Comparison of the effect of adding Neostigmine to Ropivacaine and sufentanilto Ropivacaine in spinal anesthesia for herniorrhaphy surgery
Design
This study is clinical trial and double blind.105 patients candidate herniorrhaphy surgery in Valiasr hospital will inter this study.We will divide patients in 3 groups by simple randomization.Groups are parallel.
Settings and conduct
105 patients candidate herniorrhaphy surgery in valiasr hospital.This study is double blind. Outcome assessor and analyzer not aware from grouping.Codes of group are available to analyzer and outcome assessor.We record blood pressure,heart rate , oxygen saturation, pain and duration motor and sensory block in each group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:18 to 60 years, patients candidate inguinal hernia surgery, lack of cardiovascular problems, absence of coagulation disorders ,lack of peripheral and central neuropathy, no history of allergy to Neostigmine and Ropivacaine and Sufentanil, non-localized infection in the spinal cord
Exclusion criteria:Patient dissatisfaction ,failure to perform spinal anesthesia
Intervention groups
First group: We inject 3 milliliter of Ropivacaine(15 milligram) plus 50 micro gram Neostigmine (Caspian.Co.Rasht)(1 milliliter) in form of intrathecal.
Second group: We inject 3 milliliter of Ropivacaine(15 milligram) plus 5 micro gram Sufentanil (Aboreihan.Co)(1 milliliter) in form of intrathecal.
Third group: We inject 3 milliliter of Ropivacaine(15 milligram) plus 1 milliliter distilled water (Daropakhsh.Co)(1 milliliter) in form of intrathecal.
Main outcome variables
blood pressure- heart rate - oxygen saturation- pain - duration motor and sensory block - drug consumption
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N107
Registration date:2019-04-23, 1398/02/03
Registration timing:registered_while_recruiting
Last update:2019-04-23, 1398/02/03
Update count:0
Registration date
2019-04-23, 1398/02/03
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-01, 1397/12/10
Expected recruitment end date
2020-02-29, 1398/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of adding Neostigmine to Ropivacaine and sufentanilto Ropivacaine in spinal anesthesia for herniorrhaphy surgery
Public title
Comparison of the effect of adding Neostigmine to Ropivacaine and sufentanilto Ropivacaine in spinal anesthesia for herniorrhaphy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 60 years
Patients candidate inguinal hernia surgery
Lack of cardiovascular problems
Absence of coagulation disorders
Lack of peripheral and central neuropathy
No history of allergy to Neostigmine and Ropivacaine and Sufentanil
Non-localized infection in the spinal cord
Exclusion criteria:
Patient dissatisfaction
Failure to perform spinal anesthesia
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random number table in division of groups in two groups A and B and C
Randomization method: Simple randomization.
Random unit: Individual.
How to build sequences: First, we set the framework for our statistical society. We started from a table point in a row or column. Given the type of code in the row, we chose the same number of digits. After that, the numbers control the path. We noticed smaller numbers of the statistical community. We have to continue this work so that the number of samples is completed.Even numbers were used for intervention group and odd numbers were used for the control group.
Allocation concealment:Numbered drug containers
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B and C are available to analyzer and outcome assessor.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2019-02-24, 1397/12/05
Ethics committee reference number
IR.ARAKMU.REC.1397.356
Health conditions studied
1
Description of health condition studied
Spinal anesthesia
ICD-10 code
X64
ICD-10 code description
Intentional self-poisoning by and exposure to other and unspecified drugs, medicaments and biological substances
Primary outcomes
1
Description
Mean arterial blood pressure
Timepoint
Every 15 minutes during surgery and recovery time and up to 2 hours after surgery
Method of measurement
Barometer
2
Description
Heart rate
Timepoint
Every 15 minutes during surgery and recovery time and up to 2 hours after surgery
Method of measurement
Count
3
Description
Percent of oxygen saturation
Timepoint
Every 15 minutes during surgery and recovery time and up to 2 hours after surgery
Method of measurement
Pulse oximetry
4
Description
Duration of motor block
Timepoint
Every 5 minute
Method of measurement
Minute
5
Description
Duration of Sensory block
Timepoint
Every 1minute
Method of measurement
Minute
6
Description
Pain
Timepoint
Recovery and 2, 4, 8, 12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale Questionnaire
7
Description
mean of narcotic
Timepoint
24 hour after surgery
Method of measurement
Milligram
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We inject 3 milliliter of Ropivacaine(15 milligram) plus 50 micro gram Neostigmine (Caspian.Co.Rasht)(1 milliliter) in form of intrathecal.
Category
Treatment - Drugs
2
Description
Intervention group: We inject 3 milliliter of Ropivacaine(15 milligram) plus 5 micro gram Sufentanil (Aboreihan.Co)(1 milliliter) in form of intrathecal.
Category
Treatment - Drugs
3
Description
Control group: We inject 3 milliliter of Ropivacaine(15 milligram) plus 1 milliliter distilled water (Daropakhsh.Co)(1 milliliter) in form of intrathecal.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Hesamedin Modir
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
modir.he@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
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
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamedin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street