Determination the Effect of interathecal Petidine Injections in Comparison with intrathecal Bupivacaine on Hemodynamic Stability in Hip Surgery.
Design
A triple blinded randomized clinical trial with parallel groups. 60 patients participated in the study and they were divided into two groups (30 patients in each group).
Settings and conduct
This study will be carried out in the operating room of 5th Azar hospital in Gorgan city.Anesthesia and recording of vital signs will be done by the resident of anesthesiology who is unaware of the drug type being injected
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with hip or femoral fractures. Exclusion criteria: Allergy to Local Anesthetics and Pethidine; Coagulation Disorders; Patients refusal inability to maintain position during needle puncture; localized sepsis of the puncture site; High Intra Cranial Pressure.
Intervention groups
All patients admitted to the hospital with a hip and femoral fracture and are candidates for surgery, are going to be examined to enter the study. Patients are going to be categorized into two intervention groups. In intervention group1 patients are going to be anesthetized by intrathechal injection of 1 mg/kg Pethidine(Aburaihan pharmaceutical Co.), which is diluted by normal saline until it reaches 2 mL volume.
In intervention group 2 patients are going to be anesthetized by intrathechal injection of 2 mL room temperatured Bupivacaine 0.5%(equall to 10 mg of bupivacaine) produced by Mylan Co.
Main outcome variables
Heart rate per minute, mean arterial pressure, systolic blood pressure, diastolic blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180603039966N1
Registration date:2018-08-31, 1397/06/09
Registration timing:registered_while_recruiting
Last update:2018-08-31, 1397/06/09
Update count:0
Registration date
2018-08-31, 1397/06/09
Registrant information
Name
Sina Hasannasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3235 2508
Email address
sina.hasannasab@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of interathecal injection of pethidine versus bupivacaine on hemodynamics in hip surgery.
Public title
Comparison the effect of interathecal injection of pethidine versus bupivacaine on hemodynamics
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with hip or femoral fractures
Exclusion criteria:
Allergy to Local Anesthetics and Pethidine
Coagulation Disorders
Patients refusal
inability to maintain position during needle puncture
localized sepsis of the puncture site
High Intra Cranial Pressure
Age
From 20 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is going to be performed using sequentially numbered, sealed, non-opaque envelopes.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Considering the design of the research and the method of randomization and implementation of latent structure, just the supervisor is aware of the syringe contents which is labeled with A or B. In this research, not only the patients, but also the observer(Resident of anesthesiology who perform the block and record the vital signs) and the statistical analyst are also unaware of the syringe contents and which letter(A or B) belong to which intervention groups. So this research is a triple blinded which is performed via sequentially numbered, sealed, non-opaque envelopes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Shast Kola road, Hirkan Blvd
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2018-05-20, 1397/02/30
Ethics committee reference number
IR.GOUMS.REC.1397.017
Health conditions studied
1
Description of health condition studied
Fractures of the hip and femor
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Heart Rate per minute
Timepoint
Heart rate per minute, will be recorded on minutes 0, 3, 6, 9, 12, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 75, 90 and every 30 minute after that.
Method of measurement
vital signs will be measured by Saadat (Alborz B9) patient's monitoring device
2
Description
Mean Arterial Pressure(MAP)
Timepoint
Mean Arterial Pressure(MAP), will be recorded on minutes 0, 3, 6, 9, 12, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 75, 90 and every 30 minute after that.
Method of measurement
vital signs will be measured by Saadat (Alborz B9) patient's monitoring device
3
Description
Systolic Blood Pressure
Timepoint
Systolic Blood Pressure, will be recorded on minutes 0, 3, 6, 9, 12, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 75, 90 and every 30 minute after that.
Method of measurement
vital signs will be measured by Saadat (Alborz B9) patient's monitoring device
4
Description
Diastolic Blood Pressure
Timepoint
Diastolic Blood Pressure, will be recorded on minutes 0, 3, 6, 9, 12, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 75, 90 and every 30 minute after that.
Method of measurement
vital signs will be measured by Saadat(Alborz B9) patient's monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: patients with hip or femor fractures, who are candidates for surgery, are going to be anesthetized by intrathechal injection of 1 mg/kg Pethidine(Aburaihan pharmaceutical Co.), which is diluted by normal saline until it reaches 2 mL volume.
Category
Treatment - Drugs
2
Description
Intervention group 2: patients with hip or femor fractures, who are candidates for surgery, are going to be anesthetized by intrathechal injection of 2 mL room temperatured Bupivacaine 0.5%(equall to 10 mg of bupivacaine) produced by Mylan Co.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
5 Azar hospital
Full name of responsible person
Babak Mojaver Aghili
Street address
5 Azar street
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3222 0561
Email
Dr.mojaveraghili@goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Babak Mojaver Aghili
Street address
Shast-kola Road, Hirkan blvd
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 2651
Email
Gsm@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Babak Mojaver Aghili
Position
assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
5 Azar street
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3222 0561
Email
Dr.mojaveraghili@goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Seyyed Babak Mojaver Aghili
Position
Assistant Proffessor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
5 Azar street
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3222 0561
Email
Dr.mojaveraghili@goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Sina Hasannsab
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
5 Azar street
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3222 0561
Email
sina.hasannasab@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available