Comparison of Effects of PEEP Levels on Respiratory Mechanics in Patients Undergoing Laparoscopic Cholecystectomy

Completed

• Conditions: Respiratory System Abnormalities

• Registration Number: NCT02439801
• Lead Sponsor: Umraniye Education and Research Hospital

Brief Summary

Laparoscopic cholecystectomy is accepted as gold standard in the management of cholelithiasis. Although laparoscopic procedures have many advantages,intra-abdominal CO2 insufflation can cause decreased lung volumes and compliance, increased airway resistance and impaired ventilation-perfusion ratio. In this study, investigators aim to investigate effects of intra-operative PEEP treatment at 3 distinct levels on respiratory dynamics and elimination time of volatile anesthetic agent.

Detailed Description

In the study, 75 ASA I-II patients aged 30-65 years will be randomized into 3 groups to receive 0 cmH2O PEEP (Group-1), 5 cmH2O PEEP (Group-2) and 8 cmH2O PEEP (Group-3) in PVC mode. In all patients underwent general anesthesia; hemodynamic parameters, Ppeak, Pplateau, compliance values as well as Fisevo/Fexpsevo ratio at 1 MAC and times from 1 MAC to 0.3 and 0.1 MAC will be recorded. In addition, preoperative and postoperative pulmonary function tests will be compared in all patients.

Study Timeline

• Study Start: 2015-03
• Status Verified: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Study First Submitted: 2015-05-03
• Study First Submitted QC: 2015-05-06
• Last Update Submitted: 2015-05-06
• Study First Posted: 2015-05-12
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• ASA (American Society of Anesthesiologists) I-II
• BMI of 25-30
• patients scheduled to elective laparoscopic cholecystectomy.

Exclusion Criteria

• Patients with ASA III, IV, V risk,
• Patients with comorbid diseases that may increase intra-abdominal pressure or pulmonary hypertension,
• Patients with renal and hepatic failure,
• Patients with pregnancy and
• Patients using bronchodilator or steroid were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
levels of static-dynamic compliance with intra-operative PEEP treatment at 3 distinct levels	1 month

Secondary Outcome Measures

Name	Time	Method
levels of p peak and p plateau pressures with intra-operative PEEP treatment at 3 distinct levels	1 month
elimination time of volatile anesthetic agent with intra-operative PEEP treatment at 3 distinct levels	1 month

Trial Locations

Locations (1)

Istanbul Umraniye Training Hospital; 🇹🇷 Istanbul, Turkey