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

Sponsor
First Affiliated Hospital, Sun Yat-Sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02237716
Collaborator
(none)
90
Enrollment
7
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Study Start Date :
    Jun 1, 2014
    Anticipated Primary Completion Date :
    Dec 1, 2014
    Anticipated Study Completion Date :
    Jan 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. cardiac index [during the procedure]

    2. stroke volume index [during the procedure]

    3. stroke volume variation [during the procedure]

    4. systolic pressure [during the procedure]

    5. central venous pressure [during the procedure]

    6. heart rate [during the procedure]

    7. peripheral vascular resistance [during the procedure]

    Secondary Outcome Measures

    1. base excess [during the procedure]

    2. lactic acid [during the procedure]

    3. DO2I [during the procedure]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • First Affiliated Hospital, Sun Yat-Sen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xinxin Shao, Resident, First Affiliated Hospital, Sun Yat-Sen University
    ClinicalTrials.gov Identifier:
    NCT02237716
    Other Study ID Numbers:
    • MN2014
    First Posted:
    Sep 11, 2014
    Last Update Posted:
    Sep 11, 2014
    Last Verified:
    Sep 1, 2014

    Study Results

    No Results Posted as of Sep 11, 2014