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

Primary Purpose

Gum Chewing, Sore Throat, Endotracheal Intubation

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Gum chewing for 2 minutes
Gum chewing for 4 minutes
Sponsored by
Ahmed Salah Ahmed Abd Elgalil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gum Chewing

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • National Cancer Institute - Egypt

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Gum chewing for 2 minutes

Gum chewing for 4 minutes

Control group

Arm Description

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

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

Patients will be asked to swallow 2 times only.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 25, 2021
Last Updated
November 18, 2022
Sponsor
Ahmed Salah Ahmed Abd Elgalil
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1. Study Identification

Unique Protocol Identification Number
NCT05069844
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 25, 2022 (Actual)
Study Completion Date
October 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Salah Ahmed Abd Elgalil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gum Chewing, Sore Throat, Endotracheal Intubation, Randomized Controlled Trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gum chewing for 2 minutes
Arm Type
Experimental
Arm Description
Patients will chew 1 piece of herbal sugar-free for 2 minutes and then spat it out.
Arm Title
Gum chewing for 4 minutes
Arm Type
Experimental
Arm Description
Patients will chew 1 piece of herbal sugar-free for 4 minutes and then spat it out.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients will be asked to swallow 2 times only.
Intervention Type
Dietary Supplement
Intervention Name(s)
Gum chewing for 2 minutes
Intervention Description
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
Intervention Name(s)
Gum chewing for 4 minutes
Intervention Description
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.
Primary Outcome Measure Information:
Title
The incidence of moderate/severe postoperative sore throat (POST) within 24 hours after surgery POST within 24 hours after surgery
Description
The incidence of moderate/severe POST within 24 hours after surgery
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Postoperative sore throat (POST) numeric rating scale (NRS) scores 2, 6, and 24 hours after surgery
Description
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.
Time Frame
24 hours Postoperative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Age 21-65 years Females American Society of Anesthesiologists (ASA) physical I-II Scheduled for elective breast surgery Under general anesthesia. Exclusion Criteria: Chronic laryngitis Chronic bronchitis Asthma Gastroesophageal reflux Allergies to study drugs Recent use of nonsteroidal anti-inflammatory drugs (NSAIDs) A history of upper respiratory tract infection Smoking and steroid therapy in the past week Failure to communicate normally Mallampati grade >2
Facility Information:
Facility Name
National Cancer Institute - Egypt
City
Cairo
ZIP/Postal Code
11561
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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