Comparison of Propofol alone and Propofol with Muscle relaxant on hemodynamic and laryngeal mask airway insertion condition during induction of anesthesia.
Design
A double-blind clinical trial, with Parallel and randomized groups of 70 patients ranging in age from 18 to 65 years with ASA I and II who is candidates for elective surgery. Randomization will be done based on Block Randomization method using Allocation Random software.
Settings and conduct
This double blind clinical trial study will be conducted at Shahid Mohammadi hospital in Bandar Abbas. LMA with appropriate size will be improvised in sniffing position and the data will be recorded by an anesthesiologist who is not aware of the study
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients between 18-65 years of age, physical condition (ASA I and II), are candidates for elective surgery.
Non-inclusion criteria: drug allergy, emergency patients, patients with full stomach, patients with a history of upper respiratory tract infection, high intra cranial pressure (ICP), asthma, COPD, obesity (BMI<40)
Intervention groups
Intervention group 1:Intravenous injection of 2.5 mg/kg propofol with saline(Dose equal to cisatracurium).
Intervention group 2: Intravenous injection of 2.5 mg/kg propofol with 0.2 mg/kg cisatracurium.
Comparison of Propofol alone and Propofol with Muscle relaxant on hemodynamic and LMA insertion condition during induction of anesthesia
Public title
Use of muscle relaxants in laryngeal mask airway insertion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient age between 18-65 years
Physical Condition (ASA I and II)
Candidate for elective surgery
Exclusion criteria:
Drug sensitivity
Emergency patients
Patients with full stomach
Patients with a history of upper respiratory tract infection
Asthma
COPD
Obesity BMI <40
High ICP
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation was done using block randomization method and Random Allocation software and 70 patients were divided into two groups of 35 patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are unaware of being in which group. LMA insertion and data recording was done by an experienced anesthesiologist who was not aware of the study process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bandar abbas University of Medical Sciences
Street address
Republic Street, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Approval date
2017-01-11, 1395/10/22
Ethics committee reference number
HUMS.REC.1394.104
Health conditions studied
1
Description of health condition studied
Finding an easy and safe way to operate LMA with minimal complications
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hemodynamic changes after injection
Timepoint
Before induction of anesthesia, before, during, and 1, 3 and 5 minutes after LMA insertion
Method of measurement
Hemodynamic changes registration form
2
Description
The laryngeal mask airway insertion status after injection
Timepoint
Evaluation of LMA insertion variable changes before, during, and 1, 3 and 5 minutes after LMA insertion.
Method of measurement
Ease of masking table, table parameters during insertion, removal of the LMA and duration of surgery.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intravenous propofol 2.5 mg/kg(PROPOFOL1 mg/10 ml, B Braun Co, in Germany) and 0.2 mg/kg cisatracurium (muscle relaxant)(Cisatrecurium 10mg/5ml Rosamed-Iran) were injected. After 4 minutes of ventilation with pure oxygen, the LMA of appropriate size was standardized by an anesthesiologist who was unaware of the study and the information was recorded in a form.
Category
Treatment - Drugs
2
Description
Control group: 2.5 mg/kg propofol (PROPOFOL1 mg/10 ml, B Braun Co, in Germany) and normal saline were injected with equal volume of relaxant. After 4 minutes of ventilation with pure oxygen, the LMA of appropriate size was standardized by an anesthesiologist who was unaware of the study and the information was recorded in a form.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Hashem Jarineshin
Street address
Shahid Mohammadi hospital, Jomhoori street
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 7001
Email
motahareh.khojastehrad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Street address
Shahid Mohammadi hospital, Jomhoori street
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 7001
Email
motahareh.khojastehrad@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Mohammadi hospital, Jomhoori street
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 7001
Email
hjarineshin@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Mohammadi hospital, Jomhoori street
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 7001
Email
hjarineshin@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Motahareh khojastehrad
Position
Anesthesiologist
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Shahid Mohammadi hospital, Jomhoori street
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 7002
Email
motahareh.khojastehrad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Title and more details about the data/document
Only the results section can be shared.
When the data will become available and for how long
Start access period 3 months after publishing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Announced as a reference.
From where data/document is obtainable
motahareh.khojastehrad@gmail.com
What processes are involved for a request to access data/document