Protocol summary

Summary
Aim of this study is to compare of intravenous Dexmedetomidine and Clonidine in ‎change of ‎hemodynamic parameter and block quality after spinal anesthesia with ‎‎Ropivacaine in lower limb orthopedic surgery. This study clinical trials and double ‎blind. We will enter 120 patients with spinal anesthesia in lower limb orthopedic ‎surgery in Valiasr hospital. We will inject 0.1 Dexmedetomidine micro gram in ‎kilogram in hours in first group and 0.2 Clonidine micro gram in kilogram in hours ‎in second group and 50 milliliter in litter normal salin. We will record blood ‎pressure and heart rate and oxygen saturation percent in duration surgery every ‎‎15 minute. We will sensory block every 1 minute with pin prick method and ‎motor block every 5 minute with Bromeg scale. We will record visual analog scale ‎in recovery and 1 and 2 and 4 and 6 and 12 hours after surgery. Patient refusal to ‎perform spinal anesthesia;‏‎ failure to perform spinal anesthesia;‏‎ body mass index ‎more than 30‎‏;‏‎ history of the use of beta-blockers and alpha-2 agonists and ‎calcium channel blockers‏;‏‎ cardiovascular disease;‏‎ pregnancy; ‏coagulation disorders; localized infection in the spinal cord ;history of allergy to ‎the drugs of dexmeditoimidine and clonidine and rupivacaine‏;‏‎ arrhythmia;‏‎ ‎psychological problems;‏‎ peripheral and central neuropathy

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017092020258N60
Registration date: 2017-10-28, 1396/08/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-28, 1396/08/06
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Arak University of Medical Sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2020-03-12, 1398/12/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous Dexmedetomidine and Clonidine in change of ‎hemodynamic parameter and block quality after spinal anesthesia with ‎Ropivacaine in lower limb orthopedic surgery
Public title
Comparison of intravenous Dexmedetomidine and Clonidine in change of ‎hemodynamic parameter and block quality after spinal anesthesia with ‎Ropivacaine in lower limb orthopedic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18 to 60 years; ASA class I and II; both male and female; patients with lower limb orthopedic surgery Exclusion criteria: Patient refusal to perform spinal anesthesia;‏‎ failure to perform spinal anesthesia;‏‎ ‎body mass index more than 30‎‏;‏‎ history of the use of beta-blockers and alpha-2 ‎agonists and calcium channel blockers;‏‎ cardiovascular disease;‏‎ pregnancy ‏; ‏coagulation disorders; localized infection in the spinal cord ;history of allergy to ‎the drugs of dexmeditoimidine and clonidine and rupivacaine‏;‏‎ arrhythmia;‏‎ ‎psychological problems;‏‎ peripheral and central homeopathy
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2017-03-12, 1395/12/22
Ethics committee reference number
IR.ARAKMU.REC.1395.450

Health conditions studied

1

Description of health condition studied
Spinal
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia

Primary outcomes

1

Description
Blood pressure
Timepoint
Every 15 minute to end of surgery
Method of measurement
Barometer

2

Description
Heart rate
Timepoint
Every 5 minute to end of surgery
Method of measurement
Count

3

Description
Oxygen saturation
Timepoint
Every 15 minute to end of surgery
Method of measurement
Percent

4

Description
Sensory block
Timepoint
Every 1 minute
Method of measurement
Pin prick method ‎

5

Description
Motor block
Timepoint
Every 5 minute
Method of measurement
Bromeg scale

6

Description
Pain
Timepoint
In recovery and 1 and 2 and 4 and 6 and 12 hours after surgery‎
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
intervention group 2: We will inject Clonidine 0/2 micro gram in kilogram in hours.
Category
Treatment - Drugs

2

Description
Control group: We will inject 50 millimeter in litter normal salin.
Category
Treatment - Drugs

3

Description
intervention group 1: We will inject Dexmedetomidine 0/1 micro gram in kilogram in hours
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Alireza Sosanabadi
Street address
Valiasr Hospital, Shahid Shirodi street, Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Dr Anoshirvani
Street address
Vice chancellor for Research, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
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, Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamodin Modir
Position
Faculty member
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr square, Shahid Shirodi street
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
modir.he@gmail.com
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Sosanabadi
Position
Faculty member, Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr Squre, Shahid Shirodi Street
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
sosanabadi@arakmu.ac.ir
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Maryam Javahertalab
Position
Resident of anesthesiology
Other areas of specialty/work
Street address
Payambar Azam Complex, Basij Square, Sardasht, Arak
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
javahertalab@arakmu.ac.ir
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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