Protocol summary

Summary
Objectives: Acute pain control after surgery is a crucial fact in health management. Memantine is a N-Methyl-D-aspartate (NMDA) antagonist which is a leading drug for Alzheimer's disease treatment. Design: In this double blind randomized clinical trial, 60 patients candidate for dacryocystorhinostomy are assigned. Choosing envelope number 1 or 2, patients are randomly allocated to memantine or placebo group. Patients, anesthesiologist and the statistician are blinded to the assignments. This clinical trial is in phase 2 / phase 3. Setting and conduct: General anesthesia will be carried out with fentanyl 2 micro gram per kilogram, midazolam 0.12 milligram per kilogram, sodium thiopental 5 milligram per kilogram and atracurium 0.5 milligram per kilogram. After tracheal intubation anesthesia will be maintained with propofol 100 micro grams per kilogram per minute Major inclusion and exclusion criteria: Participants with written consent form and without any serious cardiovascular, respiratory, renal, liver, cerebral disease and addiction are included in the study. Patients whom do not meet all the above criteria are excluded. Intervention: Oral memantin 40 mg (exir darou, Iran) or placebo (flour tablet) will be administered to the patients in each group at entrance to the operation room and before anesthesia. Main outcome measurements: Visual analogue scale and ramsey scale will be used immediately, 1, 2 and 6 hours after surgery, for the measurement of pain and sedation score, respectively. Data will be recorded and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016011810599N5
Registration date: 2017-01-05, 1395/10/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-05, 1395/10/16
Registrant information
Name
Poupak Rahimzadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
p-rahimzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran university of medical sciences, Faculty of research
Expected recruitment start date
2016-07-30, 1395/05/09
Expected recruitment end date
2016-12-30, 1395/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A double blinded clinical trial for evaluation of oral memantine and placebo in acute postoperative pain in patients undergoing dacryocystorhinostomy
Public title
Effects of memantine in Dacryocystorhinostomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with written informed consent; without seriuos cardiovascular, respiratory, renal, liver, cerebral disease and addiction; 18-65 years age. Exclusion criteria: not meeting all the inclusion criteria
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
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
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran university of medical sciences, Hemmat Expressway, Tehran
Street address
Hemmat Expressway, Tehran
City
Tehran
Postal code
Approval date
2016-06-01, 1395/03/12
Ethics committee reference number
27356

Health conditions studied

1

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

Primary outcomes

1

Description
pain score
Timepoint
at the end of the surgery (0) and 1, 2 & 6 hours after surgery
Method of measurement
visual analogue scale and ramsey scale

Secondary outcomes

1

Description
Pain killer number
Timepoint
after operation (0) and 1, 2 & 6 hours after surgery
Method of measurement
number of pain killer used and recorded in questionnaire

Intervention groups

1

Description
intervention group: Patients will receive 40 milligrams of oral memantin (Exir darou,Iran) at the entrance to the operating room.Then the patients will receive induction for anesthesia.
Category
Treatment - Drugs

2

Description
Control group: Patients will receive flour tablets at the entrance to the operating room. Then the patients will receive induction for anesthesia.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Eye operating room, Hazrat Rasul Medical Complex, Sattar khan Ave. , Tehran
Full name of responsible person
Dr Poupak Rahimzadeh
Street address
Sattar khan ave. , Hazrat Rasul Medical complex, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research­ Iran University of Medical Sciences, Hemmat expressway, Tehran
Full name of responsible person
Dr Mohammad Musavi
Street address
Hemmat expressway, Tehran
City
Tehran
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 Iran University of Medical Sciences, Hemmat expressway, Tehran
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
Iran University of Medical Sciences, Hemat expressway, Tehran
Full name of responsible person
Dr Hamidreza Faiz
Position
Associate professor
Other areas of specialty/work
Street address
Hazrat Rasul Medical complex, Sattar khan Ave. , Tehran
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
hrfaiz@hotmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences, Hemmat expressway, Tehran
Full name of responsible person
Dr Poupak Rahimzadeh
Position
Associate professor
Other areas of specialty/work
Street address
Hazrat Rasul Medical complex, Sattar khan Ave. , Tehran
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
p-rahimzadeh@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences, Hemmat Expressway, Tehran
Full name of responsible person
Dr Poupak Rahimzadeh
Position
Associate professor
Other areas of specialty/work
Street address
Hazrat Rasul Medical complex, Sattar khan Ave. , Tehran
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
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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