A comparison between intravenous and topical spray of lidocaine on hemodynamic changes and discomfort feeling in throat/larynge following to LMA insertion in general anesthesia
A comparison between intravenous and topical spray of lidocaine on hemodynamic changes and discomfort feeling in throat/larynge following to LMA insertion in general anesthesia
Design
A randomized clinical trial without control group, with parallel groups, phase 3، without blindness that, 120 patients randomly divided into two groups of 60 subjects with block sizes of 4 and 6.
Settings and conduct
The population of this study was aged 18-65 years old who referred to Ayatollah Rouhani Hospital in Babol. randomly divided into two Intervention groups with block sizes of 4 and 6.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 18-65 years old, ASA class I-II
Exclusion Criteria: History of laryngeal or tracheal surgery, History of allergic reaction, Smoking, Addiction
Intervention groups
Intervention Group 1: Three minutes before LMA placement, 1.5 mg / kg intravenous lidocaine (Aborihan Comany) and normal saline (Samen Company) spray are given at the bottom of the throat.
Intervention Group2: Three minutes before LMA placement, the patient's pharynx is smeared with 2% lidocaine spray (Kharazmi Company) (0.1ml / puff) and the entire LMA cuff is soaked with lidocaine gel 2% (Sina daro Company) before placement.
Main outcome variables
Blood Pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141121020020N5
Registration date:2020-06-06, 1399/03/17
Registration timing:registered_while_recruiting
Last update:2020-06-06, 1399/03/17
Update count:0
Registration date
2020-06-06, 1399/03/17
Registrant information
Name
Shahram Seyfi
Name of organization / entity
Babol University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8284
Email address
sh.seyfi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-18, 1398/11/29
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between intravenous and topical spray of lidocaine on hemodynamic changes and discomfort feeling in throat/larynge following to LMA insertion in general anesthesia
Public title
A comparison between intravenous and topical spray of lidocaine on discomfort feeling in throat/larynge in general anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
18-65 years old
ASA class I-II
Exclusion criteria:
History of laryngeal or tracheal surgery,
History of allergic reaction
Smoking
Addiction
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients into two intervention groups Patients are randomly divided into two groups A and B with a table of random numbers (a random number table is a collection of numbers that are generated without a specific pattern or order and completely randomized, then samples are randomly selected by Randomizer software
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 Babol University Of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Approval date
2020-02-18, 1398/11/29
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.343
Health conditions studied
1
Description of health condition studied
General Anesthesia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Blood Pressure
Timepoint
Before and during intervention and after recovery time. 1, 3, 5, 10, 15 min after drug injection and 3, 5, 15, 30 min after recovery
Method of measurement
Blood pressure manometer by mmHg
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Three minutes before LMA placement, 1.5 mg / kg intravenous lidocaine (Aborihan Comany) and normal saline (Samen Company) spray are given at the bottom of the throat
Category
Prevention
2
Description
Intervention group: Three minutes before LMA placement, the patient's pharynx is smeared with 2% lidocaine spray (Kharazmi Company) (0.1ml / puff) and the entire LMA cuff is soaked with lidocaine gel 2% (Sina daro Company) before placement
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Shahram Seyfi
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 5308
Email
ficu_ss@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?