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An evaluation of the efficacy of different doses of licorice gargling for attenuating postoperative sore throat after tracheal intubation

Protocol summary

Summary
This study was designed to evaluate the efficacy of different doses of licorice on postoperative sore throat and postextubation cough. Patients with ages between 18 and 65, undergoing any operation other than head and neck surgery with general anesthesia for their first time were included to the study, and those with any change in the method or frequency of anesthesia, intubation or extubation were excluded. In this double blind clinical trial, 144 patients were randomly allocated to four groups of 36 patients to gargle doses of zero (control), 0.25, 0.5, and one gram of licorice in 30 milliliter of water before general anesthesia and operation. Then sore throat in rest and swallowing position in zero, two, four, and 24 hours postoperation, and postextubation cough, were evaluated and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201411115362N21
Registration date: 2015-01-19, 1393/10/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-19, 1393/10/29
Registrant information
Name
Mohammadreza Safavi
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1273 2659
Email address
safavi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-01-01, 1391/10/12
Expected recruitment end date
2014-10-31, 1393/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An evaluation of the efficacy of different doses of licorice gargling for attenuating postoperative sore throat after tracheal intubation
Public title
Licorice gargling to decrease sore throat after surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Patients underwent any operation other than head and neck surgery under general anesthesia; aged between 18 and 65 years; with American Society of Anesthesia (ASA) physical status I and II; no NSAID use; no perioperative corticosteroid intake (from 24 hours before operation); no allergy or intolerance to licorice; no upper respiratory tract infection; without mallampati grade more than two. Exclusion criteria: Any change in anesthetic technique; requiring more than one attempt for intubation; not being extubated at the end of the surgery; re-intubation within the study period.
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: 144
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezarjarib Street
City
Isfahan
Postal code
Approval date
2012-06-13, 1391/03/24
Ethics committee reference number
391132

Health conditions studied

1

Description of health condition studied
Postoperative Sore Throat (POST)
ICD-10 code
R07.0
ICD-10 code description
Pain in throat

2

Description of health condition studied
Postextubation Cough
ICD-10 code
R05
ICD-10 code description
Cough

Primary outcomes

1

Description
Postoperative Sore Throat
Timepoint
0, 2, 4, and 24 hours after operation
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Postextubation Cough
Timepoint
after extubation
Method of measurement
Observation

2

Description
Patient Satisfation
Timepoint
24 hours after operation
Method of measurement
Likert form asked from patient (very satisfied, satisfied, no opinion, dissatisfied, very dissatisfied)

Intervention groups

1

Description
Group A: Licorice (Gargling, 0.25 gram Licorice in 30 ml of water, 5min before operation, for 30 seconds)
Category
Prevention

2

Description
Group B: Licorice (Gargling, 0.5 gram Licorice in 30 ml of water, 5min before operation, for 30 seconds)
Category
Treatment - Drugs

3

Description
Group C: Licorice (Gargling, 1 gram Licorice in 30 ml of water, 5min before operation, for 30 seconds)
Category
Treatment - Drugs

4

Description
Group D (Control group): Placebo (Gargling, only 30 ml of water, 5min before operation, for 30 seconds)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Dr. Azim Honarmand
Street address
Ayatollah Kashani Hospital, Ayatollah Kashani Street, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mansur Siavash
Street address
Hezarjarib Street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Mohammadreza Safavi
Position
Associat Professor
Other areas of specialty/work
Street address
Hezarjarib Street
City
Isfahan
Postal code
Phone
+98 913 315 2416
Fax
Email
safavi@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Mohammadreza Safavi
Position
Associate Professor
Other areas of specialty/work
Street address
Hezarjarib Street
City
Isfahan
Postal code
Phone
+98 913 315 2416
Fax
Email
safavi@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Mohammadreza Safavi
Position
Associate Professor
Other areas of specialty/work
Street address
Hezarjarib Street
City
Isfahan
Postal code
Phone
+98 913 315 2416
Fax
Email
Safavi@med.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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