Preoperative Gum Chewing for Different Durations to Prevent Sore Throat After Endotracheal Intubation

Preoperative Gum Chewing for Different Durations to Prevent Sore Throat After Endotracheal Intubation: A Randomized Controlled Trial

This study aims to evaluate the effect preoperative chewing gums for 2 or 4 minutes on postoperative sore throat after general anesthesia using an endotracheal tube.

Study Overview

• Status: Completed
• Conditions: Endotracheal Intubation; Randomized Controlled Trial; Sore Throat; Gum Chewing
• Intervention / Treatment: Dietary supplement: Gum chewing for 2 minutes; Dietary supplement: Gum chewing for 4 minutes

Detailed Description

Pharmacological measures for attenuating postoperative sore throat (POST) include inhalation of beclomethasone or fluticasone propionate; gargling with azulene sulfonate, aspirin, or ketamine: gargling or spraying benzydamine hydrochloride; intravenous (IV) dexamethasone; oral clonidine; topical or systemic lidocaine; and ingestion of strepsils tablets. Each of these approaches has limitations and variable success rates; thus, no approach has become established in routine clinical use. In the past decade, studies have shown that xylitol in chewing gum may inhibit the growth, metabolism, and polysaccharide production of Streptococcus mutans, which accounts for the highest proportion of the natural flora in the oral cavity. Subsequent biofilm formation reduction may lead to some reduction in the number of bacteria. Furthermore, chewing gum can promote salivary gland secretion, resulting in lubrication and cleansing of the oral cavity. which may decrease postoperative sore throat.

Patients included in the study will be divided into 3 groups; the gum group2 (group G2), the gum group4 (group G4) and the control group (group C) by a computer-generated random number table before surgery. In the preoperative waiting area before transfer to the operating room, patients in group G2 will chew 1 piece of herbal sugar-free for 2 minutes and then spat it out, patients in group G4 will chew 1 piece of herbal sugar-free for 4 minutes and then spat it out, group C will be asked to swallow 2 times only. After entering to the OR patients will be routinely monitored with ECG, Pulse oximetry, and blood pressure then induction of anesthesia will be done using Fentanyl 1 to 2 mcg per kg, propofol 1 to 3 mg per kg, and atracurium 0.6 mg per kg. endotracheal tube size 7.5 will be inserted. volume-controlled ventilation was initiated with a mixture of 50% oxygen and 50% air, a respiratory rate of 12 cycles·minute, an inspiratory-to-expiratory ratio (I:E) of 1:2 and an adjusted end-tidal CO2 maintained at approximately 35-40 mm Hg. Ondansetron (4 mg) and paracetamol 1g were injected IV to prevent postoperative nausea, vomiting, and pain. Patients will be extubated after being awake using minimal suction. Postoperative sore throat (POST) will be evaluated by the numerical rating scale (NRS), which ranges from 0 to 10 points, with 0 indicating no pain, 1-3 indicating mild discomfort, 4-6 indicating moderate pain, and 7-10 indicating severe pain.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11561
    • National Cancer Institute - Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Age 21-65 years
4. Females
5. American Society of Anesthesiologists (ASA) physical I-II
6. Scheduled for elective breast surgery
7. Under general anesthesia.

Exclusion Criteria:

1. Chronic laryngitis
2. Chronic bronchitis
3. Asthma
4. Gastroesophageal reflux
5. Allergies to study drugs
6. Recent use of nonsteroidal anti-inflammatory drugs (NSAIDs)
7. A history of upper respiratory tract infection
8. Smoking and steroid therapy in the past week
9. Failure to communicate normally
10. Mallampati grade >2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Gum chewing for 2 minutes; Patients will chew 1 piece of herbal sugar-free for 2 minutes and then spat it out.	Dietary supplement: Gum chewing for 2 minutes; In the preoperative waiting area before transfer to the operating room, patients will chew 1 piece of herbal sugar-free for 2 minutes and then spat it out.
EXPERIMENTAL: Gum chewing for 4 minutes; Patients will chew 1 piece of herbal sugar-free for 4 minutes and then spat it out.	Dietary supplement: Gum chewing for 4 minutes; In the preoperative waiting area before transfer to the operating room, patients will chew 1 piece of herbal sugar-free for 4 minutes and then spat it out.
NO_INTERVENTION: Control group; Patients will be asked to swallow 2 times only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of moderate/severe postoperative sore throat (POST) within 24 hours after surgery POST within 24 hours after surgery	The incidence of moderate/severe POST within 24 hours after surgery	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative sore throat (POST) numeric rating scale (NRS) scores 2, 6, and 24 hours after surgery	POST will be evaluated by the numerical rating scale (NRS), which ranges from 0 to 10 points, with 0 indicating no pain, 1-3 indicating mild discomfort, 4-6 indicating moderate pain, and 7-10 indicating severe pain. The higher is worse.	24 hours Postoperative

Collaborators and Investigators

• Sponsor: Ahmed Salah Ahmed Abd Elgalil

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2021
• Primary Completion (ACTUAL): October 25, 2022
• Study Completion (ACTUAL): October 26, 2022

Study Registration Dates

• First Submitted: September 25, 2021
• First Submitted That Met QC Criteria: September 25, 2021
• First Posted (ACTUAL): October 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis
• Other Study ID Numbers: AP2106-50108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon reasonable request from the corresponding author
• IPD Sharing Time Frame: One year after the end of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No