Hemodynamic changes in Patients undergoing Diagnostic Bronchoscopy using Remifentanil_ Propofol versus Remifentanil_ Ketamine
Design
In this search, 78 eligible Pulmonary Patients were Chosen purposefully for Diagnostic Bronchoscop and a code was allocated to each one of them. Then, patients were randomly divided into two intervention groups.
Settings and conduct
This study will be done at General Operation Room of Imam Khomeini hospital in Ardabil_ Iran. Type of study is Double blinde, That Kinde of sedative Drugs will be hiden from Both of bronchoscopist and Patient.
Participants/Inclusion and exclusion criteria
18 to 65 Y/O Patients with Pulmonary diseases (ASA 1_3) chosen for Diagnostic Bronchoscopy , without Uncontrolled Cardiovascular or carebral Diseases
Intervention groups
After Cardiopulmonary monitoring, One of the groups will be sedated by Remifentanil (0.1 microgram/kg/min) plus Propofol (0.5 mg/kg) and other groups by Remifentanil (0.1 microgram/kg/min) plus Ketamine (0.25 mg/kg) ].
Main outcome variables
Hemodynamic changes ( HR, SBP, DBP, MAP, Spo2) while Bronchoscopy and Consciousness state, Bronchoscopist & Patients consent at the End of Procedure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171202037716N1
Registration date:2017-12-13, 1396/09/22
Registration timing:prospective
Last update:2017-12-13, 1396/09/22
Update count:0
Registration date
2017-12-13, 1396/09/22
Registrant information
Name
Davood Seifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3352 1355
Email address
da.seifi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Hemodynamic Changes in Patients undergoing Diagnostic Bronchoscopy using Remifentanil_ Propofol versus Remifentanil_ Ketamine
Public title
Remifentanil_ Propofol versus Remifentanil_ Ketamine in Diagnostic Bronchoscopy
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 65 y/o Patients with Pulmonary Diseases ( ASA : 1_3 ) that selected by Pulmonologist for Diagnostic Bronchoscopy
Exclusion criteria:
Patients with Opioid addiction
Untreated HTN or IHD
Loss of Consciousness
Epileptic Patients
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:
76
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, Random allocation rule will be used , 76 Similar Closed packages will be performed: 38 Packages contain Blue Card ( Remifentanil_ propofol Group) and 38 Packages contain Green Card ( Remifentanil_ Ketamine Group), then Packages will be picked up and opened randomly without replacing and created sequence will be recorded.
Blinding (investigator's opinion)
Double blinded
Blinding description
Bronchoscopist and Patients will not be aware from the type of administrated drugs
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
ِDaneshgah Ave.
City
Ardabil
Province
Ardabil
Postal code
5618985991
Approval date
2017-10-30, 1396/08/08
Ethics committee reference number
IR.ARUMS.REC.1396.137
Health conditions studied
1
Description of health condition studied
Sedation for Diagnostic Bronchoscopy
ICD-10 code
R91
ICD-10 code description
Abnormal findings on diagnostic imaging of lung
Primary outcomes
1
Description
Percent of Systolic Blood Pressure Rising after Drugs administeration
Timepoint
Record of Systolic Blood Pressure Before, During and After Procedure
Method of measurement
Non invasive Manometer
Secondary outcomes
1
Description
Consciousness State of Patients
Timepoint
10 minutes after end of Procedure
Method of measurement
Ramsey Sedation Score
Intervention groups
1
Description
Intervention group: Remifentanil 0.1 microgram/kg/min Intra venously 3 min Before Procedure plus Propofol 0.5 mg/kg Intra venously
Category
Treatment - Other
2
Description
Intervention group: Remifentanil 0.1 microgram/kg/min Intra venously 3 min Before Procedure plus Ketamine 0.25 mg/kg Intra venously
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Doctor Hassan Gobadi
Street address
َAtaee Ave.
City
Ardabil
Province
Ardabil
Postal code
5618985991
Email
Emamhe@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Doctor Akhavan Akbari
Street address
Danashgah Ave.
City
Ardabil
Province
Ardabil
Postal code
5618985991
Email
info@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Davood Seifi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 27, Resalat 3 Ave. 13 Aban Ave.
City
Ardabil
Province
Ardabil
Postal code
5619814386
Phone
+98 45 3352 1355
Email
davood3565@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
ِDavood Seifi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 27, Resalat 3 Ave., 13 Aban Ave.
City
Ardabil
Province
Ardabil
Postal code
5619814386
Phone
+98 45 3352 1355
Email
Davood3565@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Davood Seifi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 27, Resalat 3 Ave., 13 Aban Ave.
City
Ardabil
Province
Ardabil
Postal code
5619814386
Phone
+98 45 3352 1355
Email
Davood3565@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
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