The aim of this study was to determine the effect of subcutaneous injection of naloxone to prevent itching is caused by intrathecal injection of pethedine. This study is a clinica lstage 3 trail double-blind, placebo-controlled, single center. 105 patient condidate 60-20 years who due to Inclusion criteria: Inclusion criteria: patients condidate spinal anesthesia , Exclusion criteria: the creation of any side effects of naloxone; any cardiovascular disease; Addiction to opioids randomly selected, divide into three groups of 35 people.The first group .5 ml of sterile saline , second and third group .01 mg per kg body weight naloxone that volume has been to half ml injected subcutaneously in the anterior forearmand after 5 minute , the first and the second group analgesic lidocaine .5% and pethedine a of the space L3-L4 lumbar and the third group of patients with analgesic lidocaine.5% and pethedine plus 0.1 mg adrenaline 0.001%, are under spinal anesthesia.check list are checked after surgery, itching is responding to treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021210222N8
Registration date:2017-03-04, 1395/12/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-03-04, 1395/12/14
Registrant information
Name
Zahra Keivani
Name of organization / entity
Shahrekord University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
keivani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University Of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of subcutaneous injection of naloxone to prevent pruritus caused of intrathecal injection of pethidine in minor surgeries
Public title
Study the effect of subcutaneous injection of naloxone to prevent pruritus caused of intrathecal injection of pethidine in minor surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients condidate spinal anesthesia using exclusion criteria: the creation of any side effects of naloxone any cardiovascular disease; Addiction to opioids
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
N/A
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 of Shahrekord University of Medical Sciences
Street address
shahrekord university of medical sciences, Kashani street, shahrekord
City
Shahrekord
Postal code
Approval date
2017-01-15, 1395/10/26
Ethics committee reference number
IR.SKUMS.REC.1395.249
Health conditions studied
1
Description of health condition studied
itching
ICD-10 code
L24.9
ICD-10 code description
Irritant contact dermatitis, unspecified cause
Primary outcomes
1
Description
itching
Timepoint
after surgery
Method of measurement
checklist
Secondary outcomes
empty
Intervention groups
1
Description
First Group:.5 ml of sterile normal saline is injected subcutaneously in the anterior forearm and after 5 minute with lidocaine.5% and pethedine from the fourth and fifth vertebrae of lumbar space under spinal anesthesi.
Category
Prevention
2
Description
Second group: 01.% mg per kg body weight naloxone that volume has been to.5 ml is injected subcutaneously in the anterior forearm andFirst Group:.5 ml of sterile normal saline is injected subcutaneously in the anterior forearm and after 5 minute with lidocaine.5% and pethedine from the fourth and fifth vertebrae of lumbar space under spinal anesthesi.
Category
Treatment - Drugs
3
Description
Third group:01.% mg per kg body weight naloxone that volume has been to.5 ml is injected subcutaneously in the anterior forearm and after 5 minute with lidocaine half a percent and pethedine plus 0.1% mg adrenaline 0.001% from the fourth and fifth vertebrae of lumbar space under spinal anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital in Shahrekord
Full name of responsible person
Mohammad Reza Abedinzadeh
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar street, shahrekord
City
shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahrekord University of Medical Science
Full name of responsible person
Dr. Kamal Solati
Street address
shahrekord university of medical sciences, Kashani street, shahrekord
City
Shahrekord
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 Shahrekord University of Medical Science
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
Shahrekord University Of Medical Sciences
Full name of responsible person
Mohammad Reza Abedinzadeh
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar street, shahrekord
City
Shahrekord
Postal code
Phone
+98 383322200016
Fax
Email
st-ahmadi.a@skums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Mohammad Reza Abedinzadeh
Position
Anesthesiologist, Associate Professor
Other areas of specialty/work
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar street, shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
st-ahmadi.a@skums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical
Full name of responsible person
Mohammad Reza Abedinzadeh
Position
Anesthesiologist, Associate Professor
Other areas of specialty/work
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar street, shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
st-ahmadi.a@skums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)