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

Craniotomy Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02237716
• Other study ID #: MN2014
• Status: Active, not recruiting
• Phase: N/A
• First received: August 26, 2014
• Last updated: September 10, 2014
• Start date: June 2014
• Est. completion date: January 2015

Study information

• Verified date: September 2014
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Craniotomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac index		during the procedure	Yes
Primary	stroke volume index		during the procedure	Yes
Primary	stroke volume variation		during the procedure	Yes
Primary	systolic pressure		during the procedure	Yes
Primary	central venous pressure		during the procedure	Yes
Primary	heart rate		during the procedure	Yes
Primary	peripheral vascular resistance		during the procedure	Yes
Secondary	base excess		during the procedure	Yes
Secondary	lactic acid		during the procedure	Yes
Secondary	DO2I		during the procedure	Yes