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

NCT01444703 | Completed

• 1 other identifier: 332/2010
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

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.

Conditions

Sore Throat

Keywords

Thoracic surgery; double-lumen endotracheal tube; intubation; extubation; sore throat; prevention of post-extubation sore throat

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• post-extubation coughing

  up to four hours post-extubation

• amount of coughing

  24 hours post operative

• sore throat in rest

  first 24 hours after surgrey

• incidence of sore throat during swallowing

  first 24 hours after surgery

Study Arms (2)

sugar solution

PLACEBO COMPARATOR

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

Other: sugar solution

licorice

ACTIVE COMPARATOR

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

Other: licorice solution

Interventions

licorice solution OTHER

licorice (0.5 g)

licorice

sugar solution OTHER

sugar (5 g).

sugar solution

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

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

Vienna, Austria

Location

Related 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 Sep;117(3):614-621. doi: 10.1213/ANE.0b013e318299a650. Epub 2013 Aug 6.

  PMID: 23921656 RESULT

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Daniel Sessler, MD

  Outcomes Research Consortium, Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Outcomes Research Consortium

Study Record Dates

• First Submitted: September 23, 2011
• First Posted: October 3, 2011
• Study Start: October 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 20, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)