Cairo university hospitals, kasralainy
Cairo, 11559, Egypt
NCT Number: NCT06957275
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
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Cairo, 11559, Egypt
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.
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)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
group c will not receive pharyngeal packing
Time frame: 4 hours
The primary outcome of the current study is Gastric residual volume at the end of the procedure.
Time frame: 6 hours
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.
Time frame: 6 hours
Post operative nausea and vomiting incidence will be assessed at 5-time points using PONV score
Time frame: 6 hours
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
Time frame: 6 hours
Throat pain will be assessed using VAS
Kasr El Aini Hospital
Other
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
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