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Effect of magnesium sulfate on induced opiate- withdrawal syndrome

Protocol summary

Study aim
Effect of magnesium sulfate on induced opiate- withdrawal syndrome
Design
A randomized, double blind, placebo controlled clinical trial with a parallel group design of 40 patients with induced opiate withdrawal syndrome . Treatment group will receive MgSo4 in addition of usual recommended treatment (clonidine, Benzodiazepine , Apotel)
Settings and conduct
We compare the opiate withdrawal score at 0, 0.5 and 2 hours on both groups o patients were reffed to Emam Reza Hospital of Mashhad We also record the total doses of administrated drugs (clonidine, Benzodiazepine ), demographic variables and some confusing variables such as: kind and doses of antagonist, history of drug use (duration, type and the last dose), the time interval between use of antagonist or partial agonists and start of treatment.
Participants/Inclusion and exclusion criteria
All patient with Induced opiate withdrawal syndrome exclusion criteria: Naloxane treated, Ischemic heart disease, renal failure, hepatic failure, uncontrolled hypertension, Patients with long-term treatment with calcium receptor antagonists,allergy to magnesium compounds, Patients who have a history of concomitant use of other substances such as methamphetamine, alcohol or other stimulants , Patients with asthma, patients with Diabetic neuropathy, In case of incomplete registration ,Lack of patient collaboration and patient inaccessibility (in providing required information)
Intervention groups
Treatment group , Will be treated by 3 gram MgSo4 through 20 minutes intravenously that will be continued by 10 mg/kg/hours MgSo4 up to appropriate response or 3 hours
Main outcome variables
The opiate withdrawal score ; total doses of administrated drugs (clonidine, Benzodiazepine ).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190207042648N1
Registration date: 2019-05-22, 1398/03/01
Registration timing: registered_while_recruiting

Last update: 2019-05-22, 1398/03/01
Update count: 0
Registration date
2019-05-22, 1398/03/01
Registrant information
Name
Mohammad Moshiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3878 2615
Email address
moshirimo@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of magnesium sulfate on induced opiate- withdrawal syndrome
Public title
Effect of magnesium sulfate on induced opiate- withdrawal syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with Induced opiate withdrawal syndrome
Exclusion criteria:
Naloxane induced withdrawal Ischemic heart disease renal failure Hepatic failure Uncontrolled hypertension. AIDS Cerebrovascular disease long-term treatment with calcium Chanel blocker Diabetic neuropathy. Allergy to magnesium compounds Concomitant use of other substances such as methamphetamine, alcohol or other stimulants Asthma. In case of incomplete registration ,Lack of patient collaboration and patient inaccessibility (in providing required information) Pregnancy
Age
From 14 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be divided two groups by simple individual randomization method . When a patients referred to ED will be divided into groups by sealed envelops .
Blinding (investigator's opinion)
Double blinded
Blinding description
The precipitants will be blinded about the treatment. Researcher tells them " you will treat by a infusion of MgSO4 or normal saline". The evaluators will be blinded on the groups treatment. Others( researcher, analyzer and person responsible for patient care) know the groups
Placebo
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
Ghorash bulding, Danshghah street,
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2019-04-07, 1398/01/18
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.012

Health conditions studied

1

Description of health condition studied
withdrawal of opiate
ICD-10 code
F11.3
ICD-10 code description
Mental and behavioural disorders due to use of opioids withdrawal state

Primary outcomes

1

Description
Opiate withdrawal score
Timepoint
at start and 0.5 and 2 hours after treatment
Method of measurement
By Opiate withdrawal scale

2

Description
MG serum level
Timepoint
start and after 2 hours
Method of measurement
MG serum level

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: patients with induced opiate withdrawal. they will treated by magnesium sulfate 3gr Iv Infusion in 20 min stat & 10 mg/kg/h Iv Infusion for 3 hours in addition standard therapy.
Category
Treatment - Drugs

2

Description
Control group: patients with induced opiate withdrawal. they receive Tab clonidine 0.2 mg q1h up to 0.8 mg if SBP> 100 mmhg / Amp Diazepam 10 mg q15 min IV slowly up to 30 mg /Amp Apotel 1gr Iv in 200 cc serum N/s in 20 min
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
اورژانس مسمومین بیمارستان امام رضا مشهد
Full name of responsible person
Mohammad Moshiri
Street address
Ebnesina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Fax
+98 51 3854 3031
Email
Moshirimo@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafagodi
Street address
Daneshgah street Ghorashi building
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3841 1538
Fax
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Web page address
http://v-research.mums.ac.ir/index.php/component/content/article/62-vcresearch/514-tell
Grant name
Dr Mohsen Ebrahimi
Grant code / Reference number
970572
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
Mohammad Moshiri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
ٍEbnesina Street , Emam Reza Hospital , Clinical toxicology department
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2515
Fax
+98 51 3802 2515
Email
Moshirimo@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Moshiri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
ٍDepartment of clinical toxicology ,Emam Reza hospital , Ebnesina street,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Fax
+98 51 3854 3031
Email
Moshirimo@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Moshiri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
ٍEbnesina Street , Emam Reza Hospital , Clinical toxicology department
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2515
Fax
+98 51 3802 2515
Email
Moshirimo@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
security of participants
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
protocol of research
When the data will become available and for how long
from now
To whom data/document is available
every researchers
Under which criteria data/document could be used
For research and treatment proposes
From where data/document is obtainable
Mohammad Moshiri
What processes are involved for a request to access data/document
send a email to correspond and introduce the proposes and team
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