Overview

This trial is active, not recruiting.

Condition craniotomy
Sponsor First Affiliated Hospital, Sun Yat-Sen University
Start date June 2014
End date December 2014
Trial size 90 participants
Trial identifier NCT02237716, MN2014

Summary

The purpose of this study is to observe the variation of Hemodynamics、lactic acid、base excess、peripheral vascular resistance and DO2 through FloTrac™/Vigileo™ system after rapid infusion mannitol in neurosurgery.The hemodynamic changes after mannitol infusion are shown in Figure 1. HR (Fig. 1A) and systolic BP (Figure 1B) significantly increased between 0 min and 10 min (P = 0.041) and between -10 min and 10 min (P = 0.073), respectively; these two variables decreased steadily and returned to the baseline. Diastolic BP (Fig. 1B) showed no significant change after mannitol infusion (P = 0.102). CVP (Fig. 1C) significantly increased between -20 min and 0 min (P < 0.001) and constantly decreased after 0 min, which remained below the baseline between 30 min and 60 min. CI (Fig. 1D) and SVI (Fig. 1E) showed a significant persistent increase between -20 min to 0 min (P < 0.001) and between -20 min and 10 min (P < 0.001), respectively. SVV exhibited a dipper-type change shown as a significant decrease between -20 min and 0 min and a significant increase between 0 min and 60 min (P < 0.001), which returned to the baseline after 20 min.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Primary Outcomes

Measure
cardiac index
time frame: during the procedure
stroke volume index
time frame: during the procedure
stroke volume variation
time frame: during the procedure
systolic pressure
time frame: during the procedure
central venous pressure
time frame: during the procedure
heart rate
time frame: during the procedure
peripheral vascular resistance
time frame: during the procedure

Secondary Outcomes

Measure
base excess
time frame: during the procedure
lactic acid
time frame: during the procedure
DO2I
time frame: during the procedure

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - The inclusion criteria were: being aged between 16 and 70 years; - with a body mass index of 18-25 kg/m2; - with a physical status classified as ASA class I or II; - and scheduled for elective craniotomy Exclusion Criteria: - Any patient would be excluded from this study if the patient had complicating serious coagulopathy, hepatorenal insufficiency, aortic regurgitation, or cardiac arrhythmia; - had a previous history of intra-aortic balloon counterpulsation; - exhibited systolic blood pressure (SBP) ≥160 mmHg, diastolic blood pressure (DBP) ≥100 mmHg, or heart rate ≥ 100 bpm on operating room admission; - or rejected to participate in this study.

Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by First Affiliated Hospital, Sun Yat-Sen University.