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Transanal Endoscopic Surgical ProceduresNCT06957275

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

A study testing Nasal packing in people with Transanal Endoscopic Surgical Procedures and Residual Volume, run by Kasr El Aini Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Nasal packing
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteEgypt
Study dates
26 Apr 2025to 7 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Cairo university hospitals, kasralainy

    Cairo, 11559

Other trials in Egypt

About this study

Official title: 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

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

Read the detailed description

Following approval from the Ethics and Research Committee of the anesthesia department, Faculty of Medicine, Cairo University, and obtaining written informed consent from all participating patients meeting the inclusion criteria; patients will be randomly assigned into two groups using a computer-generated random number list with a closed-sealed envelope.

  • Group (P): will include the patients who will receive pharyngeal packing
  • Group (C): will include the patients who will not receive pharyngeal packing The day before the operation, all patients should be instructed to follow institutional fasting guidelines (a minimum of 2 h for clear fluids, 6 h for a light meal, and 8 h for a meal that included fried or fatty food) On operation day,The patient will attend at the pre-anesthesia room 1 hour before the procedure. A 20 Gauge cannula will be inserted peripherally.

Prophylactic antiemetic (metoclopramide 0.15mg/ kg) will be given slowly intravenously as premedication.

Then a serial ultrasonographic qualitative and quantitative assessment of the gastric antrum of the patients will be done and recorded preoperatively by the anesthetist who will be blinded to the study groups.

A preoperative ultrasonographic examination of the gastric antrum (at the sagittal plane between the left lobe of the liver and pancreas at the level of the aorta) will be performed in the right lateral decubitus position

Ultrasound Assessments:

A standardized scanning technique will be used with a portable sonographic system equipped with a 5- to 2-MHz curved array transducer (GE HealthCare). Subjects will be first placed in the supine position and then in the right lateral decubitus (RLD) position, always in a 45°semirecumbent position. In both of these positions, fluid or semifluid content gravitates preferentially to the antrum, and air or gas is displaced proximally toward the body or fundus, thus facilitating antral sonography (8) During ultrasound imaging, the gastric antrum will be identified in the sagittal to right parasagittal plane using the left lobe of the liver, the pancreas, abdominal aorta, or inferior vena cava as anatomical landmarks. The ultrasonographic assessment will consist of a qualitative and quantitative evaluation of the gastric antrum. The qualitative assessment is aimed at the nature of gastric content (empty, fluid, or solid content). Based exclusively on this qualitative assessment of the antrum, and once the presence of solid content will be ruled out, patients will be classified into 3 grades (12)

  • Grade 0 antrum: is defined as the absence of fluid content in both supine and RLD positions, suggesting a "completely empty" state.
  • Grade 1 antrum: If fluid content is observed only in the RLD position, but not in the supine position. It correlates with low-volume states compatible with baseline gastric secretions in fasted patients.
  • Grade 2 antrum: If fluid is observed in both supine and RLD. The quantitative assessment of the gastric volume will be performed by measuring the cross-sectional area (CSA) of the gastric antrum (antral CSA) between peristaltic contractions, using the free-tracing calibre of the ultrasound unit. This free-tracing method is equivalent to the 2-diameter method of area measurement, and it is simpler and highly reproducible. This validated method allows rapid point-of-care assessment at the bedside, which is relevant for clinical practice (13) Using GE ultrasonography

Then gastric volume will be calculated using the following equation:

Volume (ml) = 27 + 14.6 x Right lateral CSA (cm2

) - 1.28 x age (year) Where Right-lat CSA is the antral CSA measured in the right lateral decubitus. In the operative room, standard monitoring (electrocardiography, pulse oximetry, non-invasive blood pressure, and capnography after intubation) will be applied to the patient.

General Anesthesia (GA) will be induced by another anesthetist who will open the closed envelope and not be blinded to the study groups with intravenous propofol 2 mg/kg, fentanyl 2 mcg/kg, atracurium 0.5 mg/kg, and the trachea will be intubated after mask ventilation for 3 minutes.

Anesthesia will be maintained with IPPV, isoflurane (MAC 1-1.5) in oxygen/air and atracurium 0.1mg/kg as a neuromuscular blocker by the time every 20 minutes. Ventilation will be controlled to maintain an end-tidal CO2 at 30 -35 mmHg.

Following the orotracheal intubation, soft wet pharyngeal packs were placed with gentle maneuvers to avoid damage to the soft palate in patients in group (P). The end of the pharyngeal pack will be hidden inside the mouth of the patient. Patients in both groups were intravenously administered ranitidine (0.5 mg/kg) following the intubation, and ketorolac (30 mg) and pethidine (0.5 mg/kg) at the end of the operation for postoperative analgesia.

Gastric ultrasonographic evaluation will be done at the end of the operation by the same anesthetist who will be blinded to the study group as described before, and the pharyngeal packs of the patients in group(P) will be removed, the residual neuromuscular block will be antagonized with atropine 0.01 m/kg and neostigmine 0.05mg/kg and extubation and suction under vision will be done.

Being tested
Nasal packing
Keywords
Ultrasound, Gastric residual volume, Endoscopic sinus surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nasal packingProcedure or surgery

    group c will not receive pharyngeal packing

  • Nasal packingProcedure or surgery

    Group (P): will include the patients who will receive pharyngeal packing

Study groups in NCT06957275
Study groupRoleWhat they receive
non packing group (c)Experimentalwill include the patients who will not receive pharyngeal packing
Receives: Procedure: Nasal packing
packing group (P)Active comparatorwill include the patients who will receive pharyngeal packing
Receives: Procedure: Nasal packing

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 hours

Secondary outcomes (4)
  1. Quantitative assessment of the risk of aspiration

    Quantitative assessment of the risk of aspiration will be done using three cut-off values for GFV; 1.5 mL/kg, 1.25 mL/kg, and 0.8 mL/kg.

    Measured: 6 hours

  2. Post operative nausea and vomiting incidence at PACU

    Post operative nausea and vomiting incidence will be assessed at 5-time points using PONV score

    Measured: 6 hours

  3. Lung ultrasound Score

    Lung ultrasound will be performed before induction of anesthesia and at the end of the operation and using the same curvilinear probe and will be assessed according to the lung ultrasound score

    Measured: 6 hours

  4. Throat pain at Post anesthesia care unit

    Throat pain will be assessed using VAS

    Measured: 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2025
  2. Study start26 Apr 2025
  3. Primary completion7 Aug 2025
  4. Study completion7 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06957275
Sponsor's protocol ID
MD-420-2023
Status last verified
Aug 2025
First submitted
26 Apr 2025
Last updated
11 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Nasal packing in people with Transanal Endoscopic Surgical Procedures and Residual Volume, run by Kasr El Aini Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome of the current study is Gastric residual volume at the end of the procedure. (time frame: 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.

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