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

Sponsor
Ahmed Salah Ahmed Abd Elgalil (Other)
Overall Status
Recruiting
CT.gov ID
NCT05069844
Collaborator
(none)
150
1
3
8
18.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Gum chewing for 2 minutes
  • Dietary Supplement: Gum chewing for 4 minutes
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Preoperative Gum Chewing for Different Durations to Prevent Sore Throat After Endotracheal Intubation: A Randomized Controlled Trial
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The incidence of moderate/severe postoperative sore throat (POST) within 24 hours after surgery POST within 24 hours after surgery [24 hours postoperative]

    The incidence of moderate/severe POST within 24 hours after surgery

Secondary Outcome Measures

  1. Postoperative sore throat (POST) numeric rating scale (NRS) scores 2, 6, and 24 hours after surgery [24 hours Postoperative]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Cancer Institute - Egypt Cairo Egypt 11561

Sponsors and Collaborators

  • Ahmed Salah Ahmed Abd Elgalil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Salah Ahmed Abd Elgalil, Lecturer of Anesthesiology and Pain Management, National Cancer Institute, Egypt
ClinicalTrials.gov Identifier:
NCT05069844
Other Study ID Numbers:
  • AP2106-50108
First Posted:
Oct 6, 2021
Last Update Posted:
Apr 19, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2022