CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
Sevoflurane +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02188407
NCT02188407Phase 1Completed

Phase 1 Study of Antiinflammatory Effect of Sevoflurane in Open Lung Surgery With One-Lung Ventilation

University Medical Centre Ljubljana·interventional·Posted Jul 11, 2014·Updated Jul 11, 2014

In Brief

A Phase 1 clinical trial evaluating Sevoflurane and Propofol for Inflammation. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The aim of the study was to prospectively investigate the influence of one-lung ventilation (OLV) on the inflammatory response and to identify possible antiinflammatory effects of the volatile anaesthetic sevoflurane. Forty patients undergoing thoracic surgery with OLV were enrolled in this prospective, randomised study. The patients were randomly allocated into two groups to receive either propofol (Group P) or sevoflurane (Group S) for induction and maintenance of anaesthesia. Inflammatory mediators (Interleukin 6 (IL6), Interleukin8 (IL8), Interleukin 10 (IL10), (C- reactive protein)CRP) were measured intra- and postoperatively. Six hours after surgery oxygenation index (PaO2/FiO2) was calculated and chest X ray was taken and assessed. The clinical outcome determinated by postoperative adverse events was assessed as the secondary endpoint.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInflammation
CountriesSlovenia
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 11, 2014
Enrollment StartJul 1, 2008
Primary CompletionSep 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 12.0 years ago

Interventions

Sevofluranedrug

MAC 3-5 V% during surgery

Propofoldrug

Propofol group (P group)- The group anaesthesied with propofol