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Clinical Trials/NCT02439801
NCT02439801CompletedNot Applicable

Comparison of Effects of 3 Different PEEP Levels on Hemodynamic, Respiratory Mechanics and Elimination of Volatile Anesthetic Agent in Patients Undergoing Laparoscopic Cholecystectomy

Umraniye Education and Research Hospital1 site in 1 country75 target enrollmentStarted: March 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
75
Locations
1
Primary Endpoint
levels of static-dynamic compliance with intra-operative PEEP treatment at 3 distinct levels

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Crossover
Time Perspective
Prospective

Eligibility Criteria

Ages
30 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

levels of static-dynamic compliance with intra-operative PEEP treatment at 3 distinct levels

Time Frame: 1 month

Secondary Outcomes

  • 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)

Investigators

Sponsor
Umraniye Education and Research Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Gulsah Karaoren

MD

Umraniye Education and Research Hospital

Study Sites (1)

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