Investigation the effect of local anesthesia in nasal mucosa with %0.5 tetracaine drop on hemodynamic changes, bleeding during surgery and pain after surgery in septoplasty.
The aim of this study is Investigation the effect of local anesthesia in nasal mucosa with %0.5 tetracaine drop on hemodynamic changes, bleeding during surgery and pain after surgery in septoplasty. This study is a double blind clinical trial.This study is done on patients candidate for septoplasty who are 15-35 years old with ASAI and II .
Exclusion criteria: History of hypersensitivity to tetracaine or other local anesthetic drugs, history of using analgesics more than 5 days continuously in last month, history of drug abuse. weight more than 100 kg or less than 30kg, history of hypertension. Sample size is 62.Patients are divided into two groups. In the first group, dipped cotton in 10 drops of %0.5 tetracaine is put in each nasal cavity. in the second group, dipped cotton in normal saline is put in each nasal cavity. this study has down between 22/12/2013 and 20/11/2014. The outcomes of study are heart rate, blood pressure, restlessness and pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201505266252N8
Registration date:2015-07-17, 1394/04/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-17, 1394/04/26
Registrant information
Name
Soroush Amani
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1226 4834
Email address
samani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences.
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-11-20, 1393/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of local anesthesia in nasal mucosa with %0.5 tetracaine drop on hemodynamic changes, bleeding during surgery and pain after surgery in septoplasty.
Public title
Investigation the effect of local anesthesia in nose with %0.5 tetracaine drop on blood pressure, bleeding during surgery and pain after surgery in septoplasty.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The 15-35 years old patients with ASAI and II that candidate for septoplasty.
Exclusion criteria: History of hypersensitivity to tetracaine or other local anesthetic drugs, history of using analgesics more than 5 days continuously in last month, history of drug abuse. weight more than 100 kg or less than 30kg, history of hypertension.
Age
From 15 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciencies
Street address
Kashani Avenue, Shahrekord
City
Shahrekod
Postal code
8815713471
Approval date
2013-11-27, 1392/09/06
Ethics committee reference number
1805
Health conditions studied
1
Description of health condition studied
Septal deviation
ICD-10 code
J34.2
ICD-10 code description
Deviated nasal septum
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
5 minute before anesthesia, 10, 15 and 20 minute after anesthesia
Method of measurement
with manometer
2
Description
Diastolic blood presure
Timepoint
5 minute before anesthesia, 10, 15 and 20 minute after anesthesia
Method of measurement
with manometer
3
Description
Pulse rate
Timepoint
5 minute before anesthesia, 10, 15 and 20 minute after anesthesia
Method of measurement
with pulse oxymeter
Secondary outcomes
1
Description
pain and restlessness
Timepoint
10 minutes after enterance to recovery and 70 minutes after end of surgery
Method of measurement
VAS questionnaire
Intervention groups
1
Description
In the first group, dipped cotton in 10 drops of %0.5 tetracaine is put in each nasal cavity.
Category
Treatment - Drugs
2
Description
in the second group, dipped cotton in normal saline is put in each nasal cavity.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Soroush Amani MD
Street address
Shariati Avenue, Shahrekord
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Mahmood Mobasheri MD
Street address
Kashani Avenue, Shahrekord
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Soroush Amani MD
Position
Otolaryngologist
Other areas of specialty/work
Street address
Kashani Avenue, Shahrekord
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3334 9506
Fax
+98 38 3334 3004
Email
info@Skums.ac.ir
Web page address
http://www.SKUMS.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Soroush Amani MD
Position
Otolaryngologist
Other areas of specialty/work
Street address
Kashani Avenue, Shahrekord
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3333 0061
Fax
+98 38 3334 3004
Email
info@Skums.ac.ir
Web page address
http://www.SKUMS.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Soroush Amani MD
Position
Otolaryngologist
Other areas of specialty/work
Street address
Kashsni Avenue, Shahrekord
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3333 0061
Fax
+98 38 3334 3004
Email
info@Skums.ac.ir
Web page address
http://www.SKUMS.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)