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

NCT02237716 | Unknown

• 1 other identifier: MN2014
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Craniotomy

Outcome Measures

Primary Outcomes (7)

• cardiac index

  during the procedure

• stroke volume index

  during the procedure

• stroke volume variation

  during the procedure

• systolic pressure

  during the procedure

• central venous pressure

  during the procedure

• heart rate

  during the procedure

• peripheral vascular resistance

  during the procedure

Secondary Outcomes (3)

• base excess

  during the procedure

• lactic acid

  during the procedure

• DO2I

  during the procedure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

scheduled for elective craniotomy

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: September 11, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: September 11, 2014

Record last verified: 2014-09