Using Gengigel to Moisten Throat Packs in Surgery

The Pilot Study of Throat Packs Soaked in Gengigel Spray in Patients Undergoing Elective Surgery Under General Anaesthesia

This study is testing if using Gengigel spray to moisten throat packs during surgery can help reduce throat pain and improve recovery for patients aged 18 to 60.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: University of Malaya (Academic / other)
• Locations: 1 site (Kuala Lumpur)
• Trial ID: NCT06947161 on ClinicalTrials.gov

What this trial studies

This pilot study investigates the use of Gengigel spray, a hyaluronic acid-based product, to moisten throat packs during elective surgeries involving the oral cavity and pharynx. Traditional throat packs are typically moistened with saline, but this study aims to explore the potential benefits of Gengigel, which is known for its healing and anti-inflammatory properties. By using Gengigel, the study seeks to reduce postoperative throat pain and discomfort, thereby improving recovery and patient satisfaction. The study includes patients classified as ASA I-II, aged 18 to 60, and excludes those with pre-existing sore throats or difficult airway concerns.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 classified as ASA I-II who are undergoing elective surgery involving the oral cavity.

Not a fit: Patients with pre-existing sore throats or those anticipated to have difficult airways may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce postoperative throat pain and enhance recovery for patients undergoing surgery.

How similar studies have performed: While Gengigel has been used in other medical applications, this specific approach to moistening throat packs is novel and has not been previously tested.

Eligibility criteria

Inclusion Criteria:

1. Classified as ASA I-II, indicating a relatively low risk of complications from anesthesia
2. Aged between 18 and 60 years, which represents a typical adult surgical population
3. Both male and female patients, ensuring gender inclusivity and representation in the study findings

Exclusion Criteria:

1. Existing sore throat prior to surgery, which could affect the baseline measurement of postoperative sore throat.
2. Anticipation of a difficult airway, as these patients may require specialized intubation techniques that are not standardized across the study.
3. More than two attempts at endotracheal tube (ETT) insertion, as multiple attempts could cause additional trauma and skew the study outcomes.
4. Any trauma occurring during intubation, which could independently contribute to postoperative sore throat and other complications

Where this trial is running

Kuala Lumpur

• Sabreena Ismail — Kuala Lumpur, Malaysia (Recruiting)

Study contacts

• Study coordinator: sabreena ismail, MD

Conditions Throat, Sore