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This prospective, double-blind, randomized clinical trial aims to investigate the development of airway edema associated with intra-abdominal pressure during laparoscopic cholecystectomy. A total of 66 adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia will be randomly assigned into two equal groups (33 patients per group) based on intra-abdominal pressure levels: low-pressure and standard-pressure pneumoperitoneum. Ultrasonographic measurements will be used to assess airway soft tissue thickness at predefined time points before and after the pneumoperitoneum. The primary objective is to determine whether increased intra-abdominal pressure contributes to postoperative airway edema, which may pose a risk during extubation.
Airway edema can lead to difficult extubation and perioperative complications. Pneumoperitoneum during laparoscopic surgery increases intra-abdominal pressure (IAP), which may contribute to airway soft tissue edema due to cephalad fluid shifts and venous congestion. This prospective, randomized, double-blind study aims to assess whether different levels of IAP have a measurable effect on airway soft tissue thickness.
Patients aged 18 to 65 years, classified as ASA I-II, and scheduled for elective laparoscopic cholecystectomy will be included in the study. Upon arrival in the operating room, standard monitoring will be applied, anesthesia will be induced using intravenous sedation, and endotracheal intubation will be performed.
In the preoperative period, airway ultrasonography will be used to measure tongue thickness, midsagittal tongue cross-sectional area, tongue width, lateral pharyngeal wall thickness, parapharyngeal area thickness, and submental area thickness.
Patients will be randomly assigned into two groups:
Group 1: Patients receiving 10 mmHg intra-abdominal pressure Group 2: Patients receiving 14 mmHg intra-abdominal pressure
T0: Before intubation
T1: After intubation
T2: 30 minutes after the initiation of pneumoperitoneum
T3: 5 minutes after extubation
T4: 1 hour after extubation
T5: 2 hours after extubation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 mmHg Pneumoperitoneum | Active Comparator | Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 10 mmHg. |
|
| 14 mmHg Pneumoperitoneum | Active Comparator | Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 14 mmHg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10 mmHg Pneumoperitoneum | Diagnostic Test | Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 10 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lateral Pharyngeal Wall Thickness Measured by Airway Ultrasound | To compare the effect of two different pneumoperitoneum pressures (10 mmHg vs. 14 mmHg) on upper airway edema during laparoscopic cholecystectomy. The degree of airway edema will be assessed by measuring changes in lateral pharyngeal wall thickness using ultrasound before and after the procedure. | T0: Before intubation T1: After intubation T2: 30 minutes after the initiation of pneumoperitoneum T3: 5 minutes after extubation T4: 1 hour after extubation T5: 2 hours after extubation |
| Measure | Description | Time Frame |
|---|---|---|
| ultrasonographic airway parameter -tongue width | To compare the effect of two different pneumoperitoneum pressures (10 mmHg vs. 14 mmHg) on upper airway edema during laparoscopic cholecystectomy. The degree of edema will be evaluated by changes in ultrasonographic measurements of upper airway structures (e.g., tongue thickness, midsagittal cross-sectional area, pharyngeal wall thickness) before and after the procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences Kocaeli City Hospital | Kocaeli | Izmit | 41100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37782166 | Background | Aytac BG, Soyal OB. Ultrasonographic evaluation of the postoperative airway edema after robotic prostatectomy: a single center observational study. Eur Rev Med Pharmacol Sci. 2023 Sep;27(18):8505-8513. doi: 10.26355/eurrev_202309_33775. | |
| 41942843 | Derived | Cetin E, Gunel B, Yilmaz M, Civraz AZT, Hosgoz MT. Effects of different pneumoperitoneum pressures on the upper airway assessed by ultrasonography: a prospective, randomized, observer-blinded clinical study. BMC Anesthesiol. 2026 Apr 6;26(1):303. doi: 10.1186/s12871-026-03801-3. |
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| ID | Term |
|---|---|
| D011027 | Pneumoperitoneum |
| ID | Term |
|---|---|
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
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Parallel Assignment
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| 14 mmHg Pneumoperitoneum | Diagnostic Test | Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 14 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed. |
|
| T0: Before intubation T1: After intubation T2: 30 minutes after the initiation of pneumoperitoneum T3: 5 minutes after extubation T4: 1 hour after extubation T5: 2 hours after extubation |
