The effect of nasal packing at night before surgery on patient agitation after rhinoplasty
Design
Clinical trial, single-blind, has a control group, parallel, randomized
Settings and conduct
Patients will be divided into two groups: control and intervention.
The intervention group will be blocked by the plastic cap on the night before the rhinoplasty is performed for one hour and will only breathe through the mouth.
Patients in the control group will not receive any action.
Participants/Inclusion and exclusion criteria
Entry criteria: ASA Class 1 and 2, and BMI less than 30
Exit criteria: Smoking
Intervention groups
The intervention group will be blocked by the plastic cap on the night before the rhinoplasty is performed for one hour and will only breathe through the mouth.
Main outcome variables
Agitation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N1
Registration date:2019-03-30, 1398/01/10
Registration timing:prospective
Last update:2019-03-30, 1398/01/10
Update count:0
Registration date
2019-03-30, 1398/01/10
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-20, 1398/02/30
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nasal packing at night before surgery on patient agitation after rhinoplasty
Public title
The effect of nasal packing on patient agitation after rhinoplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ASA Class 1 and 2
BMI below 30
Exclusion criteria:
Smoking
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are simply randomized to two groups , through random number table; received a special code and are treated with own group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2019-01-07, 1397/10/17
Ethics committee reference number
IR.TBZMED.REC.1397.827
Health conditions studied
1
Description of health condition studied
Agitation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Agitation
Timepoint
5 minutes for 45 minutes
Method of measurement
Riker Sedation Agitation Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For one hour before the night of rhinoplasty, nasal holes will be blocked by plastic clips and breathing will be done through the mouth.
Category
Treatment - Devices
2
Description
Control group: There will be no work for this group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mahmoud Eydi
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6165665631
Phone
+98 21 3335 5921
Email
mkhanbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mahmoud Eydi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Mkhanbabayi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahmoud Eydi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Mkhanbabayi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@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
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