Clinical trial comparison of effect of Intravenous adminstration of Lidocaine with the combination of Mepridine and Lidocaine on reduction of Propofol induced pain on patients candidate for General Surgeries.
Objectives:This study evaluates the effect of Lidocaine and the combination of Lidovaine and Mepridine on reduction of Propofol induced pain during intravenous injection of Propofol.Design of study:The study was done as a randomized clinical trial;control with placebo,uni-central,Two trails.Setting and Conduct:Aftre entering the patients into the operating room for the General Surgeries,intravenous way is taken from the vein behind the non-dominant hand with 20 angiocatheter.premedications like Midazolam,Fentanyl etc is not be used for any patients.Torniquet for catheter insertion is closed on hand and 5cc 0.09% saline was injected to one of the groups.the 40 mg Lidocaine plus 25 mg Mepridine at dose of 5cc was injected to one of the other groups.The 40 mg lidocaine(2cc) at dose of 5cc was injected to the last group.we will wait one minute then we will open the torniquet and inject 25% of induction dose of Propofol Which is about 0.%mg/kg of bodyweight in room temprature to patient,Then we will ask the patient about pain existance and severity and then results of patients response and our observations are recorede according to pain scores and patients skin reactions like,urticaria,redness,etc Which us related to injection,our recoded till the end of recovery time.
Participants:Patients of 16-65 years addmited for General Surgery .
Exclusive criteria: The patients who recived sedative drugs 24 h before operation;Have drug allergy; Patients with Neurological Disorders or Mental Disorders: Drugs Addicts: Pregnant Women: Who requires a rapid induction of anesthesia. Sample size: Three groups of 50. Interventions time: One minute after tourniquet closure. Interventions: Lidocain adminestered intravenously in a group and Normal Salin in the control group and the combination of Lidocain and Mepridine in the third group before adminstration of Profol intravenously with it in the patient who has to be unconscious. Main outcome messures: Pain as contineouse independent variable and Drug kinds as nominal independet variable.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042315281N8
Registration date:2016-06-10, 1395/03/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-10, 1395/03/21
Registrant information
Name
Seyedebrahim Sadeghi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 4333 3278
Email address
esadeghi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Shiraz Univesity of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparison of effect of Intravenous adminstration of Lidocaine with the combination of Mepridine and Lidocaine on reduction of Propofol induced pain on patients candidate for General Surgeries.
Public title
The effect of intravenous adminstration of lidocaine and lidocaine + mepridine on reduction of propofol induced pain during intravenous injection
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion critria:Patients of 16 to 65 y/o addmited for general surgery
Exclusion criteria: Patients who recieved sedative drugs 24h before operation;Have drug allergy;With Neurological or Mental disorders;Drug Addicts;Pregnant Women;Who require of rapid induction of anesthesia and Who recieved long term steriod therapy.
Age
From 16 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
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 committe of Shiraz University of Medical Sciences(international Branch)
Street address
Shiraz University of Medical Sciences(International Branch),Accidents and Burn hospital,Sadra road 3th km.
City
Shiraz
Postal code
Approval date
2016-05-29, 1395/03/09
Ethics committee reference number
IR.SUMS.REC.1395.37
Health conditions studied
1
Description of health condition studied
Complications of anasthesia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia
Primary outcomes
1
Description
The pain measurement of intravenous injection of Propofol if previously usage intravenous injected Lidocaine
Timepoint
1 minute after injection of Lidocaine,Propofol injected and evaluate the pain
Method of measurement
Fill questionare and visual scale
2
Description
The measurement of intravenous injection of intravenous combination of Lidocaine and Mepridine
Timepoint
1 minute after injection of lidocaine and mepridine,Propofol injected and evaluate pain
Method of measurement
Fill questionare and visual scale
Secondary outcomes
1
Description
Dermal side effects
Timepoint
From injection time untill ending of recovery time
Method of measurement
Fill questionare
Intervention groups
1
Description
Control group:First group,5 cc normal saline 0.9 , 1 minute before propofol injection