The Effects of Pharyngeal Packing on the Postoperative Gastric Fluid Volume in Patients Undergoing Functional Endoscopic Nasal Surgery

NCT06957275 | Completed

• 1 other identifier: MD-420-2023
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the aim is to investigate the effects of Pharyngeal Packing on the perioperative gastric volume in patients undergoing FESS, by ultrasound assessment

Conditions

Transanal Endoscopic Surgical Procedures; Residual Volume; Gastric; Ultrasound

Keywords

Ultrasound; Gastric residual volume; Endoscopic sinus surgery

Outcome Measures

Primary Outcomes (1)

• The primary outcome of the current study is Gastric residual volume at the end of the procedure.

  The primary outcome of the current study is Gastric residual volume at the end of the procedure.

  4 hours

Secondary Outcomes (4)

• Quantitative assessment of the risk of aspiration

  6 hours

• Post operative nausea and vomiting incidence at PACU

  6 hours

• Lung ultrasound Score

  6 hours

• Throat pain at Post anesthesia care unit

  6 hours

Study Arms (2)

non packing group (c)

EXPERIMENTAL

will include the patients who will not receive pharyngeal packing

Procedure: Nasal packing

packing group (P)

ACTIVE COMPARATOR

will include the patients who will receive pharyngeal packing

Procedure: Nasal packing

Interventions

Nasal packing PROCEDURE

group c will not receive pharyngeal packing

packing group (P)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants will be adult patients (above 18 years), with American Society of Anesthesiologists physical status I-II, scheduled for elective FESS under general anesthesia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo university hospitals, kasralainy

Cairo, 11559, Egypt

Location

Study Officials

• Khaled Sarhan, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, Asst. professor of anesthesia, Cairo university

Model Details: In this study, patients undergoing Nasal surgery will be randomized into 2 groups. * Group (P): will include the patients who will receive pharyngeal packing * Group (C): will include the patients who will not receive pharyngeal packing

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 4, 2025
• Study Start: April 26, 2025
• Primary Completion: August 7, 2025
• Study Completion: August 7, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)