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Study the effect of memantine on acute postoperative pain after elective hysterectomy .

Protocol summary

Summary
Summary: Objective: To determine the effect of memantine on the control of acute postoperative pain after elective hysterectomy Design Study: Randomized, double blind, control with medication, Parallel, stage two trials Method of study: A. Population studied: Patients referring to Imam Ali Hospital in the year 96-97 undergoing hysterectomy. o Main criteria for entering the study: patient satisfaction, ages 20 to 70, selective hysterectomy surgery. o Main exclusion criteria for the study of liver-renal or cardiac diseases and psychiatric illness that may disturb the patient's assessment, drug addiction or any other psychoactive substance, patient's death, and patient's lack of cooperation. Sample size In this study, we survey 30 patients in each group, of which 60 will be included in the study. B) Intervention or intervention: One group received 20 mg of oral memantine and the other group received placebo. C. Time of intervention: one hour before the operation D-Primary outcome or outcome of the study: patient's pain score (VAS), sedation score, side effects such as nausea and vomiting, and total dose of narcotic in addition to paracetamol at 0 (recovery), 6, 12, 24, 36 and 48

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017070434888N1
Registration date: 2017-11-01, 1396/08/10
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-11-01, 1396/08/10
Registrant information
Name
Saeed Keshtgar
Name of organization / entity
university of medical sciences of zahedan
Country
Iran (Islamic Republic of)
Phone
+98 54 3328 6765
Email address
keshtgarsaeed@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences Research Committee
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of memantine on acute postoperative pain after elective hysterectomy .
Public title
Study the effect of memantine on acute pain
Purpose
Supportive
Inclusion/Exclusion criteria
Main criteria for entering the study: patient satisfaction, ages 20 to 70, selective hysterectomy surgery. Main exclusion criteria for the study of liver-renal or cardiac diseases and psychiatric illness that may disturb the patient's assessment, drug addiction or any other psychoactive substance, patient's death, and patient's lack of cooperation
Age
From 20 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
The random blocks are divided into two groups: memantine (A) and placebo (B) This study is two-sided, and only the doctor responsible for distributing the drug knows its name, and the patient and the other physician who record the pain score and calibrate score after the operation are unaware of the type of medication used to reduce the associated bias or bouts. Intervention and evaluation of consequences are used in this way, and this way it is possible to measure objectively the outcome.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan Square Dr. Hesabi University of Medical Sciences campus
City
Zahedan
Postal code
Approval date
2017-04-16, 1396/01/27
Ethics committee reference number
IR.ZAUMS.REC.1396. 9

Health conditions studied

1

Description of health condition studied
pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain

2

Description of health condition studied
Hysterectomy
ICD-10 code
Z90.7
ICD-10 code description
Acquired absence of genital organ(s)

Primary outcomes

1

Description
Pain score
Timepoint
At recovery and hours 6, 12, 24, 36 and 48 after surgery
Method of measurement
Score measured by VAS criteria

Secondary outcomes

1

Description
Relaxation
Timepoint
At recovery and hours 6, 12, 24, 36 and 48 after surgery
Method of measurement
Relaxation based on Ramsey's relaxation score

2

Description
Drug use Required Patient
Timepoint
Within 48 hours after surgery
Method of measurement
Drug use included in patient file

3

Description
Complications (nausea and vomiting)
Timepoint
Within 48 hours after surgery
Method of measurement
Ask the patient for the presence or absence of nausea and vomiting

Intervention groups

1

Description
Memantine, 20 mg oral tablet, one hour before surgery
Category
Treatment - Drugs

2

Description
placebo
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Aliebnabitaleb hospital
Full name of responsible person
asadolah shakeri
Street address
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of university of medical sciences of zahedan
Full name of responsible person
dr hushang rafighdust
Street address
doctor hesabi square, zahedan
City
zahedan
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 university of medical sciences of zahedan
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
university of medical sciences of zahedan
Full name of responsible person
Dr asadolah shakeri
Position
assistant professor
Other areas of specialty/work
Street address
doctor hesabi square, zahedan
City
zahedan
Postal code
Phone
+98 54 3329 5571
Fax
Email
keshtgarsaeed341@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
university of medical sciences of zahedan
Full name of responsible person
Dr asadolah shakeri
Position
Intravenous fellowship of pain
Other areas of specialty/work
Street address
doctor hesabi square, zahedan
City
zahedan
Postal code
Phone
+98 54 3329 5571
Fax
Email
keshtgarsaeed341@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
university of medical sciences of zahedan
Full name of responsible person
Dr asadolah shakeri
Position
assistant professor
Other areas of specialty/work
Street address
doctor hesabi square, zahedan
City
zahedan
Postal code
Phone
+98 54 3329 5571
Fax
Email
keshtgarsaeed341@yahoo.cob
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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