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

This study has been completed.
Sponsor:
Collaborator:
Department of Cardiothoracic and Vascular Anesthesia and Intensive Care Medicine
Information provided by (Responsible Party):
Daniel I. Sessler, M.D., Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT01444703
First received: September 23, 2011
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Sore Throat
Other: licorice solution
Other: sugar solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Randomized, Double-blind Comparison of Licorice Versus Sugar-water Gargle for Prevention of Postoperative Sore Throat and Postextubation Coughing

Resource links provided by NLM:


Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • sore throat in rest after intubation [ Time Frame: up to 4 hours post-extubation ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to four hours post-extubation ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 hours post operative ] [ Designated as safety issue: No ]
    Pre-operative gargling with licorice reduces the amount of coughing during the remainder of the first postoperative day.

  • sore throat in rest [ Time Frame: first 24 hours after surgrey ] [ Designated as safety issue: No ]
    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 [ Time Frame: first 24 hours after surgery ] [ Designated as safety issue: No ]
    Pre-operative gargling with licorice reduces the incidence of sore throat in rest and during swallowing within the first 24 hours


Enrollment: 236
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: sugar solution
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).
Other: sugar solution
sugar (5 g).
Active Comparator: licorice
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).
Other: licorice solution
licorice (0.5 g)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444703

Locations
Austria
Universitätsklinik für Anästhesie, Intensivmedizin und Schmerztherapie an der medizinischen Universität Wien
Vienna, Austria
Sponsors and Collaborators
Outcomes Research Consortium
Department of Cardiothoracic and Vascular Anesthesia and Intensive Care Medicine
Investigators
Study Chair: Daniel Sessler, MD Outcomes Research Consortium, Cleveland Clinic
  More Information

No publications provided

Responsible Party: Daniel I. Sessler, M.D., Chairman, Outcomes Research Consortium, Outcomes Research Consortium
ClinicalTrials.gov Identifier: NCT01444703     History of Changes
Other Study ID Numbers: 332/2010
Study First Received: September 23, 2011
Last Updated: September 29, 2011
Health Authority: Austria: Ethikkommission

Keywords provided by Outcomes Research Consortium:
Thoracic surgery
double-lumen endotracheal tube
intubation
extubation
sore throat
prevention of post-extubation sore throat

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 29, 2014