About this trial
Throat packs are commonly used in many surgical procedures involving the oral cavity and pharynx, primarily to prevent blood, saliva, and other debris from entering the lower respiratory tract, thereby maintaining a clear airway and reducing the risk of aspiration and respiratory complications. Traditionally, these packs are moistened with saline or used in a dry state, with the choice often depending on the surgeon's preference and specific surgical requirements. However, despite their widespread usage, the exploration of alternative substances to moisten throat packs, particularly those with additional therapeutic benefits, remains limited in medical research. This pilot study introduces Gengigel spray as an innovative alternative to saline for moistening throat packs. Gengigel, a hyaluronic acid (HA)-based product, is known for its healing properties and anti-inflammatory effects, which are beneficial in oral care. Gengigel provides a non-anesthetic approach that promotes tissue repair and reduces inflammation. This makes it particularly advantageous in the context of surgical procedures where reducing postoperative inflammation and promoting mucosal healing are crucial.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Classified as ASA I-II, indicating a relatively low risk of complications from anesthesia
Aged between 18 and 60 years, which represents a typical adult surgical population
Both male and female patients, ensuring gender inclusivity and representation in the study findings
Disqualifiers
Existing sore throat prior to surgery, which could affect the baseline measurement of postoperative sore throat.
Anticipation of a difficult airway, as these patients may require specialized intubation techniques that are not standardized across the study.
More than two attempts at endotracheal tube (ETT) insertion, as multiple attempts could cause additional trauma and skew the study outcomes.
Any trauma occurring during intubation, which could independently contribute to postoperative sore throat and other complications
Trial design
Parallel
Treatments tested in this trial
Gengigel
DrugThroat pack will be soaked with gengigel, and post operatively, will see if there is any presence of sore throat, severity of sore throat. 10 mlm of gengigel, in liquid form will be used to soak the throat pack. 30 patients will receive gengigel spray soaked throat pack, and control group will receive normal saline soaked throat pack
Treatment groups
Trial outcomes
Primary outcomes
Incidence of postoperative sore throat.
This will be assessed with Scoring System of Harding and McVey
Secondary outcomes
Severity of postoperative sore throat
This will be assessed with Scoring System of Harding and McVey
Patient satisfaction
This will be assessed with a yes/no question regarding their overall satisfaction with the postoperative care.
The presence of hoarseness of voice
This will be assessed with Scoring System of Harding and McVey
The presence of cough
This will be assessed with Scoring System of Harding and McVey
Sponsors and contacts
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