The effect of Marcaine / Dexmedetumidine versus Marcaine / Fentanyl on the sensory motor block in unilateral spinal anesthesia of patients undergoing lower limb orthopedic surgery
comparison the effect of Marcaine / Dexmedetumidine versus Marcaine / Fentanyl on the sensory motor block in unilateral spinal anesthesia of patients undergoing lower limb orthopedic surgery
Design
Patients will be randomized (randomized list with PASS software) divided into two groups of BF and BD.
Each group consists of 18 patients.
In the BF group, marcaine and fentanyl are used, and in the BD group, marcaine and dexmedmoedine are used for unilateral spinal anesthesia.
Settings and conduct
This randomized clinical trial was performed on 36 patients undergoing unilateral orthopedic surgeries in one of the patients at Ghaem Hospital in Mashhad, Iran.
In the group BF; mg7.5 marcaine (0.5% hyperbaric) and fentanyl 10 μg and in the BD group; 7.5 mg marcaine(0.5% hyperbaric) and 5 mg dexmedetomidine will be injected
Participants/Inclusion and exclusion criteria
Patients with ASA class I and II who were older than 18 years old entered to the study
patients who had high intracranial pressure, infection in the site of block , coagulopathy, corticospinal tract disease , sensory-disabling diseases, neuropathy, and a history of discopathy were excluded.
Intervention groups
The effect of Marcaine / Dexmedetumidine versus Marcaine / Fentanyl on the sensory motor block in unilateral spinal anesthesia
Main outcome variables
The duration of the sensory-motor block (min); The onset of the effect of the sensory-motor block (min); the frequency of urinary retention; the hemodynamic status (heart rate, systolic and diastolic blood pressure); the frequency of nausea and vomiting; The frequency of itching
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190510043545N1
Registration date:2019-08-14, 1398/05/23
Registration timing:retrospective
Last update:2019-08-14, 1398/05/23
Update count:0
Registration date
2019-08-14, 1398/05/23
Registrant information
Name
seyed javad purafzali firuzabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3728 2267
Email address
sjvdpurafzali@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Marcaine / Dexmedetumidine versus Marcaine / Fentanyl on the sensory motor block in unilateral spinal anesthesia of patients undergoing lower limb orthopedic surgery
Public title
The effect of Marcaine / Dexmedetumidine versus Marcaine / Fentanyl on the sensory motor block in unilateral spinal anesthesia of patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for the unilateral lower limb orthopedic surgery and at least 18 years old
ASA class I,II
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized (randomized list with PASS software) divided into two groups of BF and BD.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blind study. Patients are not aware of the type of drug used, and the person who are checked the symptoms does not know the type of medication.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghoreishi building , Daneshgah ave , Mashhad , Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2016-07-13, 1395/04/23
Ethics committee reference number
ir.mums.rec 1395.285
Health conditions studied
1
Description of health condition studied
unilateral spinal anesthesia of patients undergoing lower limb orthopedic surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The duration of the sensory-motor block (min);
Timepoint
Every 5 minutes to 30 minutes and then every 15 minutes until the end of the operation is recorded. In the recovery, it is recorded at the time of entry and every 15 minutes until complete removal of the sensory motor block.
Method of measurement
Check motor level based on bromage scale and sensory level with pin prick test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the BD group, Marcaine and Dexmedetomedine are used for unilateral spinal anesthesia.
Category
Treatment - Drugs
2
Description
Control group: Control group: In the BF group, marcaine and fentanyl are used for unilateral spinal anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital , Mashhad , Iran
Full name of responsible person
Mohamad Alipour
Street address
Ahmad Abad Blvd , Mashhad , Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
sjvdpurafzali@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
ِDaneshgah Blvd , Mashhad , Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9919191778
Phone
+98 51 3804 9051
Email
tafaghodim@mums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohamad Alipour
Position
Associate professor of anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ahmad Abad Blvd , Mashhad , Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
sjvdpurafzali@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohamad Alipour
Position
Associate professor of anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ahmad Abad Blvd , Mashhad , Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
sjvdpurafzali@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Javad Purafzali Firuzabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Yaqut6 , Shahid sadeqi27 ave, Mashhhad , Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9184993477
Phone
+98 51 3728 2267
Fax
Email
sjvdpurafzali@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Individual data of the participants after the collection and analysis is published as a article and report.
When the data will become available and for how long
Since 2019 and after the publication of the results
To whom data/document is available
All people who need our study results.
Under which criteria data/document could be used
For further studies, they can use the results of this study.