NCT02405832

Zinc Lozenges and Their Effect on Postoperative Sore Throat Syndrome

Completed NA Last updated 10 August 2018

What this trial tests

NA trial testing Zinc in Sore Throat in 87 participants. Completed in 4 April 2015.

Timeline

10 March 2015

Primary endpoint
4 April 2015

4 April 2015

Quick facts

Lead sponsor	University of Vermont
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	supportive care
Enrollment	87
Start date	10 March 2015
Primary completion	4 April 2015
Estimated completion	4 April 2015
Sites	1 location across United States

Drugs / interventions tested

• Zinc — full drug profile →
• Placebo

Conditions studied

• Sore Throat — all drugs for Sore Throat →
• Post-Operative Sore Throat — all drugs for Post-Operative Sore Throat →

Sponsor

University of Vermont

Who can join

18 and older, any sex, with Sore Throat or Post-Operative Sore Throat. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.