Protocol summary

Summary
The aim of this single-blind clinical trial study was to evaluate of axillary perineural injection of dexmedetomidine on hemodynamic factors during surgery and post-operative pain in patients undergoing upper orthopedic surgery in Shahid Beheshti Hospital, Kashan. Inclusion criteria including patients aged between 18 and 65 years, ASA class I, II, Fracture of the forearm and hands bones, BMI ≤ 35 and Patient consent form for study participation and exclusion criteria including Pregnancy, addiction, history of use of agonist or 2α adrenergic antagonist's drugs, coagulation disorders, hypersensitivity to intraoperative drugs and prolonged surgery for more than 120 minutes. Samples were randomly divided into two groups of 30 individuals in intervention and control groups. Patients will receive premedication of 0.05mg/kg Midazolam and 3μ/kg Fentanyl. The intervention group 100 μg Dexmedmotidine infusion in the auxiliary and pre- neural region. No injections was used in the control group. Induction was carried out by using 5mg/kg Sodium thiopental and 0.5 mg/kg atracurium. BIS is maintained in the range of 40 to 60 during the operation. At the end of surgery, all patients were reversed by 30μ/kg Atropine and 50μ/kg Neostigmine injections. Vital sign changes were recorded prior to the induction and every 15 minutes during the surgery. Postoperative pain was evaluated in recovery and 3, 6, 12 and 24 hours after surgery using VAS scale. Drug intake was recorded in the recovery and 24 hours after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017050833860N1
Registration date: 2017-11-01, 1396/08/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-11-01, 1396/08/10
Registrant information
Name
Abas Arshia
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 2999
Email address
arshia-a@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of axillary perineural injection of dexmedetomidine on hemodynamic changes during the surgical operation and post-operative pain in patients udergoing orthopedic upper extremity surgery
Public title
Effect of axillary perineural injection of dexmedetomidine on hemodynamic changes during the surgical operation and post-operative pain in patients udergoing orthopedic upper extremity surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Age 18-65, ASA 1, 2, Fracture of the forearm and hands bones, BMI ≤ 35 and Patient consent form for study participation. exclusion criteria:Pregnancy, addiction, history of use of agonist or 2α adrenergic antagonist's drugs, coagulation disorders, hypersensitivity to intraoperative drugs and prolonged surgery for more than 120 minutes.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Approval date
2017-07-17, 1396/04/26
Ethics committee reference number
IR.KAUMS.MEDNT.REC.16

Health conditions studied

1

Description of health condition studied
Fracture of forearm
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Systolic blood pressure
Timepoint
Before induction and every 15 minutes during surgery
Method of measurement
Monitoring device

2

Description
Diastolic blood pressure
Timepoint
Before induction and every 15 minutes during surgery
Method of measurement
Monitoring device

3

Description
Heart rate
Timepoint
Before induction and every 15 minutes during surgery
Method of measurement
Monitoring device

4

Description
Postoperative pain
Timepoint
At recovery, 3, 6, 12 and 24 hours after surgery
Method of measurement
visual analogue scale

5

Description
Drug use
Timepoint
In the recovery and the first 24 hours after surgery
Method of measurement
Injection dose based on mg

Secondary outcomes

empty

Intervention groups

1

Description
]intervention group: 100 μg Dexmedmotidine infusion in the auxiliary and pre- neural region.Induction was carried out by using 5mg/kg Sodium thiopental and 0.5 mg/kg atracurium.
Category
Treatment - Drugs

2

Description
Control group: No injections was used.Induction was carried out by using 5mg/kg Sodium thiopental and 0.5 mg/kg atracurium.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Street address
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mehdi Rajabi
Position
Assistant Anesthesiologist
Other areas of specialty/work
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Phone
+98 31 5554 0026
Fax
Email
rajabimmh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Abass Arshia
Position
Assistant Anesthesiologist
Other areas of specialty/work
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Phone
+98 31 5554 0026
Fax
Email
arshia-a@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arshia
Full name of responsible person
Abass
Position
Assistant Anesthesiologist
Other areas of specialty/work
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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