With the spread of narcotics in human societies, it is important to consideration to the symptoms and conditions of addicted people and to treat these symptoms in health centers. The purpose of this study was to evaluate the effect of ondansetron on the symptoms of drug metabolism syndrome and the need for fentanyl in generalized addicts in a double-blinded study. Entry requirements include the age of the patient aged between 19-70 years and addicted to opium compounds and the exclusion criteria including the use of several opiate drugs simultaneously or prolonged the patient's operation or the seizure and maintenance of the patient with medication other than the protocol (fentanyl) to be selected. Patients in the department who have chosen the conditions for entering the study and after giving a complete and accurate description to the patient and taking pictures in a group, and to each group of these patients, different doses of andestroin include Group A: mg 4 and Group B: 8 mg and Group C: Placebo containing 2 ml of distilled water, injected intravenously 15 minutes prior to anesthesia. After the patient enters the operating room, the registered form for the signs of withdrawal is checked, and before the anesthesia process, vital signs and biochemical parameters are recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017051333940N1
Registration date:2017-07-17, 1396/04/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-17, 1396/04/26
Registrant information
Name
Hamid Reza Rahimi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5437
Email address
h_rahimi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Pharmaceutical Research Center, Kerman University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of Ondansetron on withdrawal syndrome and fentanyl requirement in opium addicted patients under general anesthesia.
Public title
Impact of Ondansetron on withdrawal syndrome and fentanyl requirement in opium addicted patients under general anesthesia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients addicted to opiates in the age range of 19-70 years and have fractures.
Exclusion criteria:addicted patients who have multi-drug use together or surgery prolongation or induction and maintenance of anesthesia with other Protocol that fentanyl not included.
Age
From 19 years old to 70 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
96
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
Pharmaceutical Research Center of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Haft Bagh Blvd.
City
Kerman
Postal code
7616911319
Approval date
2017-03-13, 1395/12/23
Ethics committee reference number
IR.KMU.REC.1395.977
Health conditions studied
1
Description of health condition studied
Addicted patients with opioid dependence
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
Withdrawal signs and pain
Timepoint
Up to 2h after ondansetron ijjection
Method of measurement
Observation
2
Description
Withdrawal signs and pain
Timepoint
Visual analogue scale
Method of measurement
Up to 2h after injection of ondansetron
Secondary outcomes
1
Description
Pain
Timepoint
Up to 2h after ondansetron injection
Method of measurement
Observation
Intervention groups
1
Description
Biography of included patients is registered and distributed in one of the study groups, and to each group of these patients, different doses of 4 mg and 8 mg of andestron are injected intravenously 15 minutes before anesthesia.
Category
Treatment - Drugs
2
Description
The control group received all the conditions for the treatment group with ondansetrone, except that they received a placebo containing 2 ml of distilled water, which is injected intravenously 15 minutes before anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar-Kerman hospital
Full name of responsible person
Morteza Hashemian
Street address
Gharani Ave.
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pharmaceutical Research Center, Faculty of Pharmacy
Full name of responsible person
Gholamreza Dehghan-Nodeh
Street address
Kerman University of Medical Sciences, 7 Bagh Blv.
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmaceutical Research Center, Faculty of Pharmacy
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
Kerman Faculty of Pharmacy
Full name of responsible person
Hamid Reza Rahimi
Position
Assistant Prof.
Other areas of specialty/work
Street address
Block L, Faculty of Pharmacy, 7 Bagh Blvd.
City
Kerman
Postal code
7616911319
Phone
+98 34 3132 5437
Fax
+98 34 3132 5003
Email
h_rahimi@kmu.ac.irhamidrrt@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Toxicology and Pharmacology, Faculty of Pharmacy
Full name of responsible person
Hamid Reza Rahimi
Position
Assistant Prof.
Other areas of specialty/work
Street address
Block L, Faculty of Pharmacy, 7 Bagh Blvd.
City
Kerman
Postal code
7616911319
Phone
+98 34 3132 5437
Fax
+98 34 3132 5003
Email
h_rahimi@kmu.ac.irhamidrrt@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Toxicology and Pharmacology, Faculty of Pharmacy
Full name of responsible person
Hamid Reza Rahimi
Position
PhD
Other areas of specialty/work
Street address
Block L, Faculty of Pharmacy, 7 Bagh Blvd.
City
Kerman
Postal code
7616911319
Phone
+98 34 3132 5437
Fax
+98 34 3132 5003
Email
h_rahimi@kmu.ac.irhamidrrt@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)