Investigating the impact of pharyngeal packing on gastric fluid volume after nasal surgery
The Effects of Pharyngeal Packing on the Postoperative Gastric Fluid Volume Measured by Ultrasound in Patients Undergoing Functional Endoscopic Nasal Surgery, a Randomized Controlled Double-blinded Non-inferiority Trial
This study is testing if using pharyngeal packing during nasal surgery affects the amount of fluid in the stomach for patients undergoing the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Kasr El Aini Hospital Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06957275 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate how pharyngeal packing affects gastric fluid volume in patients undergoing functional endoscopic nasal surgery (FESS). Patients will be randomly assigned to either receive pharyngeal packing or not, and their gastric volume will be assessed using ultrasound before the surgery. The study will follow strict fasting guidelines and utilize a standardized ultrasound technique to ensure accurate measurements. The findings could provide insights into optimizing perioperative care for patients undergoing nasal surgery.
Who should consider this trial
Good fit: Ideal candidates are adult patients over 18 years old, classified as ASA physical status I-II, scheduled for elective FESS under general anesthesia.
Not a fit: Patients with conditions that increase the risk of aspiration, such as GERD or a BMI over 35, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance postoperative care by reducing the risk of aspiration and improving patient outcomes.
How similar studies have performed: While similar studies have explored gastric volume management, this specific approach using pharyngeal packing in the context of FESS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants will be adult patients (above 18 years), with American Society of Anesthesiologists physical status I-II, scheduled for elective FESS under general anesthesia. Exclusion Criteria: * Patients at risk of aspiration (patients with lower esophageal disease such as Hiatus hernia, or GERD and DM). * Pregnancy. * Body mass index (BMI) greater than 35 kg/m2. * Refusal of the patient.
Where this trial is running
Cairo
- Cairo university hospitals, kasralainy — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Khaled Sarhan, MD — Cairo University Hospitals
- Study coordinator: Khaled Sarhan, MD
- Email: khaled.sarhan@kasralainy.edu.eg
- Phone: +201020067816
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.