Gum ChewingNCT05069844
Preoperative Gum Chewing for Different Durations to Prevent Sore Throat After Endotracheal Intubation
A study testing Gum chewing for 2 minutes and Gum chewing for 4 minutes in people with Gum Chewing and Sore Throat, run by Ahmed Salah Ahmed Abd Elgalil at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Gum Chewing, Sore Throat, Endotracheal Intubation
- What is being tested?
- Gum chewing for 2 minutes and Gum chewing for 4 minutes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 26 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Chronic laryngitis
- Chronic bronchitis
- Asthma
- Gastroesophageal reflux
- Allergies to study drugs
- Recent use of nonsteroidal anti-inflammatory drugs (NSAIDs)
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- A history of upper respiratory tract infection
- Smoking and steroid therapy in the past week
- Failure to communicate normally
- Mallampati grade >2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Gum chewing for 2 minutes, Gum chewing for 4 minutes
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gum chewing for 2 minutesDietary 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 minutesDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Gum chewing for 2 minutes | Experimental | Patients will chew 1 piece of herbal sugar-free for 2 minutes and then spat it out. Receives: Dietary Supplement: Gum chewing for 2 minutes |
| Gum chewing for 4 minutes | Experimental | Patients will chew 1 piece of herbal sugar-free for 4 minutes and then spat it out. Receives: Dietary Supplement: Gum chewing for 4 minutes |
| Control group | No intervention | Patients will be asked to swallow 2 times only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours postoperative
Secondary outcomes (1)
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.
Measured: 24 hours Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Oct 2021
- Primary completion25 Oct 2022
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gum ChewingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Salah Ahmed Abd Elgalil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Salah Ahmed Abd Elgalil, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069844
- Sponsor's protocol ID
- AP2106-50108
- Status last verified
- Nov 2022
- First submitted
- 25 Sep 2021
- Last updated
- 21 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Gum Chewing for Different Durations to Prevent Sore Throat After Endotracheal Intubation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05069844
- Acronym / sponsor ID
- AP2106-50108
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ahmed Salah Ahmed Abd ElgalilUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Gum chewing for 2 minutes | Experimental | Dietary Supplement: Gum chewing for 2 minutesPatients will chew 1 piece of herbal sugar-free for 2 minutes and then spat it out. |
| Gum chewing for 4 minutes | Experimental | Dietary Supplement: Gum chewing for 4 minutesPatients will chew 1 piece of herbal sugar-free for 4 minutes and then spat it out. |
| Control group | No intervention | –Patients will be asked to swallow 2 times only. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- Chronic laryngitis
- Chronic bronchitis
- Asthma
- Gastroesophageal reflux
- Allergies to study drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gum chewing for 2 minutesIn 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. | Dietary supplement | Gum chewing for 2 minutes |
| Gum chewing for 4 minutesIn 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. | Dietary supplement | Gum chewing for 4 minutes |
Primary outcome
The incidence of moderate/severe postoperative sore throat (POST) within 24 hours after surgery POST within 24 hours after surgery
Time frame: 24 hours postoperative
The incidence of moderate/severe POST within 24 hours after surgery
1 secondary outcome
Postoperative sore throat (POST) numeric rating scale (NRS) scores 2, 6, and 24 hours after surgery
Time frame: 24 hours Postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gum chewing for 2 minutes and Gum chewing for 4 minutes in people with Gum Chewing and Sore Throat, run by Ahmed Salah Ahmed Abd Elgalil at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of moderate/severe postoperative sore throat (POST) within 24 hours after surgery POST within 24 hours after surgery (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.