| ultrasonographic airway parameter -tongue volume | To compare the effect of two different pneumoperitoneum pressures (10 mmHg vs. 14 mmHg) on upper airway edema during laparoscopic cholecystectomy. The degree of edema will be evaluated by changes in ultrasonographic measurements of upper airway structures (e.g., tongue thickness, midsagittal cross-sectional area, pharyngeal wall thickness) before and after the procedure. | T0: Before intubation T1: After intubation T2: 30 minutes after the initiation of pneumoperitoneum T3: 5 minutes after extubation T4: 1 hour after extubation T5: 2 hours after extubation |
| ultrasonographic airway parameter-pharyngeal thickness | To compare the effect of two different pneumoperitoneum pressures (10 mmHg vs. 14 mmHg) on upper airway edema during laparoscopic cholecystectomy. The degree of edema will be evaluated by changes in ultrasonographic measurements of upper airway structures (e.g., tongue thickness, midsagittal cross-sectional area, pharyngeal wall thickness) before and after the procedure. | T0: Before intubation T1: After intubation T2: 30 minutes after the initiation of pneumoperitoneum T3: 5 minutes after extubation T4: 1 hour after extubation T5: 2 hours after extubation |
| ultrasonographic airway parameter- neck circumference | To compare the effect of two different pneumoperitoneum pressures (10 mmHg vs. 14 mmHg) on upper airway edema during laparoscopic cholecystectomy. The degree of edema will be evaluated by changes in ultrasonographic measurements of upper airway structures (e.g., tongue thickness, midsagittal cross-sectional area, pharyngeal wall thickness) before and after the procedure. | T0: Before intubation T1: After intubation T2: 30 minutes after the initiation of pneumoperitoneum T3: 5 minutes after extubation T4: 1 hour after extubation T5: 2 hours after extubation |
| oxygen saturation changes | To evaluate the clinical impact of pneumoperitoneum pressure (10 mmHg vs. 14 mmHg) on postoperative airway outcomes. Clinical indicators such as oxygen saturation changes, signs of airway obstruction, hoarseness, sore throat, hypoxia, stridor, and re-intubation will be recorded. The incidence of these complications will be compared between groups to assess whether higher pressure is associated with increased airway-related morbidity. | Immediately after extubation and during early recovery (within the first 2 hours postoperative) |
| hoarseness | To evaluate the clinical impact of pneumoperitoneum pressure (10 mmHg vs. 14 mmHg) on postoperative airway outcomes. Clinical indicators such as oxygen saturation changes, signs of airway obstruction, hoarseness, sore throat, hypoxia, stridor, and re-intubation will be recorded. The incidence of these complications will be compared between groups to assess whether higher pressure is associated with increased airway-related morbidity. | Immediately after extubation and during early recovery (within the first 2 hours postoperative) |
| stridor | To evaluate the clinical impact of pneumoperitoneum pressure (10 mmHg vs. 14 mmHg) on postoperative airway outcomes. Clinical indicators such as oxygen saturation changes, signs of airway obstruction, hoarseness, sore throat, hypoxia, stridor, and re-intubation will be recorded. The incidence of these complications will be compared between groups to assess whether higher pressure is associated with increased airway-related morbidity. | Immediately after extubation and during early recovery (within the first 2 hours postoperative) |
| re-intubation | To evaluate the clinical impact of pneumoperitoneum pressure (10 mmHg vs. 14 mmHg) on postoperative airway outcomes. Clinical indicators such as oxygen saturation changes, signs of airway obstruction, hoarseness, sore throat, hypoxia, stridor, and re-intubation will be recorded. The incidence of these complications will be compared between groups to assess whether higher pressure is associated with increased airway-related morbidity. | Immediately after extubation and during early recovery (within the first 2 hours postoperative) |
| sore throat | To evaluate the clinical impact of pneumoperitoneum pressure (10 mmHg vs. 14 mmHg) on postoperative airway outcomes. Clinical indicators such as oxygen saturation changes, signs of airway obstruction, hoarseness, sore throat, hypoxia, stridor, and re-intubation will be recorded. The incidence of these complications will be compared between groups to assess whether higher pressure is associated with increased airway-related morbidity. | Immediately after extubation and during early recovery (within the first 2 hours postoperative) |
| Correlation Between Intravenous Fluid Volume and Airway Edema | To evaluate the correlation between the total intravenous fluid volume administered intraoperatively and the degree of airway edema, as measured by changes in ultrasonographic airway parameters (e.g., tongue thickness, pharyngeal wall thickness) at defined time points. | T0: Before intubation T1: After intubation T2: 30 minutes after the initiation of pneumoperitoneum T3: 5 minutes after extubation T4: 1 hour after extubation T5: 2 hours after extubation |