Comparing the effects of Propofol-Ketamine with Propofol-Remifentanile on blood pressure and heart rate changes in patients candidate for Fibro optic Bronchoscopy
The comparison effect of prescribing Propofol- Remifentanil with Propofol-Ketamine on blood pressure and heart rate changes in patients undergoing fibropeptic bronchoscopy
Design
In this double blind randomized clinical trial study with paralel groups, 68 patients candidate for Fibrooptic Bronchoscopy are selected and randomly allocated in to two groups of 38 subjects by Random Alocation software. The first group receive the combination of Ketamine + Remifentanil and the second group receive Propofol + Remifentanil and the incidence of Hemodynamic disorders and other complications during the procedure and in recovery will be determined and will be compared between two groups.
Settings and conduct
This double-blind clinical trial study will done in 2019 at Alzahra Hospital in Isfahan on patients candidates for fibro-optics bronchoscopy . In this study, patients and researchers are not aware of the type of drug they receive.
Participants/Inclusion and exclusion criteria
Inclusion criteria: candidate for Bronchoscopy; age range between 18-60 years; Patient agrees to participate. Non-inclusion criteria: History of alcohol and drug addiction; History of chronic illness such as mental disorders; History of seizure .
Intervention groups
Intervention group 1: Propofol-Remifentanil. Receiving 1μg / kg Remifentanil + 10 mg of propofol and 50 ug/kg per minute as the maintenance dose. Intervention group 2: Propofol-Ketamine, Receiving 0.5 mg / kg of ketamine+ 10 mg of propofol and 50 ug/kg per minute as the maintenance dose.
Main outcome variables
blood pressure; heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N33
Registration date:2019-08-17, 1398/05/26
Registration timing:prospective
Last update:2019-08-17, 1398/05/26
Update count:0
Registration date
2019-08-17, 1398/05/26
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-22, 1398/06/31
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of Propofol-Ketamine with Propofol-Remifentanile on blood pressure and heart rate changes in patients candidate for Fibro optic Bronchoscopy
Public title
Comparison effect of three different drug combinations on Blood Pressure and Heart rate of patients under Bronchoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ASA (American Society of Anesthesiologists) < 4
patients candidate for bronchoscopy
Exclusion criteria:
body mass index>35
history of alcohol consumption or addiction
history of severe allergy
history of psychologic diseases
history of epilepsy of seizure
patient with unstable status
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 86 patients candidate for bronchoscopy were selected and divided into two groups of 38 subjects by Random Allocation software .
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind clinical trial. Patients and the investigator are not aware about the type of drug injected. The medications are prepared by one of the operating room personnel in the same and encoded syringes and will be given to researcher for injection.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Department of anesthesiology, Alzahra hospital, Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-01-31, 1395/11/12
Ethics committee reference number
IR.MUI.REC.1395.3.695
Health conditions studied
1
Description of health condition studied
Bronchoscopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Blood Pressure
Timepoint
every 5 minutes during procedure and recovery
Method of measurement
palsoxymetery
Secondary outcomes
1
Description
heart rate
Timepoint
every 5 minutes during procedure and recovery
Method of measurement
palsoxymetery
Intervention groups
1
Description
Intervention group: receive 1ug/kg injectable Remifentanil (Razavi Pharmacational institute) with 0.5 mg/kg ketamin(made by Bremore Company) through intravenous infusion.
Category
Prevention
2
Description
Control group: receive combination of remifentanyl + propoful
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Zeynab Mohebbi
Street address
Department of Anesthesiology, Alzahra hospital, Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
Email
zeynabmohebbi7@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Research faculty, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3070
Email
haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
Statistical Consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Research deputy, School of Medicine, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8081
Email
al.mehrabi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Taghi Hashemi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of anesthesiology, Alzahra hospital, Soffeh St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
Email
st_hashemi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
Statistical Consultani
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Research deputy, School of Medicine, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8081
Email
al.mehrabi@gmail.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
The data belongs to the government agency.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Because the study data is related to the government organization, there is no way to share it
When the data will become available and for how long
any time
To whom data/document is available
any person
Under which criteria data/document could be used
Under no circumstances
From where data/document is obtainable
any person
What processes are involved for a request to access data/document