Investigation of the effect of impregnation of endotracheal tube cuff with diltiazem gel on cardiovascular changes in patients undergoing laparoscopic cholecystectomy Surgery.
Determination of the effect of impregnation of endotracheal tube cuff with diltiazem gel on cardiovascular changes in patients undergoing laparoscopic cholecystectomy Surgery
Design
Clinical trial with control group and parallel group, blinded , simple randomized
Settings and conduct
In the experimental group, the cuff of the endotracheal tube was impregnated with diltiazem gel, and in the control group , the lubricating gel was used for cuff. The gels were named by the research colleague of two types A and B, and the researcher and the patient were unaware of the gel type.
In patients undergoing Cholecystectomy Surgery by Laparoscopic,
the diltiazem gel is applied to the cuff of the endotracheal tube and its effect on cardiovascular disorders is investigated.
Main outcome variables
Blood pressure, heart rate, arrhythmia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190307042957N1
Registration date:2019-04-29, 1398/02/09
Registration timing:retrospective
Last update:2019-04-29, 1398/02/09
Update count:0
Registration date
2019-04-29, 1398/02/09
Registrant information
Name
yarhosain safari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 3963
Email address
w.office@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
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
Investigation of the effect of impregnation of endotracheal tube cuff with diltiazem gel on cardiovascular changes in patients undergoing laparoscopic cholecystectomy Surgery.
Public title
Investigation of the effect of diltiazem gel on cardiovascular changes in patients undergoing cholecystectomy Surgery.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Having gallstones
Exclusion criteria:
Dysrhythmia
Myocardial infarction
Hypertension history
Pregnancy
Age
From 16 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomized (Random numbers table)
Blinding (investigator's opinion)
Double blinded
Blinding description
Both researcher and subjects were blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blv., Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6719995364
Approval date
2018-10-16, 1397/07/24
Ethics committee reference number
IR.KUMS.REC.1397.569
Health conditions studied
1
Description of health condition studied
Gallstones
ICD-10 code
K80.1
ICD-10 code description
Calculus of gallbladder with other cholecystitis
Primary outcomes
1
Description
Blood pressure
Timepoint
Before the intubation, immediately after the intubation and 5 minutes after the intubation, during the surgery every 15 minutes, at entering the recovery, 15 and 30 minutes after entering the recovery
Method of measurement
Based on monitoring device
2
Description
Cardiac Dysrhythmia
Timepoint
Before the intubation, immediately after the intubation and 5 minutes after the intubation, during the surgery every 15 minutes, at entering the recovery, 15 and 30 minutes after entering the recovery
Method of measurement
Based on recovery device
3
Description
Heart rate
Timepoint
Before the intubation, immediately after the intubation and 5 minutes after the intubation, during the surgery every 15 minutes, at entering the recovery, 15 and 30 minutes after entering the recovery
Method of measurement
Based on recovery device
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, induction of anesthesia with 2 mg / kg Propofol and Atracurium 0.5 mg / kg is performed, then, the trachea cuff is impregnated with Lubricant water soluble gel
Category
Treatment - Other
2
Description
In the second intervention group, induction of anesthesia with 2 mg / kg Propofol and Atracurium 0.5 mg / kg is performed, then is impregnated with 0.2% water-soluble sterilizing Diltiazem gel(Polygell, manufactured by Paliz Iranian medicine).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr Yarhosain Safari
Street address
Parastar ave. Emam Reza Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6719995364
Phone
+98 83 3827 3963
Email
w.office@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farid Najafi
Street address
Shahid Beheshti Ave.,Department of Kermanshah Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6719995364
Phone
+98 83 3835 3860
Email
w.office@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
50
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
Kermanshah University of Medical Sciences
Full name of responsible person
Parastoo Abaspour
Position
clerk
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti blv., Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6719995364
Phone
+98 83 3836 8865
Email
W.office@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Javad Amini Saman
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Parastar ave., Emam Reza Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6719995364
Phone
+98 83 3836 7397
Email
aminisamanj99@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Parastoo Abaspour
Position
clerk
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti Blv., Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6719995364
Phone
+98 83 3835 3860
Email
W.office@kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is shared
When the data will become available and for how long
Start the access period one year after the print results
To whom data/document is available
All researchers
Under which criteria data/document could be used
Use for future research
From where data/document is obtainable
Kermanshah University of Medical Sciences
What processes are involved for a request to access data/document