Zinc Lozenges and Their Effect on Postoperative Sore Throat Syndrome

NCT02405832 | Completed

• 1 other identifier: CHRMS 14-206
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the effect of preoperative administration of oral zinc lozenges on the incidence of postoperative sore throat syndrome. When patients undergo surgery with general anesthesia, they require ventilation of their lungs with the help of a flexible tube (called an endotracheal tube) that is placed through the mouth, passing the vocal cords, and into the windpipe (trachea). This tube helps oxygenate the patient, delivers anesthetic gas to the lungs, and keeps the airways open to prevent asphyxiation. The procedure is invasive and uncomfortable, and one of the most common consequences is a sore and inflamed throat after the tube is taken out. This is termed postoperative sore throat (POST). Though the intensity and severity of sore throat varies from person to person, the reported incidence is as high as 90% of patients undergoing general anesthesia. Zinc therapy has been shown in multiple studies to reduce the severity and duration of cold symptoms, and also to up-regulate the immune system. Recent studies have shown that zinc can act as an anti-inflammatory agent and can maintain the integrity of skin and mucosal membranes (which cover the inside of the mouth and throat). The aim of this study is to evaluate the effects of giving zinc lozenges before tube placement on postoperative sore throat. After written informed consent is received in pre-op, a sealed and coded envelope with either the zinc lozenge or the placebo lozenge will be given to the patient to be administered orally, with the instruction to dissolve the lozenge by sucking on it 30 minutes prior to surgery. Upon completion of surgery and emergence from general anesthesia, the patient will be extubated and transferred to the post-anesthesia care unit (PACU). Once in the PACU, the patient will be assessed regarding the incidence and severity of POST by the study investigator using a standardized scale. The severity of POST will be graded on a 4-point scale ranging from 0 to 3; 0 being no sore throat, 1 being mild discomfort (complains only upon questioning), 2 being moderate sore throat (complains on his/her own), and 3 being severe sore throat (change in voice, hoarseness, and throat pain). This evaluation will be performed at 30 minutes, 2 hours, 4 hours, and 24 hours post-surgery, with the assessment at 4 hours being the primary outcome of the study.

Conditions

Sore Throat; Post-Operative Sore Throat

Outcome Measures

Primary Outcomes (1)

• Severity of Post-Operative Sore Throat

  The severity of POST will be graded on a 4-point scale ranging from 0 to 3; 0 being no sore throat, 1 being mild discomfort (complains only upon questioning), 2 being moderate sore throat (complains on his/her own), and 3 being severe sore throat (change in voice, hoarseness, and throat pain).

  4 hours

Secondary Outcomes (3)

• Severity of Post-Operative Sore Throat at 30 minutes

  30 minutes

• Severity of Post-Operative Sore Throat at 2 hours

  2 hours

• Severity of Post-Operative Sore Throat at 24 hours

  24 hours

Study Arms (2)

Zinc - active arm

EXPERIMENTAL

Oral administration of a 40 mg elemental zinc (in the form of zinc sulfate) lozenge, with sweetener and citrus flavor

Dietary Supplement: Zinc

Placebo

PLACEBO COMPARATOR

Placebo lozenge, with sweetener and citrus flavor, administered orally

Dietary Supplement: Placebo

Interventions

Zinc DIETARY_SUPPLEMENT

Oral administration of a 40 mg elemental zinc (in the form of zinc sulfate) lozenge, with sweetener and citrus flavor

Zinc - active arm

Placebo DIETARY_SUPPLEMENT

Placebo lozenge, with sweetener and citrus flavor, administered orally

Placebo

Eligibility Criteria

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

You may qualify if:

• Men and women ages 18 and older
• American Society of Anesthesiologists physical status classification system I and II (healthy patient or patient with mild systemic disease)
• Patient coming for elective surgery (except head and neck) requiring general anesthesia
• Patients staying for at least 24 hours postoperatively
• Patients provide informed consent
• Patients presenting for surgery \>1 hour in length and \<6 hours.

You may not qualify if:

• History of preoperative sore throat, common colds, upper respiratory infections, immune deficiencies
• Chronic smokers
• Patients with Mallampati airway grade of more than 2
• Patients requiring more than one attempt for intubation or traumatic intubations
• Patients requiring laryngeal mask Airway (LMA) placement
• Patients allergic to zinc
• Patients requiring quinolones or tetracycline antibiotics pre- or intraoperatively
• Patients undergoing head and neck surgeries
• Pregnancy

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Related Publications (7)

• Arbabi-kalati F, Arbabi-kalati F, Deghatipour M, Ansari Moghadam A. Evaluation of the efficacy of zinc sulfate in the prevention of chemotherapy-induced mucositis: a double-blind randomized clinical trial. Arch Iran Med. 2012 Jul;15(7):413-7.

  PMID: 22724877 BACKGROUND

• Borazan H, Kececioglu A, Okesli S, Otelcioglu S. Oral magnesium lozenge reduces postoperative sore throat: a randomized, prospective, placebo-controlled study. Anesthesiology. 2012 Sep;117(3):512-8. doi: 10.1097/ALN.0b013e3182639d5f.

  PMID: 22797283 BACKGROUND

• Higgins PP, Chung F, Mezei G. Postoperative sore throat after ambulatory surgery. Br J Anaesth. 2002 Apr;88(4):582-4. doi: 10.1093/bja/88.4.582.

  PMID: 12066737 BACKGROUND

• 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 BACKGROUND

• Sharir H, Zinger A, Nevo A, Sekler I, Hershfinkel M. Zinc released from injured cells is acting via the Zn2+-sensing receptor, ZnR, to trigger signaling leading to epithelial repair. J Biol Chem. 2010 Aug 20;285(34):26097-106. doi: 10.1074/jbc.M110.107490. Epub 2010 Jun 3.

  PMID: 20522546 BACKGROUND

• Worthington HV, Clarkson JE, Bryan G, Furness S, Glenny AM, Littlewood A, McCabe MG, Meyer S, Khalid T. Interventions for preventing oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD000978. doi: 10.1002/14651858.CD000978.pub3.

  PMID: 21154347 BACKGROUND

• Farhang B, Grondin L. The Effect of Zinc Lozenge on Postoperative Sore Throat: A Prospective Randomized, Double-Blinded, Placebo-Controlled Study. Anesth Analg. 2018 Jan;126(1):78-83. doi: 10.1213/ANE.0000000000002494.

  PMID: 28953493 DERIVED

MeSH Terms

Conditions

Pharyngitis

Interventions

Zinc

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Lydia Grondin, M.D.

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology and Attending Anesthesiologist

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 1, 2015
• Study Start: March 10, 2015
• Primary Completion: April 4, 2015
• Study Completion: April 4, 2015
• Last Updated: August 10, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)