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Rapid Intravenous Infusion of Mannitol Results in a Dipper-type Change in Stroke Volume Variation in Patients Undergoing Major Neurosurgery

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02237716
Enrollment
90
Registered
2014-09-11
Start date
2014-06-30
Completion date
2015-01-31
Last updated
2014-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniotomy

Brief 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.

Interventions

None listed

Sponsors

First Affiliated Hospital, Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
peripheral vascular resistanceduring the procedure
systolic pressureduring the procedure
central venous pressureduring the procedure
heart rateduring the procedure
cardiac indexduring the procedure
stroke volume indexduring the procedure
stroke volume variationduring the procedure

Secondary

MeasureTime frame
lactic acidduring the procedure
DO2Iduring the procedure
base excessduring the procedure

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026