Protocol summary

Study aim
Determining the effect of two different doses of 1 and 0.75 (µg/kg) dexmedetomidine on the control of heart rate and blood pressure during the use of tourniquet in upper extremity surgery
Design
Clinical trial with control group, parallel groups, triple-blind, randomized, phase 3 on 90 patients Randomization with random allocation software
Settings and conduct
In Kashani hospital in Isfahan, under EKG monitoring, non-invasive blood pressure and pulse oximetry Dex group 1, 1 (µg/kg) dexmedetomidine induced within 10 minutes, continuation with 0.75 (µg/kg) Dex group 2, 1 (µg/kg) dexmedetomidine induced within 10 minutes, continuation with 1 (µg/kg) Saline group (control), normal saline infusion Identical syringes are used Induction of anesthesia using sodium thiopental 5 (mg/kg), fentanyl 3 (µg/kg), atracurium 0.6 (mg/kg) Maintenance of anesthesia using propofol 0.75 (min/µg/kg) and remifentanil 0.1 (min/µg/kg) Measurement and recording of systolic, diastolic, and mean arterial blood pressure, heart rate, and SpO2 at baseline and at 0, 10, 20, 30, 40, 50, and 60 minutes after inflating the tourniquet and right after emptying it The patient, the person who collects the data, and the statistician are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with ASA (American Society of Anesthesiologists) = 1, aged 18-65 years Exclusion criteria: drug addicts, people with a history of allergy to studied drugs, people with heart, liver and kidney failure, allergy to study drugs, change in anesthesia method, duration of tourniquet less than 60 or more than 150 minutes
Intervention groups
Three groups of 30 patients, dexmedetomidine 1 and 2 and the control group Dex group 1: dose 0.75 (µg/kg) of dexmedetomidine infusion Dex group 2: dose 1 (µg/kg) of dexmedetomidine infusion Control group: normal saline infusion
Main outcome variables
Heart rate; Blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090129001615N7
Registration date: 2023-05-13, 1402/02/23
Registration timing: prospective

Last update: 2023-05-13, 1402/02/23
Update count: 0
Registration date
2023-05-13, 1402/02/23
Registrant information
Name
Azim Honarmand
Name of organization / entity
Alzahra hospital
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
honarmand@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-21, 1402/02/31
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the preemptive effect of two different doses of dexmedetomidine on changes in blood pressure and heart rate following the use of a tourniquet during a randomized trial of upper extremity orthopedic surgery
Public title
Investigating the preemptive effect of two different doses of dexmedetomidine on changes in blood pressure and heart rate following the use of a tourniquet during a randomized trial of upper extremity orthopedic surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA (American Society of Anesthesiologists) = 1, aged 18-65 years, who are Patients aged 18-65 years Candidates for upper limb orthopedic surgery under tourniquet who undergo general anesthesia
Exclusion criteria:
Addicted people People with a history of allergy to the studied drugs People with heart, liver or kidney failure People with ASA = 2
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
It will be done using Random Allocation software. Patients are placed in three groups of 30, dexmedetomidine 1 and 2 and saline (control) group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient and the person collecting the study data are not aware of the study group. The statistician who analyzes the data will also include this requirement.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Soffeh st.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2023-03-14, 1401/12/23
Ethics committee reference number
IR.ARI.MUI.REC.1401.334

Health conditions studied

1

Description of health condition studied
Blood pressure
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Heart rate
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Blood pressure
Timepoint
At baseline times (before administration of study drugs) and then at times 0, 10, 20, 30, 40, 50 and 60 minutes after tourniquet inflation and then immediately after deflation
Method of measurement
Sphygmomanometer

2

Description
Heart rate
Timepoint
At baseline times (before administration of study drugs) and then at times 0, 10, 20, 30, 40, 50 and 60 minutes after tourniquet inflation and then immediately after deflation
Method of measurement
Electrocardiogram

3

Description
Oxygen saturation
Timepoint
At baseline times (before administration of study drugs) and then at times 0, 10, 20, 30, 40, 50 and 60 minutes after tourniquet inflation and then immediately after deflation
Method of measurement
Pulse oximeter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group one: In the dexmedetomidine 1 group, 1 (kg/µg) dexmedetomidine is infused within 10 minutes and then continued with a dose of 0.75 (kg/µg) dexmedetomidine infusion during the operation.
Category
Prevention

2

Description
Intervention group two: In the dexmedetomidine group 2, 1 (kg/µg) dexmedetomidine is infused within 10 minutes and then continued with a dose of 1 (kg/µg) dexmedetomidine infusion during the operation.
Category
Prevention

3

Description
Control group: In the control group, normal saline is infused.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Azim Honarmand
Street address
Kashani st.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3233 0091
Email
honarmand@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
gh_askari@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Azim Honarmand
Position
Anesthesiologist and special care specialist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 110 2327
Fax
Email
honarmand@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azim Honarmand
Position
Anesthesiologist and special care specialist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 110 2327
Fax
Email
honarmand@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azim Honarmand
Position
Anesthesiologist and special care specialist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 110 2327
Fax
Email
honarmand@med.mui.ac.ir
Web page address

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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