CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 25 enrolled
Drug / intervention
Propofol +1 moredrug
Likely dose
Propofol 4 mcgfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02203097
NCT02203097Phase 4Completed

The Effect of Different End-tidal Carbon-dioxide Levels on Cerebral CO2 Vasoreactivity and the Stiffness of Systemic Arteries During Propofol Anesthesia

University of Debrecen·interventional·Posted Jul 29, 2014·Updated Mar 9, 2017

In Brief

A Phase 4 clinical trial evaluating Partial pressure of CO2 at the end of an exhaled breath and Propofol for Propofol-anaesthesia Via Target-controlled Infusion. Completed, enrolled 25 participants across 1 site.

Detailed Summary

Purpose: The purpose of this study is to examine the effect of different carbon-dioxide concentrations on cerebral CO2 sensitivity and the resistance and stiffness of systemic arteries during anesthesia with target-controlled infusion anesthesia using intravenous propofol. Propofol is a widely and commonly used intravenous anaesthetic, that is mainly used for the induction of general anesthesia and the maintenance of total intravenous anaesthesia (TIVA). Changes in the velocity of cerebral blood flow and arterial stiffness due to the different exhaled carbon-dioxide concentrations will allow us to conclude how propofol affects these parameters during the course of the narcosis. Instruments: An ultrasound device called transcranial doppler (TCD) is used to measure the velocity of blood flow within a main artery located inside the skull. A tonometry device named SphygmoCor is used to assess the pressure wave proceeding in the radial artery, from which the stiffness of the systemic vessels can be concluded. Measurements: \- Examinations with the ultrasound and tonometry devices are carried out once before the operation, three times during the intervention, with different exhaled CO2 values and once after the operation is completed. Hypothesis: \- Propofol alters cerebral carbon-dioxide sensitivity and the stiffness of systemic arteries during TCI anaesthesia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesHungary
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 29, 2014
Enrollment StartJan 1, 2014
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.9 years ago

Interventions

Partial pressure of CO2 at the end of an exhaled breathprocedure

Three previously defined EtCO2 levels (partial pressure of CO2 at the end of an exhaled breath) were adjusted during anesthesia.

Propofoldrug

Propofol is administered to all patients via target-controlled infusion (TCI) to reach 4 mcg/ml constant plasma concentration according to the Schneider model during the course of the narcosis.