Clinical trial NCT05069844: Preoperative Gum Chewing for Different Durations to Prevent Sore Throat After Endotracheal Intubation
Official title: Preoperative Gum Chewing for Different Durations to Prevent Sore Throat After Endotracheal Intubation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gum Chewing
Sore Throat
Endotracheal Intubation
Randomized Controlled Trial
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 150
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The incidence of moderate/severe postoperative sore throat (POST) within 24 hours after surgery POST within 24 hours after surgery
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Postoperative sore throat (POST) numeric rating scale (NRS) scores 2, 6, and 24 hours after surgery
timeFrame: 24 hours Postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute - Egypt
Study officials:
References: