The aims of this study included: compare of mean the amount of pain after surgery based VAS in the two groups of study in defined times, compare of mean the amount of Analgesic use in patients in first 24 h in the two groups of study and compare of The mean time to completion of the operation the patient's first request for pain medication in the two groups of study.This double-blind study randomly assigned to two groups(case & control) with 128 participant. Inclusion criteria is:18-45 years old and ASA Class 1&2.exclusion criteria is : A history of cardiovascular disease, asthma, diabetes, kidney or liver disease or any systemic disease. Patients are transferred to the operating room for surgery And placed under spinal anesthesia with a uniform approach. In all cases the patient in the sitting position solution provided worked through the spinal needle numbers 25 Will be administered by an anesthesiologist on duty. Case group receive Bupivacaine (2.5cc) plus 5mg Dexmedetomidine(0.5cc) and control group receive Bupivacaine (2.5cc) plus Saline (0.5cc).assumed pain in times 1،2،6،12 ,24 after operating, The amount of Narcotic administration 24 hour after operating And time to first analgesic administration And assessed side effects are dry mouth, nausea, vomiting.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112430808N2
Registration date:2017-02-13, 1395/11/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-13, 1395/11/25
Registrant information
Name
Yousef Hosseini
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 816 6606
Email address
y.hosseini@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Jahrom university of Medical Science
Expected recruitment start date
2015-09-19, 1394/06/28
Expected recruitment end date
2016-09-18, 1395/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesia with and without the addition of Dex Methomedin to bupivacaine spinal anesthesia for orthopedic surgery using TOTAL KNEE
Public title
Comparison of analgesia with and without the addition of Dex Methomedin to bupivacaine spinal anesthesia for orthopedic surgery using TOTAL KNEE
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: aged 18 to 45 years old, Class 1 and 2 ASA
Exclusion Criteria:A history of cardiovascular disease, asthma, diabetes, kidney or liver disease or any systemic disease.History of narcotics, alcohol, anti-epileptic drugs, antipsychotic, analgesic.Patients who have severe pain during surgery and general anesthesia are forced to use
Age
From 18 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Cohen table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of jahrom University of Medical Sciences
Street address
Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran Jahrom
City
جهرم
Postal code
Approval date
2016-10-05, 1395/07/14
Ethics committee reference number
IR.JUMS.REC.1395.060
Health conditions studied
1
Description of health condition studied
Analgesia after surgery
ICD-10 code
R52
ICD-10 code description
Acute pain
Primary outcomes
1
Description
pain score
Timepoint
in 1,2,6,12,24 hour post operation
Method of measurement
pain assessment ruler
Secondary outcomes
1
Description
Blood pressure
Timepoint
1،2،6،12, 24 hours after surgery
Method of measurement
Blood pressure measuring device
2
Description
Pulse rate
Timepoint
1،2،6،12, 24 hours after surgery
Method of measurement
Pulse oximertry
3
Description
The Chills, oral dryness, nausea and vomiting
Timepoint
1،2،6،12, 24 hours after surgery
Method of measurement
use of a questionnaire researcher
4
Description
The rate of post-operative pain medication use
Timepoint
1،2،6،12, 24 hours after surgery
Method of measurement
total dose administered by injection(mg)
Intervention groups
1
Description
case group received 2.5 bupivacaine plus0.5 Dax medetomidine
Category
Treatment - Drugs
2
Description
control group received 12.5 bupivacaine ml plus 2.5 normal saline
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
peymanieh Hospital
Full name of responsible person
Navid Kalani
Street address
Jahrom University Of Medical University
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of jahrom University of Medical Sciences
Full name of responsible person
Kavoos Solhjo
Street address
Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran Jahrom
City
jahrom
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 of jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
navid kalani
Position
clerk
Other areas of specialty/work
Street address
Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran Jahrom
City
jahrom
Postal code
Phone
+98 7157414846199
Fax
Email
navidkalani@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Anesthesiology
Full name of responsible person
navid kalani
Position
Bachelor
Other areas of specialty/work
Street address
Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran Jahrom
City
jahrom
Postal code
Phone
+98 7157414846199
Fax
Email
navidkalani@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
navid kalani
Position
clerk
Other areas of specialty/work
Street address
Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran Jahrom
City
jahrom
Postal code
Phone
+98 7157414846199
Fax
Email
navidkalani@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)