Clinical Trial: Dental Anesthesia in Pregnant Women With Rheumatic Heart Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Maternal-Fetal Monitoring of Patients With Rheumatic Heart Disease During Dental Procedure Under Local Anesthesia

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 1:100,000 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 (29.1%) patients, being 7 (41.8%) 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 Summary: 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 motility(FM) 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 - 56±15.5 minutes (mean±SD); (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 patien
Sponsor: University of Sao Paulo

Current Primary Outcome: Maternal: Blood Pressure, Heart Rate and Extrasystoles; Maternal-Fetal: Fetal Heart Rate, number of uterine contractions, motility and fetal reactivity pattern, in function of presence or not of epinephrine 1:100000 in the 2% solution.of lidocaine [ Time Frame: 4 periods Maternal: (1) Baseline - 60 minutes before the procedure, (2) Procedure, (3) Post-Procedure - 20 minutes, and (4) mean 24-hour; 3 periods Maternal-Fetal: (1) Baseline: 20 minutes before, (2) Procedure, and (3) Post-Procedure - idem maternal ]

Original Primary Outcome: Pregnant women with valvar heart disease [ Time Frame: between the 28th and. 37th week of gestation ]

Current Secondary Outcome: They had been the same analyses used for the Primary Outcome Measures, in function of the gestational age (GA): sub-group GA1 (15 pregnant women between 28 and 31 weeks) and sub-group GA2 (16 pregnant women between 28 and 31 weeks). [ Time Frame: They had been the same periods established for the Time Frame of Primary Outcome Measure ]

Original Secondary Outcome: Rheumatic Heart Disease, undergone the surgery or not [ Time Frame: With the diagnosis of the disease, followed by a cardiologist and a gynecologist, until the moment of this trial ]

Information By: University of Sao Paulo

Dates:
Date Received: June 4, 2007
Date Started: April 2004
Date Completion:
Last Updated: June 4, 2008
Last Verified: June 2008