Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482573
Status:
COMPLETED
Last Update Posted:
2008-06-05
First Post:
2007-06-04
Brief Title:
Dental Anesthesia in Pregnant Women With Rheumatic Heart Disease
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Maternal-Fetal Monitoring of Patients With Rheumatic Heart Disease During Dental Procedure Under Local Anesthesia
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The hemodynamic parameters of 31 pregnant women with rheumatic valve disease undergoing restorative dentistry under local anesthesia with 2 solution of lidocaine divided in two groups with Group LE and without 1100000 epinephrine solution Group LNE were studied by 24-hour ambulatory electrocardiographic monitoring intermittent blood pressure monitoring and continuous cardiotocography during three standard time periods A significant decrease in the values of maternal heart rate was seen during the procedure in comparison with the other two time periods in the two groups as well as the occurrence of cardiac arrhythmia in 9 291 patients being 7 418 of them in the group receiving epinephrine anesthesia We conclude the use of 2 lidocaine in association with epinephrine proved safe during dental procedure in pregnant women with rheumatic valve disease
Detailed Description:
During pregnancy the organic systems of a woman are subjected to physiological modifications consequential to hormonal anatomic and metabolical alterations The most significant modification in the circulatory system is an increased cardiac output from the first three months of gestation Women with heart disease may present with severe complications during the gestational period because of inappropriate adaptation of her body to this hemodynamic overload even those patients who are thought to have an appropriate functional capacity during early pregnancy There are scant studies in the literature on the effects of local anesthetics with and without vasoconstrictor used in dental procedures on the cardiovascular variables of pregnant women with valvar disease as well as on their concepti Driven by this shortage we decided to have this subject studied by assessing and analyzing cardiotocographic parameters such as fetal heart rate FHR fetal motilityFM and uterine contractions UC in addition to blood pressure BP and electrocardiographic variables such as heart rate HR and extrasystoles ES in pregnant women with rheumatic valvar disease who undergo local anesthesia with lidocaine with and without vasoconstrictor during restorative dental procedure For this 31 rheumatic heart disease patients who were in their 28th to 37th week of gestation had 24-hour ambulatory monitoring of their BP and Holter electrocardiography Holter-ECG and cardiotocography CTG performed during 1 baseline - 60 minutes before the procedure for BP and Holter-ECG monitoring and 20 minutes before the procedure for CTG 2 procedure - 56155 minutes meanSD 3 post-procedure - 20 minutes and 4 mean 24-hour HR and ES measurement and mean wake and sleeping periods BP monitoring Variation of the above variables was analyzed in two groups one with infusion of a 2 solution of lidocaine without vasoconstrictor Group LNE composed of 14 patients and the other with infusion of a 2 solution of lidocaine with epinephrine 1100000 Group LE composed of 17 patients randomized drawing and single blind The investigator wise person which solution of lidocaine was being used therefore the proper local vasoconstriction denounced if it was infiltrated or not epinephrine The used technique was of the modified periodontal ligament PDLm injection by means of the equipment The Wand infusing 18 ml one cartridge in six minutes We use the technique of analysis of variance ANOVA with repeated measures to calculate the size of the sample and for the analysis and multiple interpretation of the variable in three distinct periods on the basis of the table of Vonesh and Shork 15 patients in each group considering a correlation enters the measures of next value the 04 a level of significance of 5 and to be able of test of 80 All the variable had been initially analyzed descriptive For the quantitative variable this analysis was made through the comment of the minimum and maximum values and of the calculation of medium averages and shunting line-standard and For the qualitative variable we calculate absolute and relative frequencies The level of significance used for the tests was of 5 p005The maternal HR values obtained during the procedure showed a significant reduction only in comparison with the other time periods P0001in the two groups The comparison of the groups LE e LNE did not reveal any significant difference P005 ES was detected in 9 290 patients being 7 of them 418 from the Group LE BP did not show any significant difference neither between time periods nor between groups P005 The same occurred in the comparative analysis of the fetal parameters obtained during CTG - number of UC level and variability from baseline of the FHR number of accelerations of the FHR and fetal reactivity pattern Our conclusion was that the use of 2 solution of lidocaine in association with epinephrine proved safe during dental procedure in pregnant women with rheumatic valvar cardiopathy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None