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

Sore Throat Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444703
• Other study ID #: 332/2010
• Status: Completed
• Phase: N/A
• First received: September 23, 2011
• Last updated: July 19, 2016
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: July 2016
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pharyngitis
• Sore Throat

Intervention

Other:
• licorice solution
licorice (0.5 g)
• sugar solution
sugar (5 g).

Locations

Country	Name	City	State
Austria	Universitätsklinik für Anästhesie, Intensivmedizin und Schmerztherapie an der medizinischen Universität Wien	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 4 hours post-extubation	No
Secondary	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.	up to four hours post-extubation	No
Secondary	amount of coughing	Pre-operative gargling with licorice reduces the amount of coughing during the remainder of the first postoperative day.	24 hours post operative	No
Secondary	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	first 24 hours after surgrey	No
Secondary	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	first 24 hours after surgery	No