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Comparison of Licorice Versus Sugar-water Gargle for Prevention of Postoperative Sore Throat and Postextubation Coughing

Primary Purpose

Sore Throat

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
licorice solution
sugar solution
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sore Throat focused on measuring Thoracic surgery, double-lumen endotracheal tube, intubation, extubation, sore throat, prevention of post-extubation sore throat

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Thoracic surgery with anticipated use of a double-lumen endotracheal tube;
  • Anticipated extubation in the operating room;
  • ASA Physical Status 1-3;
  • Age 18- 90

Exclusion Criteria:

  • Tracheal pathology, including tracheostomy;
  • Surgery within the previous four weeks;
  • Upper-respiratory tract infection;
  • BMI higher exceeding 40 kg/m2;
  • Known or suspected allergy to licorice;
  • Use of non-steroidal anti-inflammatory drug medication within 24 hours;
  • Chronic opioid use;
  • Preoperative pain ≥ 2 on an 11-point Likert scale (0 = no pain; 10 = worst pain);
  • Known or suspected difficult airway.

Sites / Locations

  • Universitätsklinik für Anästhesie, Intensivmedizin und Schmerztherapie an der medizinischen Universität Wien

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

sugar solution

licorice

Arm Description

Gargle 5 minutes before induction of general anesthesia with sugar solution.

Gargle 5 minutes before induction of general anesthesia with licorice solution.

Outcomes

Primary Outcome Measures

sore throat in rest after intubation
We propose to test the hypothesis that pre-operative gargling with licorice reduces the incidence of sore throat in rest after intubation with double-lumen endotracheal tubes compared to placebo after surgery through the first four post-extubation hours.

Secondary Outcome Measures

post-extubation coughing
Pre-operative gargling with licorice reduces sore throat pain during the initial postoperative day. Pre-operative gargling with licorice reduces the incidence of post-extubation coughing.
amount of coughing
Pre-operative gargling with licorice reduces the amount of coughing during the remainder of the first postoperative day.
sore throat in rest
Pre-operative gargling with licorice reduces the incidence of sore throat in rest and during swallowing within the first 24 hours
incidence of sore throat during swallowing
Pre-operative gargling with licorice reduces the incidence of sore throat in rest and during swallowing within the first 24 hours

Full Information

First Posted
September 23, 2011
Last Updated
July 19, 2016
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01444703
Brief Title
Comparison of Licorice Versus Sugar-water Gargle for Prevention of Postoperative Sore Throat and Postextubation Coughing
Official Title
Randomized, Double-blind Comparison of Licorice Versus Sugar-water Gargle for Prevention of Postoperative Sore Throat and Postextubation Coughing
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators propose to test the hypothesis that pre-operative gargling with licorice reduces the incidence of sore throat in rest after intubation with double-lumen endotracheal tubes compared to placebo after surgery through the first four post-extubation hours.
Detailed Description
Patients will be premedicated with up to 7.5 mg p.o. midazolam, per routine. They will be told that the study involves two different solutions for prevention of post-extubation sore throat. Patients will be randomly assigned to gargle 5 minutes before induction of general anesthesia with: 1) licorice (0.5 g); or, 2) sugar (5 g). Randomization will be based on a computer-generated table of random numbers. Licorice or sugar (placebo) will be diluted in 30 ml water and filled in a small bottle by an independent apothecary of our university. All bottles will look similar and will not be opened until just before use. Investigator and patient will be blinded to the preparation used for gargle. Patients will be asked to gargle for two minutes, but not to swallow the solution. General anesthesia will be induced with fentanyl ≈3 µg/kg, propofol ≈1.5 mg/kg, and rocuronium ≈0.6 mg/kg. Complete muscle relaxation will be confirmed by absence of palpable twitches in response to supra-maximal train-of-four stimulation of the ulnar nerve at the wrist. The trachea will then be intubated as gentle as possible. Intubation will be attempted with a Macintosh laryngoscope, but the anesthesiologists may subsequently use any other intubation equipment as necessary. Initial tube size will be 37 cm left in women and 39 cm left for men; however, other sizes can be used if clinically necessary. Endotracheal tube cuffs will be inflated with air to 20-25 mmHg as necessary to maintain an adequate seal. General anesthesia will be primarily be maintained with sevoflurane. Patients lungs will be ventilated with O2 in air, usually with an inspired oxygen fraction (FiO2) of ≈40%. However, additional oxygen will be provided as clinically necessary, especially during one-lung ventilation. End-tidal CO2 will be maintained between 32 and 35 mmHg as clinically practical. Deep of anesthesia will be monitored by using bispectral index BIS, kept between 40 and 50. Small amounts of opioid will be permitted during surgery and in preparation for extubation. At the end of surgery, an intercostal plexus block -using up to 20 ml Ropivacaine 0.1% - will be performed by the surgeons. 1000 mg paracetamol will be given intravenously ten minutes before end of surgery. Post operative pain will be treated with fractional piritramid (Dipidolor) 3 mg IV as required.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat
Keywords
Thoracic surgery, double-lumen endotracheal tube, intubation, extubation, sore throat, prevention of post-extubation sore throat

