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Status unknownNCT02237716Updated Sep 11, 2014

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

An observational study in Craniotomy, sponsored by First Affiliated Hospital, Sun Yat-Sen University. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-09-11.

Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Observational

The sponsor has not verified this record recently (last verified Sep 2014), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
90
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Craniotomy
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In context

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 155 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

scheduled for elective craniotomy

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

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. cardiac index

    Time frame: during the procedure

  2. stroke volume index

    Time frame: during the procedure

  3. stroke volume variation

    Time frame: during the procedure

  4. systolic pressure

    Time frame: during the procedure

  5. central venous pressure

    Time frame: during the procedure

  6. heart rate

    Time frame: during the procedure

  7. peripheral vascular resistance

    Time frame: during the procedure

Secondary outcomes

  1. base excess

    Time frame: during the procedure

  2. lactic acid

    Time frame: during the procedure

  3. DO2I

    Time frame: during the procedure

07

Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02237716
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
Responsible party
Xinxin Shao (Resident, First Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
Sep 11, 2014
Start date
Jun 2014
Primary completion
Dec 2014 (estimated)
Completion
Jan 2015 (estimated)
Last update
Sep 11, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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