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.
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
- Conditions the study is for
- Transanal Endoscopic Surgical Procedures, Residual Volume, Gastric
- 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.
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 group | Role | What they receive |
|---|---|---|
| non packing group (c) | Experimental | will include the patients who will not receive pharyngeal packing Receives: Procedure: Nasal packing |
| packing group (P) | Active comparator | will 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.
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)
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
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
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
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.
- First posted4 May 2025
- Study start26 Apr 2025
- Primary completion7 Aug 2025
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transanal Endoscopic Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital
- Investigators
- Khaled Sarhan, MD, Principal investigator, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06957275
- Acronym / sponsor ID
- MD-420-2023
- Keywords
- Ultrasound, Gastric residual volume, Endoscopic sinus surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 26 Apr 2025 (actual)
- Primary completion
- 7 Aug 2025 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| non packing group (c) | Experimental | Procedure: Nasal packingwill include the patients who will not receive pharyngeal packing |
| packing group (P) | Active comparator | Procedure: Nasal packingwill include the patients who will receive pharyngeal packing |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants will be adult patients (above 18 years), with American Society of Anesthesiologists physical status I-II, scheduled for elective FESS under general anesthesia.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal packinggroup c will not receive pharyngeal packing | Procedure or surgery | packing group (P) |
| Nasal packingGroup (P): will include the patients who will receive pharyngeal packing | Procedure or surgery | non packing group (c) |
Primary outcome
The primary outcome of the current study is Gastric residual volume at the end of the procedure.
Time frame: 4 hours
The primary outcome of the current study is Gastric residual volume at the end of the procedure.
4 secondary outcomes
Quantitative assessment of the risk of aspiration
Time frame: 6 hours
Post operative nausea and vomiting incidence at PACU
Time frame: 6 hours
Lung ultrasound Score
Time frame: 6 hours
Throat pain at Post anesthesia care unit
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaled Sarhan, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
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.