Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05069844 |
| Other study ID # |
AP2106-50108 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2021 |
| Est. completion date |
October 26, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
National Cancer Institute, Egypt |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
