial should have a control group, with parallel, double-blind, randomized, phase 3 groups performed on 80 patients. A table of random numbers is used for randomization.
Settings and conduct
This study will be performed on patients undergoing laparoscopic cholecystectomy referred to Valiasr Hospital in Arak as a randomized clinical trial with a control group. This study is a two-way blind and patients will be blind, clinical caregiver and outcome assessor compared to the study groups and blinding will be done using placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate patients for laparoscopic cholecystectomy, age 18 to 65 years. Conditions of non-entry: do not undergo general anesthesia, cardiopulmonary disease, operation time more than 120 minutes
Intervention groups
In the dexmedetomidine group, for patients, 1 μg / kg of dexmedetomidine is placed in the form of a bolus, the volume of which has reached 20cc by normal saline, during induction of anesthesia on a syringe pump. They will then receive an infusion of 0.4 micrograms per kilogram per hour of dexmedetomidine during anesthesia. In the placebo group, 20cc of normal saline is placed on the syringe pump during induction and injected for patients. We will also put the equivalent of 50cc of normal saline, which is equal to the volume of dexmedetomidine used during anesthesia in the dexmedetomidine group, on the infusion pump.
Main outcome variables
Mean isoflurane consumption, mean systolic pressure, pulse rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210508051221N1
Registration date: 2021-05-16, 1400/02/26
Registration timing: prospective

Last update: 2021-05-16, 1400/02/26
Update count: 0
Registration date
2021-05-16, 1400/02/26
Registrant information
Name
Hesam Rezaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 2222 2003
Email address
hesam.rezaei72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Dexmedetomidine on hemodynamics of Patients and the Mean Rate of Isoflurane Consumption in Laparoscopic Cholecystectomy surgery
Public title
The effect of dexmedetomidine on hemodynamics of cholecystectomy patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for laparoscopic cholecystectomy Age 18 to 65 years
Exclusion criteria:
Patients who do not undergo general anesthesia People with cardiopulmonary disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study will be done using the random number table method. In this way,The main performer randomly selects one of the numbers in the table by determining the direction of movement and moves in the selected direction in order. Then, based on the numbers obtained, odd numbers will be assigned to group A and even numbers will be assigned to group B.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blindness in this study will be double blind. In this way, patients are not aware of the type of drug used and the study groups, and only the main performer is aware of the type of intervention and drugs used and prepares the drugs with labels A and B. Also, the clinical caregiver and outcome assessor are not aware of the study groups and recognize the groups based on the letters A and B.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2020-11-15, 1399/08/25
Ethics committee reference number
IR.ARAKMU.REC.1399.240

Health conditions studied

1

Description of health condition studied
Cholecystitis
ICD-10 code
K80.0
ICD-10 code description
Calculus of gallbladder with acute cholecystitis

Primary outcomes

1

Description
Hemodynamics of patients
Timepoint
15, 30, 45, 60 and 90 minutes after the start of surgery
Method of measurement
Based on pulse rate and mean systolic pressure

Secondary outcomes

1

Description
The amount of isoflurane consumed
Timepoint
From the beginning to the end of surgery
Method of measurement
check list

Intervention groups

1

Description
Intervention group: After induction of anesthesia, the mentioned patients are intubated and placed under a ventilator. For all the mentioned patients, isoflurane anesthesia will be used 1-2% per minute and then the surgeon will be allowed to start surgery and cholecystectomy. In the dexmedetomidine group, for patients, 1 μg / kg of dexmedetomidine (Imagen-Iran) is placed in the form of a bolus, the volume of which has reached 20cc by normal saline. They will receive dexmedetomidine as an infusion.
Category
Treatment - Drugs

2

Description
Control group: After induction of anesthesia, the mentioned patients are intubated and placed under a ventilator. For all the mentioned patients, isoflurane anesthesia will be used 1-2% per minute and then the surgeon will be allowed to start surgery and cholecystectomy. In the placebo group, 20 cc of normal saline is placed on the syringe pump during induction and injected for patients.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Hesam Rezaee
Street address
Valiasr Hospital
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
pr_valieasr@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hesam Rezaee
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hesam Rezaee
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hesam Rezaee
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.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
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