Efficacy of premedication with dextromethorphan and gabapentin alone or in combination for postoperative pain management in ACL and PCL knee arthroscopy with general anesthesia
efficacy of premedication with dextromethorphan and gabapentin alone or in combination for postoperative pain management in ACL and PCL knee arthroscopy with general anesthesia
Design
clinical trial with control group with parallel groups, blind, randomized
Settings and conduct
after designating operational teams and selecting patients with conditions , medications are dissolved and the drug is randomed to patients one hour before surgery and after anesthesia and at the end of the operation, the patient's pain and pain relief were collected ( with NRS and Ramsy )
Participants/Inclusion and exclusion criteria
all patient for knee arthroscopy surgery under general anesthesia 18 to 60 years old ; ASA 1-2 class
Intervention groups
Intervention group: all patients undergoing arthroscopic knee arthroscopy with general anesthesia aged 18 to 60 years with ASA1-2 anesthetics class ; One hour before anesthesia, received a medication randomly
Control group: negative
Main outcome variables
age ; gender ; pain ; drug
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141127020112N9
Registration date:2019-06-16, 1398/03/26
Registration timing:retrospective
Last update:2019-06-16, 1398/03/26
Update count:0
Registration date
2019-06-16, 1398/03/26
Registrant information
Name
Pooya Derakhshan
Name of organization / entity
Birjand Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3234 1410
Email address
pooya_derakhshan@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-01, 1396/06/10
Expected recruitment end date
2018-09-01, 1397/06/10
Actual recruitment start date
2017-09-01, 1396/06/10
Actual recruitment end date
2018-10-02, 1397/07/10
Trial completion date
2018-12-01, 1397/09/10
Scientific title
Efficacy of premedication with dextromethorphan and gabapentin alone or in combination for postoperative pain management in ACL and PCL knee arthroscopy with general anesthesia
Public title
Efficacy of premedication with dextromethorphan and gabapentin alone or in combination for postoperative pain management in ligament of knee surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patient for knee arthroscopy surgery under general anesthesia
18 to 60 years old
ASA 1-2 class
Exclusion criteria:
history of sensitivity to drugs that used in study
Opium addiction
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
114
Actual sample size reached:
114
Randomization (investigator's opinion)
Randomized
Randomization description
use the random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
With the cooperation of the pharmaceutical company the drug Gabapentin and Dextromethorphan and the combination of these two were dissolved in the same volume and shape and color and based on the numbers the patients were given an oral dose one hour before surgery. The patients and the donor did not know which group were.
Placebo
Not 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
Street address
Rasoul Akram Hospital ; Mansouri St ; Satarkhan St
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2016-12-09, 1395/09/19
Ethics committee reference number
IR.IUMS.REC 1395.8921215111
Health conditions studied
1
Description of health condition studied
Efficacy of premedication with dextromethorphan and gabapentin alone or in combination for postoperative pain management in ACL and PCL knee arthroscopy with general anesthesia
ICD-10 code
S83.5
ICD-10 code description
Sprain of cruciate ligament of knee
Primary outcomes
1
Description
pain rate
Timepoint
NRS scale at 0, 2, 4, 8, 12, and 24 hours
Method of measurement
Numeric Rating Scale ; Ramsay
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 : 100 mg oral Gabapentine, 1hour before surgery
Category
Treatment - Other
2
Description
Intervention group 2: 1mg/kg oral Dextromethorphan 1hour before surgery
Category
Treatment - Other
3
Description
Intervention group 3: 100 mg oral Gabapentine and 1mg/kg oral Dextromethorphan compound soluble in water, 1hour before surgery
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Pooya Derakhshan
Street address
Rasoul Akram Hospital ; Mansouri St ; Satarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
PR@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakooti
Street address
Iran University of Medical Sciences., next to Milad Tower., Hemat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8163 3685
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
1
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
Iran University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences., next to Milad Tower., Hemat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8163 3685
Email
Pooya_derakhshan@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences., next to Milad Tower., Hemat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8163 3685
Email
pooya_derakhshan@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences., next to Milad Tower., Hemat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8163 3685
Email
pooya_derakhshan@bums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
we have not yet set a conclusion
When the data will become available and for how long
we have not yet set a conclusion
To whom data/document is available
we have not yet set a conclusion
Under which criteria data/document could be used
we have not yet set a conclusion
From where data/document is obtainable
we have not yet set a conclusion
What processes are involved for a request to access data/document