The aim of this double blind clinical trial is to compare the effect of standard lidocaine versus a mixture of standard lidocaine and pethidine on hemodynamics of patients who are candidates for open prostatectomy. All patients will be catheterized with gauge 18 needles and will receive 500 cc of normal saline before the procedure. Patient will be randomly allocated into two groups of intervention and control. Sample sizes in the two groups are the same and 39 patient. Monitoring in the two groups are the same and routine (pulse oximetery, NIBPmonitoring, core temperature monitoring, ECG monitoring, input and out put, need for sympatomimetic, and need for pain control drugs). The amount of blood loss will be estimated by anesthesiologist and the surgeon in two groups through consensus. In control group all patient will receive lidocaine 5% up to 2 millilitre and in case group all patient will receive lidocaine %5 and 0.5 mg/kg pethidine up to 2 millilitre .Drug will be injected intratechally in all patient by a size 24 needle via space L4-L5. After injection of drug all patients will be put in horizontal position and the anesthesia level in all participants will be T8.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903061936N2
Registration date:2010-10-15, 1389/07/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-10-15, 1389/07/23
Registrant information
Name
Abdolreza Najafi Anaraki
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1354 0088
Email address
najafianaraki@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr university of medical science
Expected recruitment start date
2009-12-08, 1388/09/17
Expected recruitment end date
2010-11-07, 1389/08/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparitive Study Between the effect of Intra techal Petidine and Lidocaine versus Standard Lidocaine on Hemodynamics in Open Prostatic Surgery
Public title
Comparitive Study Between the effect of Intra techal Petidine and Lidocaine versus Standard Lidocaine on Hemodynamics in Open Prostatic Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
All patient who are candidates for open prostatectomy are eligible to participate in the study. Exclusion criteria: age above 75 and below 45, history of sensitivity to opioid, unwilling to participate and coagulopathy
Age
From 45 years old to 75 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
other
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee ofBushehr university of medical science
Street address
Bushehr university of medical science
City
Bushehr
Postal code
Approval date
2009-04-10, 1388/01/21
Ethics committee reference number
4314/3/18/20/دپ
Health conditions studied
1
Description of health condition studied
To study effect of intratechal standard lidocaine and mixture of lidocaine and pethidine on hemodynamic of patient in open prostatectomy
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Hemodynamic change (BP change)
Timepoint
pre induction and in minute 1,2,3,5,10,15,20,25,30,45,60,90,120
Method of measurement
NIBP monitoring
Secondary outcomes
1
Description
Temperature change
Timepoint
60 minute
Method of measurement
Temperature Monitoring
2
Description
Post operative nausea and vomiting
Timepoint
120 minute
Method of measurement
observation
3
Description
Post operative pain
Timepoint
120 minute
Method of measurement
Analogous pain score
4
Description
Intra operative blood loss
Timepoint
120 minute
Method of measurement
observation
Intervention groups
1
Description
In control group all patient received lidocaine 5% intratechally (2 cc)and needle entrance is space L4-L5.Other intervention in two group is same.
Category
Prevention
2
Description
In case group all patient received lidocaine 5% pulse pethidine 0/5 mg/kg up to 2 cc intratechally and needle entrance is space L4-L5.Other intervention in two group is same.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fateme Zahra hospital
Full name of responsible person
Najafi Anaraki
Street address
Bushehr, Fateme Zahra hospital
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research committee of medical science of bushehr university
Full name of responsible person
Dr Asadi
Street address
Bushehr, Faculty of Medicine
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research committee of medical science of bushehr university
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr university of medical science
Full name of responsible person
Dr Najafi Anaraki
Position
Assistant professor
Other areas of specialty/work
Street address
Bushehr university of medical science
City
Bushehr
Postal code
Phone
+98 77 1354 0088
Fax
Email
arna566@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr university of medical science
Full name of responsible person
Dr Najafi Anarki
Position
Assistant professor
Other areas of specialty/work
Street address
Bushehr university of medical science
City
Bushehr
Postal code
Phone
+98 77 1354 0088
Fax
Email
arna566@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)