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sugar solution
Arm Type
Placebo Comparator
Arm Description
Gargle 5 minutes before induction of general anesthesia with sugar solution.
Arm Title
licorice
Arm Type
Active Comparator
Arm Description
Gargle 5 minutes before induction of general anesthesia with licorice solution.
Intervention Type
Other
Intervention Name(s)
licorice solution
Intervention Description
licorice (0.5 g)
Intervention Type
Other
Intervention Name(s)
sugar solution
Intervention Description
sugar (5 g).
Primary Outcome Measure Information:
Title
sore throat in rest after intubation
Description
We propose to test the hypothesis that pre-operative gargling with licorice reduces the incidence of sore throat in rest after intubation with double-lumen endotracheal tubes compared to placebo after surgery through the first four post-extubation hours.
Time Frame
up to 4 hours post-extubation
Secondary Outcome Measure Information:
Title
post-extubation coughing
Description
Pre-operative gargling with licorice reduces sore throat pain during the initial postoperative day. Pre-operative gargling with licorice reduces the incidence of post-extubation coughing.
Time Frame
up to four hours post-extubation
Title
amount of coughing
Description
Pre-operative gargling with licorice reduces the amount of coughing during the remainder of the first postoperative day.
Time Frame
24 hours post operative
Title
sore throat in rest
Description
Pre-operative gargling with licorice reduces the incidence of sore throat in rest and during swallowing within the first 24 hours
Time Frame
first 24 hours after surgrey
Title
incidence of sore throat during swallowing
Description
Pre-operative gargling with licorice reduces the incidence of sore throat in rest and during swallowing within the first 24 hours
Time Frame
first 24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Thoracic surgery with anticipated use of a double-lumen endotracheal tube; Anticipated extubation in the operating room; ASA Physical Status 1-3; Age 18- 90 Exclusion Criteria: Tracheal pathology, including tracheostomy; Surgery within the previous four weeks; Upper-respiratory tract infection; BMI higher exceeding 40 kg/m2; Known or suspected allergy to licorice; Use of non-steroidal anti-inflammatory drug medication within 24 hours; Chronic opioid use; Preoperative pain ≥ 2 on an 11-point Likert scale (0 = no pain; 10 = worst pain); Known or suspected difficult airway.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Sessler, MD
Organizational Affiliation
Outcomes Research Consortium, Cleveland Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Universitätsklinik für Anästhesie, Intensivmedizin und Schmerztherapie an der medizinischen Universität Wien
City
Vienna
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23921656
Citation
Ruetzler K, Fleck M, Nabecker S, Pinter K, Landskron G, Lassnigg A, You J, Sessler DI. A randomized, double-blind comparison of licorice versus sugar-water gargle for prevention of postoperative sore throat and postextubation coughing. Anesth Analg. 2013 Sep;117(3):614-621. doi: 10.1213/ANE.0b013e318299a650. Epub 2013 Aug 6.
Results Reference
result

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Comparison of Licorice Versus Sugar-water Gargle for Prevention of Postoperative Sore Throat and Postextubation Coughing

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