Ultrasonographic Assessment of Airway Edema Induced by Intra-abdominal Pressure During Laparoscopic Cholecystectomy: A Prospective, Double-Blind, Randomized Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• Age between 18 and 65 years

• ASA physical status I-II

• Body mass index (BMI) \< 30 kg/m²

• Mallampati score I-II

• Scheduled for elective laparoscopic cholecystectomy

Locations
Other Locations
Turkey
University of Health Sciences Kocaeli City Hospital
RECRUITING
Kocaeli
Contact Information
Primary
ENGİN ÇETİN
doccetin52@gmail.com
0 532 120 60 04
Time Frame
Start Date: 2025-06-18
Estimated Completion Date: 2025-11-13
Participants
Target number of participants: 66
Treatments
Active_comparator: 10 mmHg Pneumoperitoneum
Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 10 mmHg.
Active_comparator: 14 mmHg Pneumoperitoneum
Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 14 mmHg.
Related Therapeutic Areas
Sponsors
Leads: Engin Çetin

This content was sourced from clinicaltrials.gov