Comparison intravenous anesthesia with Propofol and inhalation anesthesia with Isoflurane for pain measurement in post operative patients after inguinal herniorrhaphy
The aim of this study is comparison intravenous anesthesia with Propofol and inhalation anesthesia with Isoflurane for pain measurement in post operative patients after inguinal herniorrhaphy. This study have a clinical trial design. Researcher chosen 100 patients in elective surgery of inguinal hernia. Vital sign such as heart rate, systolic and diastolic blood pressure and oxygen saturation measured before intubation of anesthesia. Researcher used 0/5 mg / kg Midazolam and 1 μg / kg Fentanyl for all patients. Researcher injected 2 mg / kg Propofol and 0/5 kg intravenous Atracurium in both groups. Patients randomly were divided in to two groups. The first group injected 100 mg /kg/minute Propofol for the maintenance of anesthesia and second group injected 1 mg/kg/minute Isoflurane for the maintenance of anesthesia. Intubation time and recovery time is recorded. Pain was measured in the recovery room (zero time) and after 6 hours (every 2 hours) based on the VAS scale. Patient’s vital signs measured at zero time. Nausea and vomiting and shivering of patients were recorded during this period. 75 mg Diclofenac was injected for patient in the postoperative room if VAS scale was more than 3 during 6 hours after surgery .Dose of Diclofenac was recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112925277N1
Registration date:2015-12-24, 1394/10/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-24, 1394/10/03
Registrant information
Name
Tahereh Mohaqeq
Name of organization / entity
Arak University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 930 315 5687
Email address
t.mohaqeq@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences and Health Services
Expected recruitment start date
2015-11-30, 1394/09/09
Expected recruitment end date
2017-02-27, 1395/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison intravenous anesthesia with Propofol and inhalation anesthesia with Isoflurane for pain measurement in post operative patients after inguinal herniorrhaphy
Public title
Comparison intravenous anesthesia with Propofol and inhalation anesthesia with Isoflurane for pain measurement in post operative patients after inguinal herniorrhaphy
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria: history of allergic reaction to the drug used in this study, pregnancy, drug addiction, and pain relief medications 24 hours before surgery, persistent hypertension, cardiovascular disease, renal failure
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences and Health Services
Street address
Research Center, Educational complex Payambar Azam, Basij square, Sardasht
City
Arak
Postal code
38481-7-6941
Approval date
2015-07-27, 1394/05/05
Ethics committee reference number
IR.ARAKMU.REC.1394.110
Health conditions studied
1
Description of health condition studied
Inguinal herniorrhaphy
ICD-10 code
K40.3
ICD-10 code description
Unilateral or unspecified inguinal hernia, with obstruction, without gangrene
Primary outcomes
1
Description
Pain
Timepoint
recovery room ( zero time ) and after 6 hours (every 2 hours)
Method of measurement
Visual Analog Scale
2
Description
Temprature
Timepoint
Before and after surgery
Method of measurement
Thermometer
3
Description
Blood pressure
Timepoint
Before and after surgery
Method of measurement
Barometer
4
Description
Heart rate
Timepoint
Before and after surgery
Method of measurement
Rate in minute
5
Description
Respiratory
Timepoint
Before and after surgery
Method of measurement
Rate in minute
6
Description
Intubation time
Timepoint
After surgery
Method of measurement
Minute
7
Description
Recovery time
Timepoint
After surgery
Method of measurement
Minute
Secondary outcomes
1
Description
Diclofenac
Timepoint
After surgery
Method of measurement
Drug dose
Intervention groups
1
Description
first group injected 100 mg /kg/minute propofol for the maintenance of anesthesia
Category
Treatment - Drugs
2
Description
second group injected 1 mg/kg/minute isoflurane for the maintenance of anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Tahereh Mohaqeq
Street address
Valiasr Hospital ,Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Arak University of Medical Sciences and Health Services
Full name of responsible person
Dr Bijan Yazdi
Street address
Research Center, Educational complex Payambar Azam, Basij square, Sardasht
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Arak University of Medical Sciences and Health Services
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
Arak University of Medical Sciences and Health Services
Full name of responsible person
Tahereh Mohaqeq
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
Research Center, Educational complex Payambar Azam, Basij square, Sardasht
City
Arak
Postal code
38481-76941
Phone
+98 86 3417 3504
Fax
Email
t.mohaqeq@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences and Health Services
Full name of responsible person
Dr Bijan Yazdi
Position
Assisstant Professor, Fculty of Anesthesia
Other areas of specialty/work
Street address
Valiasr Hospital
City
Arak
Postal code
38481-7-6941
Phone
+98 86 2222 0034
Fax
Email
t.mohaqeq@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences and Health Services
Full name of responsible person
Tahereh Mohaqeq
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
Research Center, Educational complex Payambar Azam, Basij square, Sardasht
City
Arak
Postal code
38481-7-6941
Phone
+98 86 3417 3504
Fax
Email
t.mohaqeq@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)