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

NCT ID: NCT05069844

Last Updated: 2022-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-10-26

Brief Summary

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.

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.

Conditions

Gum Chewing; Sore Throat; Endotracheal Intubation; Randomized Controlled Trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Gum chewing for 2 minutes

Patients will chew 1 piece of herbal sugar-free for 2 minutes and then spat it out.

Group Type: EXPERIMENTAL

Gum chewing for 2 minutes

Intervention Type: DIETARY_SUPPLEMENT

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.

Gum chewing for 4 minutes

Patients will chew 1 piece of herbal sugar-free for 4 minutes and then spat it out.

Group Type: EXPERIMENTAL

Gum chewing for 4 minutes

Intervention Type: DIETARY_SUPPLEMENT

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.

Control group

Patients will be asked to swallow 2 times only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ahmed Salah Ahmed Abd Elgalil

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Salah Ahmed Abd Elgalil

Lecturer of Anesthesiology and Pain Management

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

National Cancer Institute - Egypt

Cairo, , Egypt

Countries

Egypt

Other Identifiers

AP2106-50108

Identifier Type: -

Identifier Source: org_study_id