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Ultrasound Assessment of Airway Edema During Laparoscopic Cholecystectomy

NCT07021482 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-11-18

No results posted yet for this study

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.

Conditions

  • Airway Edema
  • Perioperative Complication
  • Pneumoperitoneum

Interventions

DIAGNOSTIC_TEST

10 mmHg Pneumoperitoneum

Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 10 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.

DIAGNOSTIC_TEST

14 mmHg Pneumoperitoneum

Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 14 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.

Sponsors & Collaborators

  • Engin Çetin

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-18
Primary Completion
2025-09-17
Completion
2025-09-17

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07021482 on ClinicalTrials.gov